AVID Medical recall: Halyard medical convenience kits labeled as: 1) ENT and 2 more products

AVID Medical, Inc. is recalling Halyard medical convenience kits labeled as: 1) ENT and 2 more products because of a sterility problem – 11763 kits; 16223 kits; 816 kits. The U.S. Food and Drug Administration published the recall on September 9, 2026; it began on May 19, 2026. Distributed nationwide.

Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

1. Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number (kit) ACEN89-02; 3) BACK PACK, Model/Item Number (kit) ALBK51-01; 4) DR DERIAN SPINE PACK SNEDHCPDH, Model/Item Number (kit) DGSP71; 5) BASIC PACK DR BROWN SBADHBPR16, Model/Item Number (kit) DRBS37; 6) BASIC PACK DR BROWN SBADHBPR16, Model/Item Number (kit) DRBS37-01; 7) NASAL PACK SEN23SNRC3, Model/Item Number (kit) DRNS92; 8) NASAL PACK SEN23SNRC3, Model/Item Number (kit) DRNS92-01; 9) NASAL PACK SEN23SNRC3, Model/Item Number (kit) DRNS92-02; 10) SPINE PACK DR BROWN SNEDHSPR14, Model/Item Number (kit) DRSP26; 11) SPINE PACK DR BROWN SNEDHSPR14, Model/Item Number (kit) DRSP26-01; 12) SPINE PACK DR BROWN SNEDHSPR14, Model/Item Number (kit) DRSP26-02; 13) SPINE DR HEYS PACK SNE23SSRCT, Model/Item Number (kit) DRSP52; 14) SPINE DR HEYS PACK SNE23SSRCT, Model/Item Number (kit) DRSP52-01; 15) OHN LARYNGOSCOPY PACK SEN23BRD, Model/Item Number (kit) DULY32; 16) OHN LARYNGOSCOPY PACK SEN23BRD, Model/Item Number (kit) DULY32-01; 17) MICRO FLAP PK SEN23EN14T, Model/Item Number (kit) DUMF13-01; 18) MICRO FLAP PK SEN23EN14T, Model/Item Number (kit) DUMF13-02; 19) OHN NASAL PROCEDURE PACK SEN23, Model/Item Number (kit) DUNS94; 20) OHN NASAL PROCEDURE PACK SEN23, Model/Item Number (kit) DUNS94-01; 21) ORTHO POSTERIOR SPINE PK SOP23, Model/Item Number (kit) DUPS11-01; 22) ORTHO POSTERIOR SPINE PK, Model/Item Number (kit) DUPS11-02; 23) TRAM PACK SBA95TPDU6, Model/Item Number (kit) DUTM67-01; 24) SPINE PACK 176537, Model/Item Number (kit) DVSP33J; 25) LAMINECTOMY PACK, Model/Item Number (kit) EAMC108-03; 26) OMFS PACK, Model/Item Number (kit) EAMC124; 27) SINUS PACK 711866, Model/Item Number (kit) EFSN20-01; 28) KIT,SPINE, Model/Item Number (kit) EUOR004-04; 29) SPINE PACK 176556, Model/Item Number (kit) HOSP20I; 30) LAMINECTOMY PACK, Model/Item Number (kit) JACK401-07; 31) LAMINECTOMY PACK, Model/Item Number (kit) JACK401-08; 32) LAMINECTOMY PACK, Model/Item Number (kit) JACK401-09; 33) SPINE PACK 176476, Model/Item Number (kit) JCSP60F; 34) BACK PACK, Model/Item Number (kit) JEBK01-01; 35) PEDS SINUS PACK, Model/Item Number (kit) LBPS18-01; 36) SINUS PACK, Model/Item Number (kit) LBSN49-01; 37) ORAL SURGERY MAJOR PACK, Model/Item Number (kit) MAMC251-09; 38) SPINE PACK, Model/Item Number (kit) NAFB071-10; 39) SPINE PACK 176524, Model/Item Number (kit) OSSP27-01; 40) ORAL SURGERY HEAD, Model/Item Number (kit) SAMM029-17; 41) LAMINECTOMY PACK, Model/Item Number (kit) SELF112-03; 42) CPT FSC SINUS PACK, Model/Item Number (kit) SHAN415-01; 43) DR. DELASOTTA PLIF, Model/Item Number (kit) SHOR001-15; 44) DELASOTTA MINOR BACK, Model/Item Number (kit) SHOR005-12; 45) SPINE PACK, Model/Item Number (kit) SLCR80-01; 46) DIEP PACK, Model/Item Number (kit) SLDP19-01; 47) SPINE PACK - MAJOR, Model/Item Number (kit) SPST001-06; 48) ESS TRAY, Model/Item Number (kit) SWMR011-02; 49) SPINE PACK 176547, Model/Item Number (kit) TPSP14-01; 50) LAMINECTOMY PACK, Model/Item Number (kit) VALD009-08; 51) EENT PACK, Model/Item Number (kit) VALV225-02; 52) NEURO PACK, Model/Item Number (kit) VAST008-10; 53) SPINAL FUSION, Model/Item Number (kit) WRNM033-22.

   FDA recall number

   Z-3044-2026

   Codes, lots and dates

   Model/Item Number (kit) ACEN89-01, UDI/DI 10809160459447, Kit Lot Number 1650691; Model/Item Number (kit) ACEN89-01, UDI/DI 10809160496411, Kit Lot Number 1675577; Model/Item Number (kit) ACEN89-01, UDI/DI 10809160459447, Kit Lot Number 1666553; Model/Item Number (kit) ACEN89-02, UDI/DI 10809160505304, Kit Lot Number 1683926; Model/Item Number (kit) ACEN89-02, UDI/DI 10809160505304, Kit Lot Number 1683927; Model/Item Number (kit) ALBK51-01, UDI/DI 10809160458587, Kit Lot Number 1649240; Model/Item Number (kit) ALBK51-01, UDI/DI 10809160458587, Kit Lot Number 1649721; Model/Item Number (kit) ALBK51-01, UDI/DI 10809160496374, Kit Lot Number 1675589; Model/Item Number (kit) DGSP71, UDI/DI 10809160468036, Kit Lot Number 1659332; Model/Item Number (kit) DRBS37, UDI/DI 10809160466858, Kit Lot Number 1658530; Model/Item Number (kit) DRBS37-01, UDI/DI 10809160503829, Kit Lot Number 1681363; Model/Item Number (kit) DRBS37-01, UDI/DI 10809160503829, Kit Lot Number 1681470; Model/Item Number (kit) DRBS37-01, UDI/DI 10809160503829, Kit Lot Number 1691461; Model/Item Number (kit) DRNS92, UDI/DI 10809160466346, Kit Lot Number 1658536; Model/Item Number (kit) DRNS92-01, UDI/DI 10809160503942, Kit Lot Number 1681504; Model/Item Number (kit) DRNS92-02, UDI/DI 10809160509463, Kit Lot Number 1696890; Model/Item Number (kit) DRSP26, UDI/DI 10809160466384, Kit Lot Number 1659340; Model/Item Number (kit) DRSP26-01, UDI/DI 10809160505113, Kit Lot Number 1683469; Model/Item Number (kit) DRSP26-02, UDI/DI 10809160509470, Kit Lot Number 1691780; Model/Item Number (kit) DRSP52, UDI/DI 10809160466391, Kit Lot Number 1658538; Model/Item Number (kit) DRSP52-01, UDI/DI 10809160503928, Kit Lot Number 1681522; Model/Item Number (kit) DRSP52-01, UDI/DI 10809160503928, Kit Lot Number 1690963; Model/Item Number (kit) DULY32, UDI/DI 10809160491713, Kit Lot Number 1672111; Model/Item Number (kit) DULY32-01, UDI/DI 10809160506752, Kit Lot Number 1684863; Model/Item Number (kit) DUMF13-01, UDI/DI 10809160498194, Kit Lot Number 1675866; Model/Item Number (kit) DUMF13-02, UDI/DI 10809160513668, Kit Lot Number 1696000; Model/Item Number (kit) DUNS94, UDI/DI 10809160493380, Kit Lot Number 1672112; Model/Item Number (kit) DUNS94-01, UDI/DI 10809160513309, Kit Lot Number 1696906; Model/Item Number (kit) DUPS11-01, UDI/DI 10809160497654, Kit Lot Number 1675527; Model/Item Number (kit) DUPS11-02, UDI/DI 10809160514245, Kit Lot Number 1696671; Model/Item Number (kit) DUTM67-01, UDI/DI 10809160498255, Kit Lot Number 1675954; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1663944; Model/Item Number (kit) DVSP33J, UDI/DI 10809160422601, Kit Lot Number 1630941; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1668872; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1668873; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1663942; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1663941; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1693905; Model/Item Number (kit) EAMC108-03, UDI/DI 10809160308332, Kit Lot Number 1648525; Model/Item Number (kit) EAMC108-03, UDI/DI 10809160308332, Kit Lot Number 1657459; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1647073; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1652746; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1653958; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1663289; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1668701; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1702932; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160442104, Kit Lot Number 1633240; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1646885; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1679527; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1666246; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1666500; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1667490; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1696290; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1697819; Model/Item Number (kit) EUOR004-04, UDI/DI 10809160436172, Kit Lot Number 1627776; Model/Item Number (kit) EUOR004-04, UDI/DI 10809160457252, Kit Lot Number 1668123; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 1665330; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 1669003; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 1671045; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 1693989; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 1664462; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 374805; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 374807; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 375045; Model/Item Number (kit) JACK401-07, UDI/DI 10809160457122, Kit Lot Number 1647194; Model/Item Number (kit) JACK401-08, UDI/DI 10809160465004, Kit Lot Number 1656191; Model/Item Number (kit) JACK401-08, UDI/DI 10809160465004, Kit Lot Number 1647195; Model/Item Number (kit) JACK401-08, UDI/DI 10809160465004, Kit Lot Number 1664711; Model/Item Number (kit) JACK401-08, UDI/DI 10809160465004, Kit Lot Number 1672072; Model/Item Number (kit) JACK401-08, UDI/DI 10809160465004, Kit Lot Number 1664712; Model/Item Number (kit) JACK401-08, UDI/DI 10809160465004, Kit Lot Number 1656190; Model/Item Number (kit) JACK401-09, UDI/DI 10809160493335, Kit Lot Number 1672074; Model/Item Number (kit) JACK401-09, UDI/DI 10809160493335, Kit Lot Number 1672073; Model/Item Number (kit) JACK401-09, UDI/DI 10809160521922, Kit Lot Number 852288; Model/Item Number (kit) JACK401-09, UDI/DI 10809160521922, Kit Lot Number 852289; Model/Item Number (kit) JACK401-09, UDI/DI 10809160521922, Kit Lot Number 857175; Model/Item Number (kit) JACK401-09, UDI/DI 10809160521922, Kit Lot Number 858450; Model/Item Number (kit) JACK401-09, UDI/DI 10809160521922, Kit Lot Number 863863; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1624320; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1624321; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1632235; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1624322; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1673702; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1664473; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1657644; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1671055; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1662136; Model/Item Number (kit) JEBK01-01, UDI/DI 10809160443132, Kit Lot Number 1634523; Model/Item Number (kit) JEBK01-01, UDI/DI 10809160443132, Kit Lot Number 1634522; Model/Item Number (kit) JEBK01-01, UDI/DI 10809160443132, Kit Lot Number 1643364; Model/Item Number (kit) LBPS18-01, UDI/DI 10809160438169, Kit Lot Number 1630467; Model/Item Number (kit) LBPS18-01, UDI/DI 10809160438169, Kit Lot Number 1630023; Model/Item Number (kit) LBPS18-01, UDI/DI 10809160438169, Kit Lot Number 1639340; Model/Item Number (kit) LBPS18-01, UDI/DI 10809160438169, Kit Lot Number 1658421; Model/Item Number (kit) LBPS18-01, UDI/DI 10809160438169, Kit Lot Number 1666815; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160438183, Kit Lot Number 1639341; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160438183, Kit Lot Number 1629949; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160438183, Kit Lot Number 1635273; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160461396, Kit Lot Number 1652833; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160461396, Kit Lot Number 1652834; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160496459, Kit Lot Number 1676545; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160496459, Kit Lot Number 371520; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160496459, Kit Lot Number 1691995; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160496459, Kit Lot Number 351420; Model/Item Number (kit) MAMC251-09, UDI/DI 10809160504956, Kit Lot Number 1694232; Model/Item Number (kit) NAFB071-10, UDI/DI 10809160466025, Kit Lot Number 1659349; Model/Item Number (kit) NAFB071-10, UDI/DI 10809160466025, Kit Lot Number 1659350; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160437391, Kit Lot Number 1666862; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160437391, Kit Lot Number 1661830; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160437391, Kit Lot Number 1666863; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160437391, Kit Lot Number 1669024; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160437391, Kit Lot Number 1694083; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160437391, Kit Lot Number 1665985; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160522011, Kit Lot Number 1629904; Model/Item Number (kit) SAMM029-17, UDI/DI 10809160439746, Kit Lot Number 1628621; Model/Item Number (kit) SELF112-03, UDI/DI 10809160458761, Kit Lot Number 1669327; Model/Item Number (kit) SELF112-03, UDI/DI 10809160458761, Kit Lot Number 1674472; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1664121; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1622345; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1651571; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1664960; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1669881; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1691644; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1668350; Model/Item Number (kit) SHOR001-15, UDI/DI 10809160390627, Kit Lot Number 1628492; Model/Item Number (kit) SHOR001-15, UDI/DI 10809160390627, Kit Lot Number 1603012; Model/Item Number (kit) SHOR001-15, UDI/DI 10809160390627, Kit Lot Number 1614967; Model/Item Number (kit) SHOR001-15, UDI/DI 10809160390627, Kit Lot Number 1644461; Model/Item Number (kit) SHOR005-12, UDI/DI 10809160390504, Kit Lot Number 1592255; Model/Item Number (kit) SHOR005-12, UDI/DI 10809160390504, Kit Lot Number 1613423; Model/Item Number (kit) SHOR005-12, UDI/DI 10809160390504, Kit Lot Number 1614368; Model/Item Number (kit) SHOR005-12, UDI/DI 10809160390504, Kit Lot Number 1644463; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160440162, Kit Lot Number 1631480; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160440162, Kit Lot Number 1654403; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160488102, Kit Lot Number 1663961; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160440162, Kit Lot Number 1631504; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160488102, Kit Lot Number 1667105; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160488102, Kit Lot Number 1663960; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160488102, Kit Lot Number 1663959; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160488102, Kit Lot Number 1667106; Model/Item Number (kit) SLDP19-01, UDI/DI 10809160487600, Kit Lot Number 1666282; Model/Item Number (kit) SLDP19-01, UDI/DI 10809160487600, Kit Lot Number 1670036; Model/Item Number (kit) SLDP19-01, UDI/DI 10809160450055, Kit Lot Number 1654404; Model/Item Number (kit) SLDP19-01, UDI/DI 10809160487600, Kit Lot Number 1700561; Model/Item Number (kit) SLDP19-01, UDI/DI 10809160487600, Kit Lot Number 1695108; Model/Item Number (kit) SPST001-06, UDI/DI 10809160464809, Kit Lot Number 1656777; Model/Item Number (kit) SPST001-06, UDI/DI 10809160464809, Kit Lot Number 1692410; Model/Item Number (kit) SPST001-06, UDI/DI 10809160464809, Kit Lot Number 1656775; Model/Item Number (kit) SPST001-06, UDI/DI 10809160464809, Kit Lot Number 1656776; Model/Item Number (kit) SWMR011-02, UDI/DI 10809160370872, Kit Lot Number 1659735; Model/Item Number (kit) SWMR011-02, UDI/DI 10809160370872, Kit Lot Number 1666375; Model/Item Number (kit) SWMR011-02, UDI/DI 10809160370872, Kit Lot Number 1673256; Model/Item Number (kit) SWMR011-02, UDI/DI 10809160370872, Kit Lot Number 1673257; Model/Item Number (kit) SWMR011-02, UDI/DI 10809160370872, Kit Lot Number 1680822; Model/Item Number (kit) TPSP14-01, UDI/DI 10809160461143, Kit Lot Number 1664508; Model/Item Number (kit) TPSP14-01, UDI/DI 10809160461143, Kit Lot Number 1666872; Model/Item Number (kit) TPSP14-01, UDI/DI 10809160461143, Kit Lot Number 1668885; Model/Item Number (kit) TPSP14-01, UDI/DI 10809160461143, Kit Lot Number 1691142; Model/Item Number (kit) TPSP14-01, UDI/DI 10809160461143, Kit Lot Number 1653638; Model/Item Number (kit) TPSP14-01, UDI/DI 10809160461143, Kit Lot Number 1666205; Model/Item Number (kit) VALD009-08, UDI/DI 10809160380833, Kit Lot Number 1662413; Model/Item Number (kit) VALD009-08, UDI/DI 10809160380833, Kit Lot Number 1637807; Model/Item Number (kit) VALD009-08, UDI/DI 10809160380833, Kit Lot Number 1645595; Model/Item Number (kit) VALD009-08, UDI/DI 10809160380833, Kit Lot Number 1658681; Model/Item Number (kit) VALD009-08, UDI/DI 10809160380833, Kit Lot Number 1602791; Model/Item Number (kit) VALV225-02, UDI/DI 10809160406250, Kit Lot Number 1629195; Model/Item Number (kit) VAST008-10, UDI/DI 10809160461334, Kit Lot Number 1641263; Model/Item Number (kit) WRNM033-22, UDI/DI 10809160470114, Kit Lot Number 1667341.

   Quantity

   11763 kits

   Classification

   Class II

2. 1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKCR19-01; 4) ORTHO SPINE PACK, (kit) ARMC017; 5) BMHM NEURO PACK, (kit) BMHT016-05; 6) LUMBAR PACK, (kit) BMHT112-03; 7) NEURO LAMINECTOMY PACK, (kit) DGNE75; 8) NEURO LAMINECTOMY PACK, (kit) DGNE75-02; 9) DRAH NEURO LAMINECTOMY SNEDHDN,(kit) DRNE75; 10) DRAH NEURO LAMINECTOMY SNEDHDN, (kit) DRNE75-01; 11) CRANIOSYNOSTOSIS CUSTOM SNE23C, (kit) DUCR36-01; 12) CRANIOSYNOSTOSIS CUSTOM SNE23C, (kit) DUCR36-02; 13) NEURO CRANIOTOMY PK SNE23C1116, (kit) DUNC42-01; 14) PEDS NEURO PACK SNE2301147, (kit) DUNE88-01; 15) NEURO SPINE PACK SNE23LM110, (kit) DUSP98-01; 16) NEURO SPINE PACK SNE23LM110, (kit) DUSP98-02; 17) CRANI PACK 712638, (kit) EFCR86-01; 18) SPINE PACK 712040, (kit) EFSP30-01; 19) SPINE PACK 712040, (kit) EFSP30-02; 20) CRANIOTOMY TRAY, (kit) EURO009-09; 21) CRANI PACK, (kit) IHCR36-01; 22) NEURO PACK, (kit) IHNE35-01; 23) CRANIOTOMY PACK, (kit) JACK410-11; 24) BASIC NEURO PACK, (kit) MAMC275-06; 25) BASIC NEURO PACK, (kit) MAMC275-07; 26) SPINE CRANI PACK, (kit) MCSP92-01; 27) CRANIOTOMY PACK, (kit) MECP05R; 28) SPINE TRAY GLOBALMICROSURG, (kit) MEDF217-02; 29) NEURO BASIC PACK, (kit) MENE06T; 30) CRANIAL PACK - 205992, (kit) MHCP75-01; 31) NEURO PACK, (kit) MMOK007-03; 32) NEURO PACK, (kit) MMTN012-04; 33) CRANIOTOMY PACK SNECGCRM11, (kit) MSMC108-01; 34) NEURO ANT CERV LAMI ADD A PACK, (kit) NAMC413-07; 35) STRL NEURO LUMB LAMI ADD A PK, (kit) NAMC433-05; 36) NEURO CRANI ADD A PACK, (kit) NAMC434-08; 37) NEURO PACK, (kit) NWHR010-03; 38) CRANIOTOMY PACK OSBORN 176518, (kit) OSCR20-01; 39) NEURO PACK, (kit) RDLD001-14; 40) CRANI PACK, (kit) RDLD008-14; 41) NEURO LUMBAR CERVICAL PACK,(kit) SAMM031-18; 42) CRANIOTOMY PACK, (kit) SELF111-02; 43) PELHAM ACDF, (kit) SGAC31-02; 44) PELHAM ACDF, (kit) SGAC31-03; 45) PELHAM MINA SPINE, (kit) SGSP11; 46) PELHAM MINA SPINE, (kit) SGSP11-03; 47) PELHAM SPINE, (kit) SGSP44-02; 48) PELHAM SPINE, (kit) SGSP44-03; 49) SPINE, (kit) SGSP91; 50) SPINE, (kit) SGSP91-02; 51) SPINE, (kit) SGSP91-03; 52) NEURO SPINAL TRAY SHANDS JACKS, (kit) SHND416-02; 53) DR. DELASOTTA NEURO NECK, (kit) SHOR003-15; 54) CRANI PACK, (kit) SLCN72-01; 55) CRANI PACK, (kit) SLCN72-02; 56) CRANI PACK, (kit) SLCN72-03; 57) CRANI PACK - 208400, (kit) UDCP57-01; 58) NEURO TRAY-LF, (kit) UMIA104-11; 59) CRANIOTOMY PACK, (kit) USMA005; 60) CERVICAL NEURO PACK PGYBK, (kit) VAML012-07; 61) LUMBAR NEURO PACK PGYBK, (kit) VAML028-06; 62) NASAL SINUS, (kit) VAPX009-02; 63) LUMBAR LAMINECTOMY TRAY, (kit) VMCC024-14; 64) VA LUMBAR LAMINECTOMY, (kit) VMED009-05; 65) ANTERIOR CERVICAL PACK, (kit) WEAC53-01; 66) CRANI PACK, (kit) WECR41-01; 67) LUMBAR LAMINECTOMY PACK,67) LUMBAR LAMINECTOMY PACK, Model/Item Number (kit) WELL73-01; 68) LUMBAR LAMINECTOMY, (kit) WKMC114-03; 69) CRANIOTOMY PK, (kit) WKMC125-03; 70) DISKECTOMY PACK, (kit) WRNM030-21.

   FDA recall number

   Z-3045-2026

   Codes, lots and dates

   Model/Item Number (kit) ACNE73-01, UDI/DI 10809160458532, Kit Lot Number 1649716; Model/Item Number (kit) ACNE73-01, UDI/DI 10809160458532, Kit Lot Number 1666559; Model/Item Number (kit) ACNE73-01, UDI/DI 10809160458532, Kit Lot Number 1649717; Model/Item Number (kit) ACNE73-03, UDI/DI 10809160513996, Kit Lot Number 1696563; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1650945; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1666564; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1664544; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1666978; Model/Item Number (kit) ARMC017, UDI/DI 10809160506455, Kit Lot Number 1685117; Model/Item Number (kit) ARMC017, UDI/DI 10809160506455, Kit Lot Number 1688043; Model/Item Number (kit) ARMC017, UDI/DI 10809160506455, Kit Lot Number 1688044; Model/Item Number (kit) BMHT016-05, UDI/DI 10809160468821, Kit Lot Number 1666733; Model/Item Number (kit) BMHT016-05, UDI/DI 10809160468821, Kit Lot Number 1659950; Model/Item Number (kit) BMHT112-03, UDI/DI 10809160457634, Kit Lot Number 1649141; Model/Item Number (kit) BMHT112-03, UDI/DI 10809160404430, Kit Lot Number 1606455; Model/Item Number (kit) DGNE75, UDI/DI 10809160468104, Kit Lot Number 1659330; Model/Item Number (kit) DGNE75-02, UDI/DI 10809160510001, Kit Lot Number 1688056; Model/Item Number (kit) DRNE75, UDI/DI 10809160467190, Kit Lot Number 1658535; Model/Item Number (kit) DRNE75-01, UDI/DI 10809160503843, Kit Lot Number 1681499; Model/Item Number (kit) DRNE75-01, UDI/DI 10809160503843, Kit Lot Number 1691081; Model/Item Number (kit) DUCR36-01, UDI/DI 10809160497388, Kit Lot Number 1675499; Model/Item Number (kit) DUCR36-02, UDI/DI 10809160513538, Kit Lot Number 1691089; Model/Item Number (kit) DUNC42-01, UDI/DI 10809160497524, Kit Lot Number 1675518; Model/Item Number (kit) DUNC42-01, UDI/DI 10809160497524, Kit Lot Number 1686203; Model/Item Number (kit) DUNC42-01, UDI/DI 10809160497524, Kit Lot Number 1686204; Model/Item Number (kit) DUNE88-01, UDI/DI 10809160498217, Kit Lot Number 1675520; Model/Item Number (kit) DUSP98-01, UDI/DI 10809160497708, Kit Lot Number 1680111; Model/Item Number (kit) DUSP98-02, UDI/DI 10809160513392, Kit Lot Number 1691105; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160442210, Kit Lot Number 1633353; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160456026, Kit Lot Number 1694281; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160456026, Kit Lot Number 1691158; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160442210, Kit Lot Number 374076; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1648983; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1646886; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1649731; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1633403; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1669417; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1678530; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1670304; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1691551; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1669415; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1680385; Model/Item Number (kit) EURO009-09, UDI/DI 10809160414217, Kit Lot Number 1649363; Model/Item Number (kit) IHCR36-01, UDI/DI 10809160477557, Kit Lot Number 344863; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 343178; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 343377; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 343179; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348826; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348828; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348829; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348830; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348834; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348835; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1664733; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1656356; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1667191; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 838447; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1664206; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1664732; Model/Item Number (kit) MAMC275-06, UDI/DI 10809160421666, Kit Lot Number 1644895; Model/Item Number (kit) MAMC275-07, UDI/DI 10809160495902, Kit Lot Number 1675387; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1652837; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160442999, Kit Lot Number 1633247; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160442999, Kit Lot Number 1633983; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1670241; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160442999, Kit Lot Number 1636102; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160442999, Kit Lot Number 1633985; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1670240; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160514719, Kit Lot Number 1697302; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1674543; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1670238; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1680358; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1691128; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160514719, Kit Lot Number 1700133; Model/Item Number (kit) MECP05R, UDI/DI 10809160418109, Kit Lot Number 1658933; Model/Item Number (kit) MECP05R, UDI/DI 10809160418109, Kit Lot Number 1694755; Model/Item Number (kit) MECP05R, UDI/DI 10809160417331, Kit Lot Number 1671174; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160382912, Kit Lot Number 1632022; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160382912, Kit Lot Number 1628605; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160459706, Kit Lot Number 1651140; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160459706, Kit Lot Number 1651139; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160459706, Kit Lot Number 1651141; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160459706, Kit Lot Number 1651142; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1671525; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1652669; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1654982; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1652667; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1652668; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1646454; Model/Item Number (kit) MHCP75-01, UDI/DI 10809160479568, Kit Lot Number 345849; Model/Item Number (kit) MMOK007-03, UDI/DI 10809160460764, Kit Lot Number 1696427; Model/Item Number (kit) MMTN012-04, UDI/DI 10809160444085, Kit Lot Number 1644099; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1623100; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1650608; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1623102; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1639185; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1657124; Model/Item Number (kit) NAMC413-07, UDI/DI 10809160374306, Kit Lot Number 1652550; Model/Item Number (kit) NAMC433-05, UDI/DI 10809160417584, Kit Lot Number 1629049; Model/Item Number (kit) NAMC433-05, UDI/DI 10809160417584, Kit Lot Number 1656868; Model/Item Number (kit) NAMC434-08, UDI/DI 10809160417584, Kit Lot Number 1649106; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1681967; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1656161; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1688028; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1675548; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1664880; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1684189; Model/Item Number (kit) OSCR20-01, UDI/DI 10809160436370, Kit Lot Number 1664480; Model/Item Number (kit) RDLD001-14, UDI/DI 10809160467374, Kit Lot Number 1658194; Model/Item Number (kit) RDLD001-14, UDI/DI 10809160467374, Kit Lot Number 1658423; Model/Item Number (kit) RDLD001-14, UDI/DI 10809160467374, Kit Lot Number 1658192; Model/Item Number (kit) RDLD001-14, UDI/DI 10809160467374, Kit Lot Number 1691893; Model/Item Number (kit) RDLD008-14, UDI/DI 10809160467367, Kit Lot Number 1658206; Model/Item Number (kit) SAMM031-18, UDI/DI 10809160494363, Kit Lot Number 1672515; Model/Item Number (kit) SELF111-02, UDI/DI 10809160458808, Kit Lot Number 1651950; Model/Item Number (kit) SELF111-02, UDI/DI 10809160458808, Kit Lot Number 1652543; Model/Item Number (kit) SGAC31-02, UDI/DI 10809160469491, Kit Lot Number 1661052; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1667346; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1673274; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1667347; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1668002; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1691061; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1700807; Model/Item Number (kit) SGSP11, UDI/DI 10809160461730, Kit Lot Number 1656113; Model/Item Number (kit) SGSP11-03, UDI/DI 10809160511145, Kit Lot Number 1668007; Model/Item Number (kit) SGSP11-03, UDI/DI 10809160511145, Kit Lot Number 1691439; Model/Item Number (kit) SGSP11-03, UDI/DI 10809160511145, Kit Lot Number 1668009; Model/Item Number (kit) SGSP11-03, UDI/DI 10809160511145, Kit Lot Number 1668008; Model/Item Number (kit) SGSP44-02, UDI/DI 10809160469620, Kit Lot Number 1661236; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1668013; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1676432; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1668011; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1668014; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1667304; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1668012; Model/Item Number (kit) SGSP91, UDI/DI 10809160462102, Kit Lot Number 1656747; Model/Item Number (kit) SGSP91, UDI/DI 10809160462102, Kit Lot Number 1653016; Model/Item Number (kit) SGSP91-02, UDI/DI 10809160469644, Kit Lot Number 1661240; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1671768; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1671769; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1667616; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1673361; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1673362; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1691066; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1574836; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1579673; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1582963; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1588397; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1589834; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1590905; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1603715; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1610818; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1655825; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1609281; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1603716; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1648191; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1653849; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1611976; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1622358; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1617996; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1660322; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1665018; Model/Item Number (kit) SHND416-02, UDI/DI 10809160502297, Kit Lot Number 1680232; Model/Item Number (kit) SHND416-02, UDI/DI 10809160502297, Kit Lot Number 1691224; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160390498, Kit Lot Number 1566522; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160390498, Kit Lot Number 1568213; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160411513, Kit Lot Number 1612999; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160411513, Kit Lot Number 1613422; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160411513, Kit Lot Number 1644462; Model/Item Number (kit) SLCN72-01, UDI/DI 10809160446416, Kit Lot Number 1636631; Model/Item Number (kit) SLCN72-02, UDI/DI 10809160457030, Kit Lot Number 1647141; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1667104; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1662160; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1662162; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1668135; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1691204; Model/Item Number (kit) UDCP57-01, UDI/DI 10809160483404, Kit Lot Number 345399; Model/Item Number (kit) UMIA104-11, UDI/DI 10809160465189, Kit Lot Number 1664831; Model/Item Number (kit) UMIA104-11, UDI/DI 10809160465189, Kit Lot Number 1664832; Model/Item Number (kit) USMA005, UDI/DI 10809160388297, Kit Lot Number 1669219; Model/Item Number (kit) USMA005, UDI/DI 10809160388297, Kit Lot Number 1680592; Model/Item Number (kit) VAML012-07, UDI/DI 10809160379011, Kit Lot Number 1612231; Model/Item Number (kit) VAML028-06, UDI/DI 10809160379127, Kit Lot Number 1626107; Model/Item Number (kit) VAPX009-02, UDI/DI 10809160302491, Kit Lot Number 1694165; Model/Item Number (kit) VMCC024-14, UDI/DI 10809160458891, Kit Lot Number 1653475; Model/Item Number (kit) VMED009-05, UDI/DI 10809160487808, Kit Lot Number 1663908; Model/Item Number (kit) VMED009-05, UDI/DI 10809160487808, Kit Lot Number 1663979; Model/Item Number (kit) WEAC53-01, UDI/DI 10809160485347, Kit Lot Number 349078; Model/Item Number (kit) WECR41-01, UDI/DI 10809160485392, Kit Lot Number 348573; Model/Item Number (kit) WECR41-01, UDI/DI 10809160485392, Kit Lot Number 348575; Model/Item Number (kit) WECR41-01, UDI/DI 10809160485392, Kit Lot Number 348673; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 344499; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348358; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348360; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348364; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348402; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348409; Model/Item Number (kit) WKMC114-03, UDI/DI 10809160448069, Kit Lot Number 1652912; Model/Item Number (kit) WKMC114-03, UDI/DI 10809160448069, Kit Lot Number 1660282; Model/Item Number (kit) WKMC125-03, UDI/DI 10809160448113, Kit Lot Number 1641373; Model/Item Number (kit) WRNM030-21, UDI/DI 10809160441961, Kit Lot Number 1661529.

   Quantity

   16223 kits

   Classification

   Class II

3. Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01; 3) ANEURYSM PACK, Model/Item Number (kit) BPAY14-01; 4) SPINE PACK, Model/Item Number (kit) HSLM53-01; 5) ANTERIOR CERVICAL PACK - 205988, Model/Item Number (kit) MHAC65-01; 6) SPINE PACK - 206013, Model/Item Number (kit) MHSP99-01; 7) CRANI PACK, Model/Item Number (kit) WECR41-01.

   FDA recall number

   Z-3046-2026

   Codes, lots and dates

   Model/Item Number (kit) ANAP22-01, UDI/DI 10809160473146, Kit Lot Number 346967; Model/Item Number (kit) ANAP22-01, UDI/DI 10809160473146, Kit Lot Number 346982; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343413; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343414; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343713; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343715; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343716; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343412; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343416; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343714; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343717; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343718; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343719; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343723; Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 343746; Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 343747; Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 343771; Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 374128; Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 374129; Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 374296; Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 342005; Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 344071; Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 347906; Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 341835; Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 343206; Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 343208; Model/Item Number (kit) MHAC65-01, UDI/DI 10809160479537, Kit Lot Number 345289; Model/Item Number (kit) MHSP99-01, UDI/DI 10809160479797, Kit Lot Number 345694; Model/Item Number (kit) MHSP99-01, UDI/DI 10809160479797, Kit Lot Number 341654; Model/Item Number (kit) WECR41-01, UDI/DI 10809160485392, Kit Lot Number 344464.

   Quantity

   816 kits

   Classification

   Class II

FDA event ID

99469

Initiated

Voluntary: Firm initiated

Status

Ongoing

Firm location

Toano, VA, United States

Date	Recall	Problem	Agency
Sep 30, 2026	AVID Medical recall: Halyard IV START KIT NON-STERILEMedical devices · 288 kits (6 cases)	Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminat… Most serious	FDA Class I
Sep 30, 2026	AVID Medical recall: Halyard IV START KIT NON-STERILEMedical devices · 816 kits (17 cases); 192 kits (4 cases)	Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an op… Serious	FDA Class II
Sep 23, 2026	AVID Medical recall: Halyard IV START KIT NON-STERILE REF: KRIV26-02Medical devices · 288 units	Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators whi… Most serious	FDA Class I
Sep 23, 2026	AVID Medical recall: Haylard and 3 more productsMedical devices · 1640 kits; 80 kits; 240 kits; 340 kits	a sterility problem Most serious	FDA Class I
Sep 16, 2026	AVID Medical recall: Halyard IV Start Kit Non-Sterile REF: KRIV26-02Medical devices · 98 Kits	a sterility problem Serious	FDA Class II
Sep 2, 2026	AVID Medical recall: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK and 1 more productMedical devices · 45 kits; 63 kits; 78 kits; 120 Kits; 130 KITS	Labeling Deficiency: The medical kit labeling fails to identify that the statlock componen… Serious	FDA Class II
Aug 26, 2026	AVID Medical recall: Halyard LAVH PACKMedical devices · 40 packs	The kit component was subjected to EO sterilization, contrary to the manufacturer recommen… Serious	FDA Class II

All 8 AVID Medical recalls →

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.