FDA · Class II · September 16, 2026
Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.
C.R. Bard recall: Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914… and 5 more products
C.R. Bard Inc is recalling Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914… and 5 more products – 12,463 trays/kits; 283883 trays/kits; 212580; 391720 units/kits; 33850 units/kits; 364. The U.S. Food and Drug Administration published the recall on September 16, 2026; it began on June 25, 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.
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| Product | Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914… and 5 more products |
| Brand | C.R. Bard |
| Company | C.R. Bard Inc |
| Type | Medical devices |
| Classification | Class II |
| Recall date | June 25, 2026 |
| Published by FDA | September 16, 2026 |
| Quantity | 12,463 trays/kits; 283883 trays/kits; 212580; 391720 units/kits; 33850 units/kits; 364 |
| Recall ID | 98840 |
As listed by FDA
Recalled products (6)
- Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801¿ 10801741024808 00801741024818¿ 10801741024815 00801741024825¿ 10801741024822 SureStep" Foley Tray System with Bardex¿ Lubricath Temp Sensing Foley Catheter REF: A119416M UDI code: 00801741073700 10801741073707 SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800361 UDI code: 00801741073939 10801741073936 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A899616 UDI code: 00801741104534¿ 10801741104531 SureStep" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter REF: A899914 UDI code: 00801741074004 10801741074001 SureStep" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter REF: A899916 UDI code: 00801741074011¿ 10801741074018 SureStep" Foley Tray System Bardex¿ Lubricath¿ Temperature Sensing Catheter REF: A900216 UDI code: 00801741120978¿ 10801741120975 SureStep" Foley Tray System Bard¿Lubricath¿ Foley Catheter REF: A902914 A902916 A902918 UDI code: 00801741074066¿10801741074063 00801741074073 10801741074070 00801741074080¿10801741074087 Bard¿ Urine Meter Foley Catheter Tray With Bardex¿ Lubricath¿ Foley Catheter REF: 304916 UDI code: 00801741019736 01801741019739 Bard¿ Urine Meter Foley Catheter Tray With Bardex¿ Lubricath¿ Foley Catheter REF: 902916 UDI codes: 00801741024863 10801741024860 (416A) SureStep Foley Tray System Bardex IC Complete Care (714A/716A/718A)SureStep Foley Tray System Bardex IC Complete REF: A304914 A304916 A304918 UDI codes: 00801741104350¿ 10801741104357 00801741104367¿ 10801741104364 00801741100499¿ 10801741100496 SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800365 UDI codes: 00801741073960 10801741073967 SureStep" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter REF: A899918 UDI codes: 00801741074028 10801741074025 SureStep" Foley Tray System Bard¿Lubricath¿ Foley Catheter REF: A902618 UDI codes: 00801741104640 10801741104647 SureStep" Foley Tray System Bard¿Lubricath¿ Foley Catheter REF: A902616 UDI codes: 00801741104633¿ 10801741104630 SureStep Intermittent Catheter Tray REF: INTL16C UDI codes: 00801741183195¿ 10801741183192 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
- FDA recall number
- Z-3114-2026
- Codes, lots and dates
- Catalog Numbers / UDI codes: 899914 / 00801741024801¿ 10801741024808 Lot Number: NGKU4611 899916 / 00801741024818¿ 10801741024815 Lot Numbers: NGKU2448 NGKU4610 899918 / 00801741024825¿ 10801741024822 Lot Number: NGKU3555 ***** SureStep" Foley Tray System with Bardex¿ Lubricath Temp Sensing Foley Catheter REF: A119416M UDI code: 00801741073700 10801741073707 SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800361 UDI code: 00801741073939 10801741073936 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A899616 UDI code: 00801741104534¿ 10801741104531 SureStep" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter REF: A899914 UDI code: 00801741074004 10801741074001 SureStep" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter REF: A899916 UDI code: 00801741074011¿ 10801741074018 SureStep" Foley Tray System Bardex¿ Lubricath¿ Temperature Sensing Catheter REF: A900216 UDI code: 00801741120978¿ 10801741120975 SureStep" Foley Tray System Bard¿Lubricath¿ Foley Catheter REF: A902914 A902916 A902918 UDI code: 00801741074066¿10801741074063 00801741074073 10801741074070 00801741074080¿10801741074087 Bard¿ Urine Meter Foley Catheter Tray With Bardex¿ Lubricath¿ Foley Catheter REF: 304916 UDI code: 00801741019736 01801741019739 Bard¿ Urine Meter Foley Catheter Tray With Bardex¿ Lubricath¿ Foley Catheter REF: 902916 UDI codes: 00801741024863 10801741024860 (416A) SureStep Foley Tray System Bardex IC Complete Care (714A/716A/718A)SureStep Foley Tray System Bardex IC Complete REF: A304914 A304916 A304918 UDI codes: 00801741104350¿ 10801741104357 00801741104367¿ 10801741104364 00801741100499¿ 10801741100496 SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800365 UDI codes: 00801741073960 10801741073967 SureStep" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter REF: A899918 UDI codes: 00801741074028 10801741074025 SureStep" Foley Tray System Bard¿Lubricath¿ Foley Catheter REF: A902618 UDI codes: 00801741104640 10801741104647 SureStep" Foley Tray System Bard¿Lubricath¿ Foley Catheter REF: A902616 UDI codes: 00801741104633¿ 10801741104630 SureStep Intermittent Catheter Tray REF: INTL16C UDI codes: 00801741183195¿ 10801741183192
- Quantity
- 12,463 trays/kits
- Classification
- Class II
- Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924¿ 10801741024921 00801741024931¿ 10801741024938 00801741024948¿ 10801741024945 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray REF: 300416A UDI code: 00801741024580 10801741024587 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A300416A UDI code: 00801741073762¿ 10801741073769 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care REF: A303416A UDI code: 00801741073823 10801741073820 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A307416A A307418A UDI codes: 00801741104381¿ 10801741104388 00801741100505¿ 10801741100502 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray REF: A897516 UDI code: 00801741073984 10801741073981 SureStep" Foley Tray System Bardex¿ All- Silicone Foley Catheter Tray REF: A902416 UDI code: 00801741074042¿ 10801741074049 SureStep" Foley Tray System Bardex¿ All- Silicone Foley Catheter Tray REF: A902418 UDI code: 00801741074059¿ 10801741074056 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter REF: A907316 UDI code: 00801741104749¿ 10801741104746 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter REF: A942210 UDI code: 00801741100567¿ 10801741100564 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter REF: A942212 UDI code: 00801741100536¿ 10801741100533 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray REF: A942214 UDI code: 00801741074103¿ 10801741074100 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray REF: A942216 UDI code: 00801741074110 10801741074117 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter REF: A947316 UDI code: 00801741074141 10801741074148 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter REF: A942206 UDI code: 00801741100543 10801741100540 **** Lubri-Sil¿ I.C. Complete Care¿ Temp-Sensing Foley Catheter Tray and Urine Meter REF: 319516AM UDI code: 00801741024696¿ 10801741024693 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Temp Sensing Foley Catheter REF: A119214M UDI code: 00801741073670¿ 10801741073677 REF: A119216M UDI code: 00801741073687 10801741073684 SureStep" Foley Tray Lubri-Sil¿ I.C. Complete Care¿ Temp Sensing Catheter REF: A300916A UDI code: 00801741120862¿ 10801741120869 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A319516A UDI code: 00801741100338 10801741100335 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A319516AM UDI code: 00801741073892 10801741073899 SureStep" Foley Tray Lubri-Sil¿ I.C. Complete Care¿ Temp Sensing Catheter REF: A900916A UDI code: 00801741121029¿ 10801741121026 SureStep" Foley Tray System Lubri-Sil¿ Temperature Sensing Foley Catheter REF: A909216M UDI code: 00801741104763¿ 10801741104760 ***** Bard¿ Urine Meter Foley Catheter Tray With Bard¿ Lubri-Sil¿ Catheter REF 942208 UDI code: 00801741029370 10801741029377 Bard¿ Urine Meter Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 942216 UDI code: 00801741024979 10801741024976 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray and Urine Meter REF: 303416A UDI code: 00801741024726 10801741024723 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Temp Sensing Foley Catheter REF: A119218M UDI code: 00801741073694 10801741073691 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A300418A UDI code: 00801741073779 10801741073776 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A303418A UDI code: 00801741073830 10801741073837 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A319514AM UDI code: 00801741073885 10801741073882 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter REF: A942208 UDI code: 00801741100550 10801741100557 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray REF: A942218 UDI code: 00801741074127 10801741074124 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley
- FDA recall number
- Z-3115-2026
- Codes, lots and dates
- Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter Catalog Numbers / UDI codes: 947314 / 00801741024924¿ 10801741024921 Lot Numbers: NGKT2599 NGKU0115 947316 / 00801741024931¿ 10801741024938 Lot Numbers: NGKU0162 NGKU2507 947318 / 00801741024948¿ 10801741024945 Lot Numbers: NGKU2420 NGKU2865 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray 300416A / 00801741024580 10801741024587 Lot Numbers: NGKT1464 NGKU0129 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A300416A / 00801741073762¿ 10801741073769 Lot Numbers: NGKT3316 NGKU0946 NGKU0972 NGKU1747 NGKU1823 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care A303416A / 00801741073823 10801741073820 Lot Numbers: NGKT2388 NGKT2495 NGKT3290 NGKT3303 NGKT3318 NGKU0949 NGKU0974 NGKU1749 NGKU2011 NGKU2036 NGKU2922 NGKV0359 NGKV0360 NGKV1433 NGKV1454 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A307416A / 00801741104381 10801741104388 Lot Number: NGKS3764 A307418A / 00801741100505 10801741100502 Lot Number: NGKT2453 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray A897516 / 00801741073984 10801741073981 Lot Numbers: NGKT3226 NGKU0841 NGKU0954 SureStep" Foley Tray System Bardex¿ All- Silicone Foley Catheter Tray A902416 / 00801741074042¿ 10801741074049 Lot Numbers: NGKU0843 NGKU2016 NGKU2049 NGKU2887 NGKU2929 NGKU3049 NGKU3975 NGKU4043 NGKU4716 SureStep" Foley Tray System Bardex¿ All- Silicone Foley Catheter Tray A902418 / 00801741074059¿ 10801741074056 Lot Number: NGKU0956 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter A907316 / 00801741104749¿ 10801741104746 Lot Number: NGKU0855 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter A942210 / 00801741100567¿ 10801741100564 Lot Number: NGKT2458 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter A942212 / 00801741100536¿ 10801741100533 Lot Number: NGKT3373 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray A942214 / 00801741074103¿ 10801741074100 Lot Number: NGKT3232 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray A942216 / 00801741074110 10801741074117 Lot Numbers: NGKT3366 NGKT3374 NGKT3375 NGKT3394 NGKT3395 NGKU0845 NGKU0856 NGKU0957 NGKU1003 NGKU1004 NGKU1757 NGKU1850 NGKU2021 NGKU2052 NGKU2890 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter A947316 / 00801741074141 10801741074148 Lot Numbers: NGKT2396 NGKT2416 NGKT2460 NGKT3368 NGKT3377 NGKU0846 NGKU0857 NGKU0958 NGKU1758 NGKU1851 NGKU2022 NGKU4047 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter A942206 / 00801741100543 10801741100540 Lot Number: NGKT3364 ***** Lubri-Sil¿ I.C. Complete Care¿ Temp-Sensing Foley Catheter Tray and Urine Meter 319516AM / 00801741024696¿ 10801741024693 Lot Number: NGKU1994 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Temp Sensing Foley Catheter A119214M / 00801741073670¿ 10801741073677 Lot Number: NGKV0292 A119216M / 00801741073687 10801741073684 Lot Numbers: NGKS3759 NGKT1887 NGKT2383 NGKT2404 NGKT3314 NGKU0971 SureStep" Foley Tray Lubri-Sil¿ I.C. Complete Care¿ Temp Sensing Catheter A300916A / 00801741120862¿ 10801741120869 Lot Number: NGKS4948 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A319516A / 00801741100338 10801741100335 Lot Number: NGKT1899 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A319516AM / 00801741073892 10801741073899 Lot Numbers: NGKS4850 NGKT0702 NGKT0768 NGKT1863 NGKT2391 NGKT2412 NGKT2455 NGKT3305 NGKU0978 NGKU1025 NGKU2925 SureStep" Foley Tray Lubri-Sil¿ I.C. Complete Care¿ Temp Sensing Catheter A900916A / 00801741121029¿ 10801741121026 Lot Number: NGKS4959 SureStep" Foley Tray System Lubri-Sil¿ Temperature Sensing Foley Catheter A909216M / 00801741104763¿ 10801741104760 Lot Number: NGKT2394 ***** Bard¿ Urine Meter Foley Catheter Tray With Bard¿ Lubri-Sil¿ Catheter 942208 / 00801741029370 10801741029377 Lot Number: NGKW2677 Bard¿ Urine Meter Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter 942216 / 00801741024979 10801741024976 Lot Numbers: NGKW2822 NGKW2751 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray and Urine Meter 303416A / 00801741024726 10801741024723 Lot Numbers: NGKW3769 NGKW0682 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Temp Sensing Foley Catheter A119218M / 00801741073694 10801741073691 Lot Number: NGKW0605 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A300418A / 00801741073779 10801741073776 Lot Number: NGKX3768 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A303418A / 00801741073830 10801741073837 Lot Numbers: NGKW1796 NGKV1455 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A319514AM / 00801741073885 10801741073882 Lot Numbers: NGKW2687 NGKV2393 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter A942208 / 00801741100550 10801741100557 Lot Number: NGKV3560 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray A942218 / 00801741074127 10801741074124 Lot Number: NGKX4530 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter A947314 / 00801741074134 10801741074131 Lot Numbers: NGKW0616 NGKV4999 NGKV3635 NGKV2289
- Quantity
- 283883 trays/kits
- Classification
- Class II
- Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray REF: 300316A UDI codes: 00801741024344¿ 10801741024341 *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray and Urine Meter REF: 303314A 303316A 303318A UDI code: 00801741024252¿ 10801741024259 00801741024269 10801741024266 00801741024276¿ 10801741024273 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314A UDI codes: 00801741073724¿ 10801741073721 REF: A300314AC (Canada Only) UDI-DI code: 00801741143243 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300316A UDI code: 00801741073731 10801741073738 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300318A UDI code: 00801741073748¿ 10801741073745 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A303314A A303316A A303318A UDI code: 00801741073786¿ 10801741073783 00801741073793¿ 10801741073790 00801741073809¿ 10801741073806 *SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A303414A UDI code: 00801741073816¿ 10801741073813 *(416A)SureStep" Foley Tray System Bardex¿ IC Complete Care¿ (714A/716A/718A)SureStep" Foley Tray System Bardex¿ IC Complete Care¿ (914)SureStep" Foley Tray System REF: A304716A A304714A A304716A A304718A UDI code: 00801741104206¿ 10801741104203 00801741104268 10801741104265 00801741104299¿ 10801741104296 00801741100376¿ 10801741100373 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A319416A UDI code: 00801741100307¿ 10801741100304 *SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter REF: A319416AM UDI code: 00801741073861¿ 10801741073868 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A319418A UDI code: 00801741100314¿ 10801741100311 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A903316A UDI code: 00801741096600¿ 10801741096607 ***** SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care REF: A300414A UDI code: 00801741073755 10801741073752 SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter REF: A319414AM UDI code: 00801741073854 10801741073851 SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter REF: A319418AM UDI code: 00801741073878 10801741073875 SureStep" Foley Tray System Bardex¿ IC Complete Care REF: A903318A UDI code: 00801741104657 10801741104654 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
- FDA recall number
- Z-3116-2026
- Codes, lots and dates
- Bardex¿ I.C. Complete Care¿ Foley Catheter Tray 300316A / 00801741024344¿ 10801741024341 Lot Number: NGKT3657 Bardex¿ I.C. Complete Care¿ Foley Catheter Tray and Urine Meter 303314A / 00801741024252¿ 10801741024259 Lot Number: NGKU4153 303316A / 00801741024269 10801741024266 Lot Number: NGKW2883 303318A / 00801741024276¿ 10801741024273 Lot Number: NGKU0966 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A300314A / 00801741073724¿ 10801741073721 Lot Number: NGKU1020 A300314AC (Canada Only) / 00801741143243 Lot Number: **** SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A300316A / 00801741073731 10801741073738 Lot Numbers: NGKT2448 NGKT3221 NGKT3288 NGKT3301 NGKT3315 NGKU2921 NGKV0293 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A300318A / 00801741073748¿ 10801741073745 Lot Number: NGKT2493 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A303314A / 00801741073786¿ 10801741073783 Lot Numbers: NGKT3222 NGKV0249 A303316A / 00801741073793¿ 10801741073790 Lot Numbers: NGKU0894 NGKU0947 NGKU0973 NGKU1021 NGKU1748 NGKU1826 NGKU1830 NGKU2034 NGKU2035 NGKU2996 NGKU3042 NGKU3969 NGKU4037 NGKU4077 NGKU4078 NGKU4135 NGKU4713 NGKU4714 NGKU4720 NGKU4721 NGKU4722 NGKU4727 NGKV2390 NGKV3390 A303318A / 00801741073809¿ 10801741073806 Lot Numbers: NGKT3223 NGKU4136 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A303414A / 00801741073816¿ 10801741073813 Lot Number: NGKU1022 (416A)SureStep" Foley Tray System Bardex¿ IC Complete Care¿ (714A/716A/718A)SureStep" Foley Tray System Bardex¿ IC Complete Care¿ (914)SureStep" Foley Tray System A304716A / 00801741104206 10801741104203 Lot Number: NGKT2496 A304714A / 00801741104268 10801741104265 Lot Number: NGKU2923 A304716A / 00801741104299 10801741104296 Lot Numbers: NGKU1833 NGKU4729 A304718A / 00801741100376¿ 10801741100373 Lot Numbers: NGKT3224 NGKU3971 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A319416A / 00801741100307¿ 10801741100304 Lot Number: NGKS1605 SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter A319416AM / 00801741073861¿ 10801741073868 Lot Numbers: NGKT2390 NGKT2410 NGKT3225 NGKT3319 NGKU0951 NGKU0977 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A319418A / 00801741100314¿ 10801741100311 Lot Number: NGKT2411 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A903316A / 00801741096600¿ 10801741096607 Lot Numbers: NGKT3392 NGKU2020 **** SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care A300414A / 00801741073755 10801741073752 Lot Number: NGKV3524 SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter A319414AM / 00801741073854 10801741073851 Lot Number: NGKV3487 SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter A319418AM / 00801741073878 10801741073875 Lot Number: NGKV4983 SureStep" Foley Tray System Bardex¿ IC Complete Care A903318A / 00801741104657 10801741104654 Lot Number: NGKV2397
- Quantity
- 212580
- Classification
- Class II
- Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08 PEDINTS10 UDI code: 00801741183300¿ 10801741183307 00801741183218¿ 10801741183215 00801741183232 10801741183239 00801741183225¿ 10801741183222 00801741183249 10801741183246 00801741183263¿ 10801741183260 00801741183270¿ 10801741183277 00801741183287¿ 10801741183284 Preamendment REF: INTL14 INTL15 INTL16 INTP14 UDI code: 00801741183164¿ 10801741183161 00801741183171¿ 10801741183178 00801741183188 10801741183185 00801741183294 10801741183291 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
- FDA recall number
- Z-3117-2026
- Codes, lots and dates
- SureStep Intermittent Catheter Tray INTP16 / 00801741183300¿ 10801741183307 Lot Numbers: NGKT3672 NGKU1467 NGKU3559 INTS14 / 00801741183218 10801741183215 Lot Numbers: NGKT2630 NGKT2687 NGKT3636 NGKT3673 NGKU0119 NGKU0134 NGKU1412 NGKU1439 NGKU1494 NGKU2451 NGKU2487 NGKU2510 INTS14C / 00801741183232 10801741183239 Lot Numbers: NGKT2660 NGKU0149 NGKU1468 INTS16 / 00801741183225 10801741183222 Lot Numbers: NGKT2688 NGKT3587 NGKU0135 NGKU2423 INTS16C / 00801741183249 10801741183246 Lot Numbers: NGKT2631 NGKU0120 NGKU1413 PEDINTS06 / 00801741183263¿ 10801741183260 Lot Number: NGKU2452 PEDINTS08 / 00801741183270 10801741183277 Lot Numbers: NGKT3637 NGKU0166 NGKU1495 PEDINTS10 / 00801741183287¿ 10801741183284 Lot Number: NGKT3674 Pre-amendment INTL14 / 00801741183164 10801741183161 Lot Numbers: NGKT3670 NGKU0132 NGKU1491 INTL15 / 00801741183171 10801741183178 Lot Numbers: NGKT2658 NGKT3584 NGKT3609 NGKU0116 NGKU0118 NGKU0133 NGKU0147 NGKU0163 NGKU1411 NGKU1436 NGKU1437 NGKU1465 NGKU1466 NGKU1492 NGKU2421 NGKU2449 NGKU2450 NGKU2485 NGKU2486 NGKU2508 NGKU2509 NGKU4598 NGKU4601 INTL16 / 00801741183188 10801741183185 Lot Number: NGKU3558 INTP14 / 00801741183294 10801741183291 Lot Numbers: NGKT2659 NGKT3585 NGKT3610 NGKT3635 NGKU0148 NGKU1438 NGKU3567
- Quantity
- 391720 units/kits
- Classification
- Class II
- Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 10801741121064 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A304400A UDI code: 00801741073847¿ 10801741073844 SureStep" Foley Tray System Add-A-Foley Catheter REF: A399400 UDI code: 00801741100369¿ 10801741100366 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A399400A UDI code: 00801741073915¿ 10801741073912 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A904400A UDI code: 00801741074097¿ 10801741074094 SureStep Intermittent Catheter Tray REF: INTAAI UDI code: 00801741183317 10801741183314 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
- FDA recall number
- Z-3118-2026
- Codes, lots and dates
- SureStep" Foley Tray System Add-A-Foley Catheter A153200 / 00801741121067¿ 10801741121064 Lot Number: NGKS2397 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter A304400A / 00801741073847¿ 10801741073844 Lot Numbers: NGKU1023 NGKU3043 SureStep" Foley Tray System Add-A-Foley Catheter A399400 / 00801741100369¿ 10801741100366 Lot Number: NGKU2042 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter A399400A / 00801741073915¿ 10801741073912 Lot Numbers: NGKT2456 NGKT3292 NGKU0999 NGKU1026 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter A904400A / 00801741074097¿ 10801741074094 Lot Numbers: NGKT3231 NGKU2051 SureStep Intermittent Catheter Tray INTAAI / 00801741183317 10801741183314 Lot Number: NGKU1409
- Quantity
- 33850 units/kits
- Classification
- Class II
- Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300316AC UDI-DI code: 00801741143250 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A319516AMC UDI-DI code: 00801741143472 SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800366C UDI-DI code: 00801741143571 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray REF: A897514C UDI-DI code: 00801741074011¿ SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray REF: A897516C UDI-DI code: 00801741143595 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray REF: A902114C UDI-DI code: 00801741144325 ***** SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care REF: A300416AC UDI code: 00801741143281 10801741143288 SureStep" Foley Tray System Bardex¿ IC Complete Care REF: A303314AC UDI code: 00801741143304 10801741143301 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care REF: A319514AMC UDI code: 00801741143465 10801741143462 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A800061C UDI code: 00801741144172 10801741144179 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A800065C UDI code: 00801741144202 10801741144209 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A800360C UDI code: 00801741143519 10801741143516 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF:A800361C UDI code: 00801741143526 10801741143523 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A800362C UDI code: 00801741143540 10801741143547 SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800365C UDI code: 00801741143564 10801741143561 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
- FDA recall number
- Z-3119-2026
- Codes, lots and dates
- (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 Lot Number: NGKT2492 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A300316AC / 00801741143250 Lot Number: NGKU2005 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A319516AMC / 00801741143472 Lot Number: NGKT2392 SureStep" Foley Tray System Bard¿ Lubricath Foley A800366C / 00801741143571 Lot Number: NGKT2413 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray A897514C / 00801741074011¿ Lot Number: NGKU0852 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray A897516C / 00801741143595 Lot Number: NGKT2393 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray A902114C / 00801741144325 Lot Number: NGKU0854 **** SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care A300416AC / 00801741143281 10801741143288 Lot Number: NGKX2635 SureStep" Foley Tray System Bardex¿ IC Complete Care A303314AC / 00801741143304 10801741143301 Lot Number: NGKW2895 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care A319514AMC / 00801741143465 10801741143462 Lot Number: NGKV2284 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray A800061C / 00801741144172 10801741144179 Lot Number: NGKV1388 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray A800065C / 00801741144202 10801741144209 Lot Number: NGKW1905 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray A800360C / 00801741143519 10801741143516 Lot Number: NGKV5086 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray A800361C / 00801741143526 10801741143523 Lot Number: NGKX4683 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray A800362C / 00801741143540 10801741143547 Lot Number: NGKW2771 SureStep" Foley Tray System Bard¿ Lubricath Foley A800365C / 00801741143564 10801741143561 Lot Number: NGKW1853
- Quantity
- 364
- Classification
- Class II
Exactly as the agency lists them
Identifiers and details
- FDA event ID
- 98840
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Covington, GA, United States
Why it was recalled
The reason the FDA lists: “Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.”
Where it was sold
Nationwide. Distribution as the FDA records it: “Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WY. The countries of Bahrain, Canada, Costs Rica, Guatemala, Mexico, Saudi Arabia, and United Arab Emirates.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 98840, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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FAQ
About this recall
Is C.R. Bard Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914… recalled?
Yes. C.R. Bard Inc recalled it on June 25, 2026; FDA published it September 16, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
Recalls
More 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.