AVID Medical recall: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK and 1 more product
AVID Medical, Inc. is recalling DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK and 1 more product – 45 kits; 63 kits; 78 kits; 120 Kits; 130 KITS. The U.S. Food and Drug Administration published the recall on September 2, 2026; it began on July 9, 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 | DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK and 1 more product |
| Brand | AVID Medical |
| Company | AVID Medical, Inc. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 9, 2026 |
| Published by FDA | September 2, 2026 |
| Quantity | 45 kits; 63 kits; 78 kits; 120 Kits; 130 KITS |
| Recall ID | 99527 |
Recalled products (7)
- Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
- FDA recall number
- Z-3005-2026
- Codes, lots and dates
- Lot Code: Lot Number: 1634391 UDI: 10809160439708
- Quantity
- 45 kits
- Classification
- Class II
- Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- FDA recall number
- Z-3006-2026
- Codes, lots and dates
- Lot Code: Lot Number: 1632948 UDI: 10809160423578
- Quantity
- 63 kits
- Classification
- Class II
- Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- FDA recall number
- Z-3007-2026
- Codes, lots and dates
- Lot Code: Lot Number: 1649979 UDI: 10809160457887
- Quantity
- 78 kits
- Classification
- Class II
- Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- FDA recall number
- Z-3008-2026
- Codes, lots and dates
- Lot Code: Lot Number: 1654575 UDI: 10809160457887
- Quantity
- 78 kits
- Classification
- Class II
- Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- FDA recall number
- Z-3009-2026
- Codes, lots and dates
- Lot Code: Lot Number: 1662335 UDI: 10809160457887
- Quantity
- 120 Kits
- Classification
- Class II
- Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- FDA recall number
- Z-3010-2026
- Codes, lots and dates
- Lot Code: Lot Number: 1673233 UDI: 10809160457887
- Quantity
- 130 KITS
- Classification
- Class II
- Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- FDA recall number
- Z-3011-2026
- Codes, lots and dates
- Lot Code: Lot Number: 1649519 UDI: 10809160457887
- Quantity
- 78 kits
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99527
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Toano, VA, United States
Why it was recalled
The reason the FDA lists: “Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.”
Where it was sold
Nationwide. Distribution as the FDA records it: “US Nationwide distribution in the states of MS, TX.”
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 99527, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other AVID Medical recalls
| 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 9, 2026 | AVID Medical recall: Halyard medical convenience kits labeled as: 1) ENT and 2 more productsMedical devices · 11763 kits; 16223 kits; 816 kits | a sterility problem 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 |
About this recall
Is AVID Medical DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK recalled?
Yes. AVID Medical, Inc. recalled it on July 9, 2026; FDA published it September 2, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
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.
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.