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MEDICAL DEVICE RECALLMODERATE
Halyard Pain Pack
AVID Medical recalls Halyard Pain Pack kits (AMPK48-01) over possible lack of sterilization.
What to do
Do not use the affected Halyard Pain Pack kits. Contact AVID Medical, Inc. for instructions on returning the product and obtaining a replacement.
Why it was recalled
AVID Medical, Inc. is recalling Halyard Pain Pack kits with Kit Code AMPK48-01 because sealed pouches may have been distributed without undergoing validated sterilization, posing a risk of infection.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Lot code | Recall # | UDI-DI |
|---|---|---|---|
| Halyard, Towel Six Pack. Kit Code: AMTS70-01. | AMTS70-01, 2028 | Z-2408-2026 | 10809160469972 |
| Halyard, Pain Pack. Kit Code: AMPK48-01. | 334669, 2028 | Z-2407-2026 | 10809160472798 |
| Halyard, Drape Pack. Kit Code: LMDP36-01. | LMDP36-01, 2028 | Z-2409-2026 | 10809160479148 |
| Halyard, Eye Bag Pack. Kit Code: UIEB48-01. | UIEB48-01, 2028 | Z-2410-2026 | 10809160484098 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Sterility Failure recalls
Other recent recalls from AVID Medical, Inc.
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification
