Halyard, Pain Pack. Kit Code: AMPK48-01 recallZ-2407-2026 · AVID Medical, Inc. · initiated Apr 30, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from AVID Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
FDA root cause category: Process control
What the company is doing
AVID Medical notified consignees on about 04/30/2026 via emailed letter. Consignees were instructed to identify, segregate and quarantine all affected units on hand, discard all impacted kits and complete and return the provided Response Form. Distributors were instructed to ensure all end-users are appropriately notified and maintain records of effectiveness.
Recall details
- Recall number
- Z-2407-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 30, 2026
- Posted by the FDA
- Jun 11, 2026
- Recalling firm
- AVID Medical, Inc.
- Quantity
- 120 kits
- Product code
- OJH
- Distribution
- US Nationwide distribution in the state of Iowa.
Product description
Halyard, Pain Pack. Kit Code: AMPK48-01.
Code information (models, lots, serial numbers)
Kit Code: AMPK48-01. UDI-DI: 10809160472798. Lot Number: 334669. Expiration Date: 8/27/2028.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Halyard AMPK48-01Avid Medical, Inc. · Orthopedic tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99021).
- Z-2408-2026 · Open, ClassifiedHalyard, Towel Six Pack. Kit Code: AMTS70-01.
- Z-2409-2026 · Open, ClassifiedHalyard, Drape Pack. Kit Code: LMDP36-01.
- Z-2410-2026 · Open, ClassifiedHalyard, Eye Bag Pack. Kit Code: UIEB48-01.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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