Halyard, CPT BASIC IR PACK. Model Number: 1646381 recallZ-2531-2025 · AVID Medical, Inc. · initiated Aug 4, 2025
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
Potential for open header bag seals, compromising sterility.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Owens & Minor notified consignees on about 08/04/2025 via email. Consignees were instructed to discard and discontinue use of all impacted kits. to notify customers if affected units were further distributed, and complete and return the Recall Response Form provided.
Recall details
- Recall number
- Z-2531-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 4, 2025
- Posted by the FDA
- Sep 5, 2025
- Recalling firm
- AVID Medical, Inc.
- Quantity
- 228 units
- Product code
- LRO
- Distribution
- US Nationwide distribution in the state of Florida.
Product description
Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.
Code information (models, lots, serial numbers)
Model Number: 1646381. UDI: 10809160363256. Lot Number: 1646381. Expiration Date: 1/31/2028.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Halyard SHAN436-02_0001Avid Medical, Inc. · General surgery tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97452).
- Z-2530-2025 · Open, ClassifiedHalyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
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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