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Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 recallZ-2520-2025 · O&M Halyard Inc · initiated Jul 17, 2025

Open, Classified

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from O&M Halyard Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

Surgical drape packs may have open seals, which may compromise the sterility of the product.

FDA root cause category: Process control

What the company is doing

On 7/17/2025, Field Action Customer Notifications were emailed to customers who were asked to do the following: 1) DESTROY or DISCARD the product available in your inventory per the facility's standard disposal procedure for surgical packs. 2) COMMUNICATE this Field Action to staff to ensure awareness of it. 3) If any of the affected lot identified above was further distributed, please ensure all end-users are appropriately notified of this Field Action and maintain records of effectiveness. 4) Any adverse events associated with the use of the affected product should be reported to [email protected]. 5) RETURN the completed Field Action Response Form to [email protected] as soon as possible even if you have no current product inventory. 6) If credit is requested, please get contact with the Customer Service team and send email to [email protected]. If you have any questions, please email [email protected] using the Event # FA-2025-015 in the header of the response

Recall details

Recall number
Z-2520-2025
Status
Open, Classified
Initiated by the company
Jul 17, 2025
Posted by the FDA
Sep 4, 2025
Recalling firm
O&M Halyard Inc
Quantity
1316
Product code
KKX
FDA submissions
K083234
Distribution
Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.

Product description

Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029

Code information (models, lots, serial numbers)

Model/UDI-DI/Lot(expiration): 88041-12/30680651880414/AC2424601B9(09/02/2029), 77165-06/30680651771651/AC2424902B(09/05/2029)

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

7 devices cleared under K083234 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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