Z-2520-2025Class II

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

Name: Z-2520-2025 Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Creator: O&m Halyard Inc
Published: 2025-07-17
License: https://open.fda.gov/license/

O&M Halyard, Inc. / initiated 2025-07-17 / Open, Classified / root cause: manufacturing process

FDA source

O&M HALYARD INC began a recall of Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029 on 2025-07-17. FDA classified it as Class II and gives the reason as "Surgical drape packs may have open seals, which may compromise the sterility of the product". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2520-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-17
Posted: 2025-09-04
Recalling firm: O&M Halyard, Inc.
Product: Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Product code: KKX Drape, Surgical, Antimicrobial
Reason for recall: Surgical drape packs may have open seals, which may compromise the sterility of the product.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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
Quantity in commerce: 1316
Distribution: Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.
Product codes and lots: Model/UDI-DI/Lot(expiration): 88041-12/30680651880414/AC2424601B9(09/02/2029), 77165-06/30680651771651/AC2424902B(09/05/2029)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2520-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2520-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-04

Product code KKX

K083234Class IIKimberly-Clark Kc100 Surgical Drapes, Model Kc 100, Kimberly-Clark Kc100 Surgical Equipment Covers, Model Kc 100Kimberly-Clark Corp. / cleared 2009-03-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)