RecallRadar

FDA Device recall Z-2520-2025

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

On 2025-09-10 the FDA classified a Class II recall of Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029 by O And M Halyard, citing surgical drape packs may have open seals, which may compromise the sterility of the product.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2520-2025
ClassificationClass II
Statusongoing
Initiated2025-07-17
Published2025-09-10
Last updated2026-09-13 11:57 UTC
CompanyO And M Halyard
DistributionUS

Product

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

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2520-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.