FDAJuly 17, 2025device
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Surgical drape packs may have open seals, which may compromise the sterility of the product.
What to do
FDA enforcement status: Ongoing
Brands named
o m halyard
UPCs
3068065188041430680651771651
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAHalyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)2026-04-13
- FDABrand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A2024-11-26
- FDAO&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 471172024-11-08
- FDAO&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 475002024-11-08
- FDAHALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)2024-02-20
- FDAFLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 468272023-08-09
- FDAHALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL2021-09-27
- FDAHalyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as the following: a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE); b. HALYARD* 12 FR TRACH CARE DSE ENDO; c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE); d. HALYAR...2018-02-07
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