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O&M Halyard Inc FDA Recalls
8 recalls on file across devices, 0 of them Class I and 8 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), Class IIApr 13, 2026Nitrile Exam Glove failed to meet specifications chemical p |
| Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029Class IIJul 17, 2025Surgical drape packs may have open seals, which may compromi |
| Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product DescriptClass IINov 26, 2024Elevated residues of anti-block/slip additive used in manufa |
| O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500Class IINov 8, 2024Not meeting the bioburden testing requirements of EN 14683 r |
| O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117Class IINov 8, 2024Not meeting the bioburden testing requirements of EN 14683 r |
| HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)Class IIIFeb 20, 2024Product was mislabeled as a Surgical Cap at its dispenser le |
| FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product CodeClass IIAug 9, 2023One respirator sample failed a filtration efficiency test. T |
| HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XLClass IISep 27, 2021All lots of the glove may discolor and lose elasticity upon |