O&M HALYARD, INC.
5 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for O&M HALYARD, INC. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-09-10FDA-DeviceClass IIOrthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Surgical drape packs may have open seals, which may compromise the sterility of the product.
- 2025-01-29FDA-DeviceClass IIBrand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
- 2025-01-01FDA-DeviceClass IIO&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
- 2025-01-01FDA-DeviceClass IIO&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
- 2024-04-10FDA-DeviceClass IIIHALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Product was mislabeled as a Surgical Cap at its dispenser level.
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