O&M HALYARD Recalls
8 recalls on record · December 8, 2021 to June 3, 2026 · Medical Devices
Recalls by year
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24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 3, 2026Medical DevicesFDA
O&M HALYARD INC recalls Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.),
Hazard: Nitrile Exam Glove failed to meet specifications chemical permeation performance.
September 10, 2025Medical DevicesFDA
O&M HALYARD INC recalls Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Hazard: Surgical drape packs may have open seals, which may compromise the sterility of the product.
January 29, 2025Medical DevicesFDA
O&M HALYARD, INC. recalls Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Descript
Hazard: Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
January 1, 2025Medical DevicesFDA
O&M HALYARD, INC. recalls O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
Hazard: 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.
January 1, 2025Medical DevicesFDA
O&M HALYARD, INC. recalls O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Hazard: 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.
April 10, 2024Medical DevicesFDA
O&M HALYARD, INC. recalls HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Hazard: Product was mislabeled as a Surgical Cap at its dispenser level.
September 27, 2023Medical DevicesFDA
O&M HALYARD, INC. recalls FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code
Hazard: One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
December 8, 2021Medical DevicesFDA
O&M HALYARD INC recalls HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
Hazard: All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.