O&M HALYARD INC Recalls

6 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (6)

April 13, 2026
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
Nitrile Exam Glove failed to meet specifications chemical permeation performance.
Class II
July 17, 2025
Orthopedic 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.
Class II
November 26, 2024
Brand 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.
Class II
November 8, 2024
O&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.
Class II
November 8, 2024
O&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.
Class II
February 20, 2024
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Product was mislabeled as a Surgical Cap at its dispenser level.
Class III

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