O And M Halyard recalls
O And M Halyard appears in 8 official U.S. recall notices indexed by RecallRadar, most recently on 2026-06-03.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 8 |
|---|---|
| Published | 2021-12-08 to 2026-06-03 |
| By agency | FDA Device (8) |
| By classification | Class II (7), Class III (1) |
| By status | ongoing (8) |
| Distribution named in notices | FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, US, WI |
Recalls
- Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
FDA Device · Class II · 2026-06-03 · O And M Halyard
Reason: Nitrile Exam Glove failed to meet specifications chemical permeation performance. - Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
FDA Device · Class II · 2025-09-10 · O And M Halyard
Reason: Surgical drape packs may have open seals, which may compromise the sterility of the product. - Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Co…
FDA Device · Class II · 2025-01-29 · O And M Halyard
Reason: Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging. - O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
FDA Device · Class II · 2025-01-01 · O And M Halyard
Reason: 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 packa… - O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
FDA Device · Class II · 2025-01-01 · O And M Halyard
Reason: 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 packa… - HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
FDA Device · Class III · 2024-04-10 · O And M Halyard
Reason: Product was mislabeled as a Surgical Cap at its dispenser level. - FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
FDA Device · Class II · 2023-09-27 · O And M Halyard
Reason: One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user. - HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
FDA Device · Class II · 2021-12-08 · O And M Halyard
Reason: 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.