O & M Halyard, Inc.
7 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (7)
Registered facilities (11)
- Owens & Minor Distribution Inc. OM41 FEI 3010376936 · TX
- AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305 FEI 1047429 · VA
- MEDICAL ACTION INDUSTRIES, INC. 306 FEI 1030451 · NC
- OWENS & MINOR DISTRIBUTION INC.OM05 FEI 3036002406 · WV
- OM HEALTHCARE LOGISTICS OM03 FEI 3008135745 · KY
- OWENS & MINOR DISTRIBUTION INC. OM65 FEI 1000124971 · CA
- ArcRoyal uc FEI 3011144486 · IE
- OWENS & MINOR DISTRIBUTION INC. OM30 FEI 3003924117 · GA
- Owens & Minor Distribution Inc. OM45 FEI 3002669946 · FL
- OWENS & MINOR DISTRIBUTION INC. OM87 FEI 2000028362 · VA
- Owens & Minor Distribution Inc. OM44 FEI 1823410 · MI
Recalls & enforcement
- Class IIOngoing2026-04-13Nitrile Exam Glove failed to meet specifications chemical permeation performance.
- Class IIOngoing2025-07-17Surgical drape packs may have open seals, which may compromise the sterility of the product.
- Class IIOngoing2024-11-26Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
- Class IIOngoing2024-11-08Not 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 IIIOngoing2024-02-20Product was mislabeled as a Surgical Cap at its dispenser level.
- Class IIOngoing2023-08-09One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
- Class IIOngoing2021-09-27All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “O & M Halyard, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10039033-o-m-halyard-inc/
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