The Recall Desk

Manufacturer

O&M HALYARD, INC.

8 recalls in our database name O&M HALYARD, INC. as the manufacturing or recalling firm.

What the numbers show

Total
8
Critical
0
Severe
0
Most recent
2026-06-03

Of the 8 recalls from O&M HALYARD, INC. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–8 of 8

  • HighFDA (Devices)·Z-2230-2026·2026-06-03

    Halyard nitrile exam gloves failed chemical permeation performance specifications

    Halyard Purezero Ultraviolet Nitrile Exam Gloves are being recalled because they failed to meet specifications for chemical permeation performance. 452,500 units are affected.

    Product
    Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2520-2025·2025-09-10

    Surgical drape packs recalled because open seals may compromise sterility

    Orthopedic Pack model 88041-12 and Universal Pack model 77165-06 are recalled because the surgical drape packs may have open seals that could compromise sterility. 1,316 units are affected.

    Product
    Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0983-2025·2025-01-29

    HALYARD Laparotomy Surgical Pack Recalled for Additive Residue Contamination

    O&M HALYARD is recalling HALYARD Laparotomy Packs due to elevated residues of anti-block/slip additives found in the sterile packaging. These surgical instruments were distributed nationwide.

    Product
    Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0728-2025·2025-01-01

    O&M Halyard Procedure Masks Recalled for Unmet Bioburden Testing Requirements

    O&M HALYARD is recalling O&M Halyard Procedure Masks (Product Code 47117) nationwide because they do not meet bioburden testing requirements printed on the packaging.

    Product
    O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0729-2025·2025-01-01

    O&M Halyard Surgical Masks Recalled for Failing Bioburden Testing

    O&M Halyard SOFT TOUCH II Surgical Masks (lot AM4119961) are being recalled for not meeting EN 14683 bioburden testing standards printed on the packaging. No illnesses or injuries have been reported.

    Product
    O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1461-2024·2024-04-10

    Halyard surgical hood mislabeled as surgical cap at dispenser

    O&M Halyard is recalling approximately 75,000 surgical hoods mislabeled as surgical caps at the dispenser level.

    Product
    HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2626-2023·2023-09-27

    FLUIDSHIELD 3 N95 Mask Filtration Failure (Lot AM2164811)

    O&M Halyard recalls FLUIDSHIELD 3 N95 masks in orange size small (Lot AM2164811) after one sample failed filtration efficiency testing. The affected masks may not provide adequate respiratory protection.

    Product
    FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0317-2022·2021-12-08

    HALYARD STERLING ZERO Nitrile Exam Gloves Recall for Discoloration and Loss of Elasticity

    O&M Halyard is recalling HALYARD STERLING ZERO nitrile exam gloves in all sizes due to discoloration and loss of elasticity with aging, making the gloves difficult or impossible to don without tearing. Approximately 5.86 million gloves distributed worldwide are affected.

    Product
    HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
    Category
    Medical Device
    Distribution
    Distributed nationwide