Mechanicsville, VA, United States
O&M HALYARD, INC. recalls
7 recalls recorded since 2018, most recently on 13 April 2026. 7 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)7
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 13 April 2026
- Reason
- Nitrile Exam Glove failed to meet specifications chemical permeation performance.
- Distribution
- US Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2230-2026
- Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
Ongoing Class II Medical devices
- Recall started
- 17 July 2025
- Reason
- Surgical drape packs may have open seals, which may compromise the sterility of the product.
- Distribution
- Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2520-2025
- Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Ongoing Class II Medical devices
- Recall started
- 26 November 2024
- Reason
- Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
- Distribution
- US Nationwide distribution in the states of CO, FL, GA, HI, IA, IL, IN, KS, LA, MI, MN, MO, NC, NE, NY, TN, TX, VA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0983-2025
- Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Ongoing Class II Medical devices
- Recall started
- 8 November 2024
- 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 packaging, compliance is required.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0728-2025, Z-0729-2025
- O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
- O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
Ongoing Class III Medical devices
- Recall started
- 20 February 2024
- Reason
- Product was mislabeled as a Surgical Cap at its dispenser level.
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI, MN, MO, MT, SD, TN, TX, and WA. The country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1461-2024
- HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Ongoing Class II Medical devices
- Recall started
- 9 August 2023
- Reason
- One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
- Distribution
- US Distribution to States of: FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI and OUS International to country of: Columbia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2626-2023
- FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
Ongoing Class II Medical devices
- Recall started
- 27 September 2021
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of EU/Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0317-2022
- HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.