--- title: "O&M HALYARD, INC. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search O&M HALYARD, INC. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/o-m-halyard-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # O&M HALYARD, INC. recall records **7** reported ongoing 7 records in this archive. Latest source date Apr 13, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Apr 13, 2026 FDA device enforcement ### [Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)](https://isitonrecall.com/recall/fda-device-z-2230-2026-halyard-purezero-ultraviolet-nitrile-exam-gloves-reference-numbers-48771-xs-48772-sm-48773-md-48774/) Nitrile Exam Glove failed to meet specifications chemical permeation performance. Class II Reported ongoing Distribution: US Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC. [Official source for Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 4877...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2230-2026%22) Jul 17, 2025 FDA device enforcement ### [Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029](https://isitonrecall.com/recall/fda-device-z-2520-2025-orthopedic-pack-model-88041-12-ac2424601b-09-02-2029-universal-pack-model-77165-06-ac2424902b-09-05/) Surgical drape packs may have open seals, which may compromise the sterility of the product. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX. [Official source for Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2520-2025%22) Nov 26, 2024 FDA device enforcement ### [Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A](https://isitonrecall.com/recall/fda-device-z-0983-2025-brand-name-halyard-product-name-laparotomy-pack-model-catalog-number-88231-software-version-n-a-prod/) Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging. Class II Reported ongoing 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. [Official source for Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0983-2025%22) Nov 8, 2024 FDA device enforcement ### [O&M Halyard Procedure Mask with SO SOFT\* Earloops, Yellow-Disposable surgical mask Product Code: 47117](https://isitonrecall.com/recall/fda-device-z-0728-2025-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 Reported ongoing Distribution: Nationwide [Official source for O&M Halyard Procedure Mask with SO SOFT\* Earloops, Yellow-Disposable surgical mask Product Code: ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0728-2025%22) Nov 8, 2024 FDA device enforcement ### [O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500](https://isitonrecall.com/recall/fda-device-z-0729-2025-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 Reported ongoing Distribution: Nationwide [Official source for O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0729-2025%22) Feb 20, 2024 FDA device enforcement ### [HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)](https://isitonrecall.com/recall/fda-device-z-1461-2024-halyard-surgical-hood-universal-size-blue-300-count-3-x-100/) Product was mislabeled as a Surgical Cap at its dispenser level. Class III Reported ongoing 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. [Official source for HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1461-2024%22) Aug 9, 2023 FDA device enforcement ### [FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT\* Lining, Orange, size small, Product Code 46827](https://isitonrecall.com/recall/fda-device-z-2626-2023-fluidshield-3-n95-particulate-filter-respirator-and-surgical-mask-with-so-soft-lining-orange-size-sm/) One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user. Class II Reported ongoing Distribution: US Distribution to States of: FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI and OUS International to country of: Columbia [Official source for FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT\* Lining, Orange, s...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2626-2023%22) ## Reasons in these listed records - Nitrile Exam Glove failed to meet specifications chemical permeation performance. - Surgical drape packs may have open seals, which may compromise the sterility of the product. - Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging. - 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. These examples come from this result page and are not a ranking of every recall reason. ## Checking O&M HALYARD, INC. ### Is there a recall on o&m halyard, inc. right now? This archive contains 7 records, including 7 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search O&M HALYARD, INC.](https://isitonrecall.com/check/?q=O%26M%20HALYARD%2C%20INC.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)