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O&M HALYARD, INC.

Last updated September 17, 2026

Information

Country: US
Address: 1220 Old Alpharetta Rd Ste 320, Alpharetta, GA, 30005
Website: owens-minor.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(844)425-9273
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3014421917
DUNS Number: 081057389

Catalogue (2732)

Page 1 of 55

Device	Model / Reference	Registries	Class	Status
HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap	K253454	FDA 510(k)	Class II	Active
Halyard	89356	FDA UDI	Class II	Active
Halyard	77904	FDA UDI	Class II	Active
Halyard	44177	FDA UDI	Class II	Unknown
Halyard	72454	FDA UDI	Class II	Unknown
Halyard	68018	FDA UDI	Class II	Active
Halyard	37661	FDA UDI	Class I	Unknown
Halyard	78039	FDA UDI	Class II	Active
Halyard	89680	FDA UDI	Class II	Active
Halyard	68248	FDA UDI	Class II	Active
Halyard	89535	FDA UDI	Class II	Active
Halyard	89048	FDA UDI	Class II	Active
Halyard	47622	FDA UDI	Class II	Active
Halyard	34181	FDA UDI	Class II	Active
Halyard	79095	FDA UDI	Class II	Active
Halyard	88888	FDA UDI	Class II	Active
Halyard	48071	FDA UDI	Class II	Active
Halyard	44695	FDA UDI	Class II	Active
Halyard	48898	FDA UDI	Class II	Active
Halyard	45184	FDA UDI	Class II	Active
Halyard	79747	FDA UDI	Class II	Active
Halyard	89674	FDA UDI	Class II	Active
Halyard	02383	FDA UDI	Class II	Active
Halyard	62356	FDA UDI	Class II	Active
Halyard	62484	FDA UDI	Class II	Active
Halyard	95121	FDA UDI	Class II	Active
Halyard	31758	FDA UDI	Class II	Active
Halyard	47095	FDA UDI	Class II	Unknown
Halyard	77065	FDA UDI	Class II	Active
Halyard	47578	FDA UDI	Class II	Active
Halyard	10772	FDA UDI	Class II	Active
Halyard	32573	FDA UDI	Class II	Active
Halyard	62360	FDA UDI	Class II	Unknown
Halyard	85631	FDA UDI	Class I	Active
Halyard	10045	FDA UDI	Class I	Active
Halyard	29225	FDA UDI	Class II	Active
Halyard	10157	FDA UDI	Class I	Active
Halyard	47753	FDA UDI	Class II	Active
Halyard	89751	FDA UDI	Class II	Active
Halyard	69190	FDA UDI	Class I	Active
Halyard	49441	FDA UDI	Class I	Active
Halyard	10034	FDA UDI	Class I	Active
Halyard	25868	FDA UDI	Class II	Active
Halyard	89233	FDA UDI	Class II	Active
Halyard	77472	FDA UDI	Class II	Active
Halyard	01487	FDA UDI	Class II	Active
Halyard	34158	FDA UDI	Class II	Active
Halyard	02437	FDA UDI	Class II	Active
Halyard	44257	FDA UDI	Class II	Active
Halyard	62072	FDA UDI	Class II	Unknown

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FDA Recalls (8)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 13, 2026	Z-2230-2026	—	open, classified	Nitrile Exam Glove failed to meet specifications chemical permeation performance.
Jul 17, 2025	Z-2520-2025	—	open, classified	Surgical drape packs may have open seals, which may compromise the sterility of the product.
Nov 26, 2024	Z-0983-2025	—	open, classified	Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Nov 8, 2024	Z-0729-2025	—	open, classified	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.
Nov 8, 2024	Z-0728-2025	—	open, classified	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.
Feb 20, 2024	Z-1461-2024	—	open, classified	Product was mislabeled as a Surgical Cap at its dispenser level.
Aug 9, 2023	Z-2626-2023	—	open, classified	One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
Sep 27, 2021	Z-0317-2022	—	open, classified	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.