Facility

Owens & Minor Distribution Inc. OM41

7 recall(s) on record — most severe on record: Class II.

Key facts

7recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3010376936
Establishment type	Repack or Relabel Medical Device
Location	550 Lakeside Pkwy Flower Mound, TX, US 75028
Registration status	Active · expires 2026
Parent company	O & M Halyard, Inc. (owner-operator 10039033)
Brand names	SurgiTrack; Knee Pack; General Surgery Tray (Kit); Hand Pack; Hip Pack; Toe Nail Kit; General Convenience Kit; General Purpose Kit

Activity by year

Recalls (7)
Inspections (1)

Devices registered here (1)

General Surgery Tray
Product code LRO (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4370

Recalls & enforcement

Class IIOngoing2026-04-13
Nitrile Exam Glove failed to meet specifications chemical permeation performance.
Class IIOngoing2025-07-17
Surgical drape packs may have open seals, which may compromise the sterility of the product.
Class IIOngoing2024-11-26
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Class IIOngoing2024-11-08
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 IIIOngoing2024-02-20
Product was mislabeled as a Surgical Cap at its dispenser level.
Class IIOngoing2023-08-09
One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
Class IIOngoing2021-09-27
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.

FDA inspections (1)

NAI2019-11-14
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Owens & Minor Distribution Inc. OM41 (FEI 3010376936) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010376936-owens-minor-distribution-inc-om41/

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