Facility

OM HEALTHCARE LOGISTICS OM03

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

Key facts

7recalls · worst Class II

3inspections · 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)	3008135745
Establishment type	Repack or Relabel Medical Device
Location	6201 Global Distribution Way Ste 101 Louisville, KY, US 40228
Registration status	Active · expires 2026
Parent company	O & M Halyard, Inc. (owner-operator 10039033)

Activity by year

Recalls (7)
Inspections (3)

Devices registered here (1)

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Product code KCT (opens in a new tab) · Class II · General Hospital · 21 CFR 880.6850

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 (3)

NAI2025-02-12
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2016-09-22
No Action Indicated · Compliance: Devices
NAI2016-05-12
No Action Indicated · Compliance: 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. “OM HEALTHCARE LOGISTICS OM03 (FEI 3008135745) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008135745-om-healthcare-logistics-om03/

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