The Recall Desk
HighFDA (Devices)·Z-0734-2016·Announced 2016-02-10

Owens & Minor Recalls MediChoice Cohesive Bandages Due to Microbial Contamination

Owens & Minor is recalling MediChoice sterile cohesive bandages because testing revealed microbial contamination. The affected bandages were distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves microbial contamination, which poses a risk of harm without reported illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Owens & Minor Distribution, Inc. is recalling MediChoice sterile cohesive bandages. The recall was initiated after testing indicated that the bandages were contaminated with microorganisms. The product is described as one roll of cohesive bandage per bag, with thirty-six bags per case, intended for general hospital use.

The recall covers 96,266 units of the product. The bandages were distributed nationwide. Specific lot numbers and expiration dates are listed in the official recall notice, ranging from April 2016 to July 2018.

Consumers and healthcare facilities should stop using the affected bandages and contact Owens & Minor for instructions on how to return or dispose of the product. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.
Manufacturer
Owens & Minor Distribution, Inc.
Category
Medical Device — Wound Care
Hazard
Affected units
96,266

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Item No. Lot No. Expiration Date: CBN1104 15023H09A Jan-18
  • CBN1104 15033H09A Feb-18
  • CBN1104 15043H09A Mar-18
  • CBN1104 15053H09A Apr-18
  • CBN1104 15063H09A May-18
  • CBN1104 15073H09A Jun-18
  • CBN1104 15083H09A Jul-18
  • CBN1104 14113H09A Oct-17
  • CBN1104 14123H09A Nov-17
  • CBN1104 15013H09A Dec-17
  • CBN1104 14063H09A May-17
  • CBN1104 14083H09A Jul-17
  • CBN1104 14093H09A Aug-17
  • CBN1104 14053H09A Apr-17
  • CBN1104 14043H09A Mar-17
  • CBN1104 14013H09A Dec-16
  • CBN1104 13053H09A Apr-16
  • CBN1104 12113H09A Oct-15
  • CBN1104 13033H09A Feb-16
  • CBN1104 13083H09A Jul-16

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Owens & Minor Distribution, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Owens & Minor Distribution, Inc.

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Same hazard · microbial contamination

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