Medline Esmark Elastic Bandages Recalled for Sterilization Failure
Medline Industries is recalling 2,860 Esmark Elastic Bandages because they may not have been properly sterilized.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a medical device that may be non-sterile, posing a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries Inc. is recalling 2,860 units of Esmark Elastic Bandage (Sterile), 4" x 9' (Item DYNJ05116A, Lot 13LA1009). The recall was initiated because the specific lot did not undergo the correct sterilization procedures, meaning the products may potentially be non-sterile.
The affected bandages were distributed nationwide, including in Arizona, California, Iowa, Illinois, Indiana, Kentucky, Louisiana, Michigan, Mississippi, New Jersey, New York, Ohio, Pennsylvania, Texas, and Washington. These products are used to support and compress parts of a patient's body or as a tourniquet to restrict blood flow.
Consumers and healthcare facilities should stop using the affected bandages and contact Medline Industries for further instructions or a refund.
The recalled product
- Product
- Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medline Industries Inc. This product is used as an elastic bandage to support and compress a part of a patient's body. It is also used as a tourniquet to restrict…
- Manufacturer
- Medline Industries Inc
- Affected units
- 2,860
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 (1)
- Product Number: DYNJ05116A . Lot Number: 13LA1009.
Distribution
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