MEDIHONEY Dressing Applicator Pouch Recalled for Sterility Concerns
Integra LifeSciences recalls MEDIHONEY Dressing applicator pouches due to potential pinholes that may compromise sterility. The recall affects approximately 120,124 units distributed across 36 US states and internationally.
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: FDA Class II medical device recall with a potential sterility hazard due to pinholes in the applicator film. No illnesses or injuries have been reported; the hazard is theoretical. This meets the rubric criteria for High (3): risk-of-harm products where injury has not yet been reported.
Plain-English summary
Integra LifeSciences Corp. is recalling MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing with Applicator in 1.5oz (Model 31515) and 3.5oz (Model 31535) sizes. The recall is due to a potential for pinholes in the applicator pouch film that creates a sterility concern.
Approximately 120,124 units have been distributed nationwide across 36 US states and internationally to Madagascar, Malaysia, and Guam. All lots distributed from December 17, 2020 through July 22, 2024 are included in the recall, with expiration dates ranging from August 1, 2024 to June 1, 2028.
The recalled product
- Product
- MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 120,124
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 (2)
- Model 31515 UDI-DI: 10381780486824
- Model 31535 UDI-DI: 10381780486831
Distribution
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