MediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect
Integra LifeSciences is recalling MediHoney Gel Wound & Burn Dressing Gel (Model 31815) due to potential induction seal defects in the tube packaging. Approximately 12,166 units were distributed worldwide, including throughout the United States and Malaysia.
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 with a potential packaging seal defect, but no reported illnesses or injuries. The hazard is theoretical—an incomplete seal creates a risk of harm, but actual patient harm has not been documented.
Plain-English summary
Integra LifeSciences Corp. is recalling MediHoney Gel Wound & Burn Dressing Gel (Model 31815, Lot Numbers 2328, 2332, and 2333). The product is a moist wound dressing made with 80% medical-grade active Leptospermum honey. It is intended to maintain a moist wound environment and support autolytic debridement.
The recall was initiated because the induction seal on the device tube packaging may not be completely sealed.
Approximately 12,166 units have been distributed worldwide, including throughout the United States and Malaysia. Patients receiving wound care and healthcare providers using this product should verify the lot number.
The recalled product
- Product
- Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney¿ Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with…
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 12,166
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 (4)
- Model/Catalog Number: 31815
- UDI #: 10381780486886
- Lot #s: 2328
- 2332 and 2333
Distribution
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