MediHoney Hydrogel wound dressings recalled for packaging failures
Integra is recalling MediHoney Hydrogel non-adhesive dressings due to packaging failures that could breach the sterile barrier. Approximately 5374 affected units were distributed worldwide.
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: FDA Class II medical device with potential contamination risk due to sterile barrier compromise. No reported illnesses or injuries have been identified. Per the rubric, risk-of-harm products without reported injuries score at maximum 3.
Plain-English summary
Integra LifeSciences Corp. is recalling MediHoney Hydrogel (models 31620 and 31640), a non-adhesive wound dressing containing Leptospermum honey. The recall is due to packaging failures identified in the product that could compromise the sterile barrier.
The affected units were distributed worldwide to healthcare facilities and consumers in the United States, Canada, Australia, New Zealand, Korea, Guam, and Malaysia. Approximately 5374 units are involved in this recall.
Consumers and healthcare providers who have these products should stop using them immediately. Contact Integra LifeSciences Corp. for information about returns and replacements. If you have questions, refer to the FDA recall notice Z-2509-2025.
The recalled product
- Product
- Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel ge
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device — Wound Dressing
- Hazard
- sterile-barrier-breach
- contamination-risk
- packaging-failure
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)
- Model/Catalog Number: (1) 31620
- (2) 31640
- UDIs: (1) 10381780471370
- (2) 10381780471400
- Lot#s: (1) 30623
- 40724
- 25022
- 23823
- 54922
- 24123
- 54322
- 54023
- 23024
- 43823
- 13424
- (2) 24423
- 53424
- 11323
- 51324
- 10823
Distribution
Distributed nationwide across the United States.
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