Integra Manuka Honey Wound Gel Recalled for Incorrect Manufacturing Record
Integra LifeSciences Corp. is recalling Manuka Honey Wound Gel due to an incorrect part number listed in a master manufacturing record.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a documentation error (incorrect part number in a master manufacturing record) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Integra LifeSciences Corp. is recalling 766 cases of Manuka Honey Wound Gel (Catalogue No: 716597). The product is used to help maintain a moist wound environment for minor scalds, burns, cuts, lacerations, and abrasions.
The recall was initiated because an incorrect gel part number was listed in a master manufacturing record. The affected lots are 1610, 1621, 1639, 1737, and 1745. The product was distributed in the US state of Rhode Island.
Consumers who have this product should stop using it and contact the manufacturer for further instructions.
The recalled product
- Product
- Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions
- Manufacturer
- Integra LifeSciences Corp.
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 766
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 (5)
- Lot# 1610
- 1621
- 1639
- 1737
- 1745
Distribution
Distributed in 1 state:
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