Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps… — Class II medical device recall Z-1630-2018
Terminated recall by Integra LifeSciences Corp., reported 2018-05-16, distributed in RI. Incorrect gel part number listed in a master manufacturing record
| Recall number | Z-1630-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2018-03-06 |
| Classified | 2018-05-04 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2018-07-30 |
| Distributed | RI |
| Quantity | 766 cases |
| Lot numbers | 1610, 1621, 1639, 1737, 1745 |
| Model numbers | 716597 |
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
Reason for recall
Incorrect gel part number listed in a master manufacturing record
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1630-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.