CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report

Manuka Honey Wound Gel recalled by Integra LifeSciences

Integra LifeSciences is recalling Manuka Honey Wound Gel, distributed in Rhode Island. The recall was initiated on 6 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot# 1610; 1621; 1639; 1737; 1745
Quantity recalled766 cases

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1630-2018
FDA event ID
79765
Recalling firm
Integra LifeSciences, Plainsboro, NJ
Classification
Class II
Status
Terminated
Recall initiated
6 Mar 2018
FDA classified
4 May 2018
Reported
16 May 2018
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

6 Mar 2018Recall initiated by company
4 May 2018Classified by FDA+59 days
16 May 2018Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect gel part number listed in a master manufacturing record

Product as listed by the FDA

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

Where it was distributed

US state of RI

Rhode Island

Questions about this recall

Is Manuka Honey Wound Gel recalled?

Yes. Integra LifeSciences recalled Manuka Honey Wound Gel on 6 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1630-2018.

Why was it recalled?

Incorrect gel part number listed in a master manufacturing record

Which lots are affected?

Lot# 1610; 1621; 1639; 1737; 1745

Where was it sold?

US state of RI

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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