Z-1630-2018Class II

Manuka Honey Wound Gel Catalogue No: 716597

Name: Z-1630-2018 Manuka Honey Wound Gel Catalogue No: 716597
Creator: Integra LifeSciences Corp.
Published: 2018-03-06
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2018-03-06 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of 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... on 2018-03-06. FDA classified it as Class II and gives the reason as "Incorrect gel part number listed in a master manufacturing record". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1630-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-06
Posted: 2018-05-04
Terminated: 2018-07-30
Recalling firm: Integra LifeSciences Corporation
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
Product code: FRO Dressing, Wound, Drug
Reason for recall: Incorrect gel part number listed in a master manufacturing record
Root cause tag: manufacturing process
FDA root cause: Manufacturing material removal
Action: Integra sent an Urgent Voluntary Medical Device Recall letter dated March, 6th, 2018 to distributor. The letter identified the affected product problem and actions to be taken. The letter instruct to complete and return the recall Acknowledgement form. For questions contact Customer Service at 1-800-854-2873. .
Quantity in commerce: 766 cases
Distribution: US state of RI
Product codes and lots: Lot# 1610; 1621; 1639; 1737; 1745

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1630-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1630-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04

Product code FRO

K101793UnclassifiedMedihoney Gel Dressing with Active Manuka HoneyDerma Sciences, Inc. / cleared 2011-02-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)