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Lower risk Medical device recall · FDA · Published March 6, 2018

Integra Manuka Honey Wound Gel Recall: Incorrect Part Number Listed in Records

Integra LifeSciences recalls Manuka Honey Wound Gel (Catalogue No: 716:597) due to an incorrect gel part number in manufacturing records. This may affect wound healing for minor injuries.

🇺🇸 FDA recall #Z-1630-2018Medical deviceIntegra LifeSciences ›
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Contact the company

Recalling firmIntegra LifeSciences Corp.311 Enterprise Dr · Plainsboro, NJ 08536-3344
✎ GovInfoNow plain-language explainer

Integra LifeSciences is recalling Manuka Honey Wound Gel (Catalogue No: 716597) because an incorrect gel part number was listed in a master manufacturing record. This could potentially impact wound healing for minor injuries like cuts and burns. Read more at govinfonow.com/recall/71768-integra-manuka-honey-wound-gel-recall-incorrect-part-number-listed.

Source Summary by GovInfoNow · govinfonow.com/recall/71768-integra-manuka-honey-wound-gel-recall-incorrect-part-number-listed · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1630-2018

Cite this page

“Integra Manuka Honey Wound Gel Recall: Incorrect Part Number Listed in Records.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71768-integra-manuka-honey-wound-gel-recall-incorrect-part-number-listed. Based on FDA recall #Z-1630-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1630-2018%22&limit=1).

Integra LifeSciences Corp. recalled Manuka Honey Wound Gel (Catalogue No. 716597) because an incorrect gel part number was listed in a master manufacturing record, the FDA said on March 6, 2018.

How to tell if you have it

  • Brand: Integra LifeSciences
  • Product: Manuka Honey Wound Gel
  • Catalogue No.: 716597
  • Lot codes: 1610; 1621; 1639; 1737; 1745
  • Distribution: Rhode Island

The hazard

The recall stems from an incorrect gel part number listed in a master manufacturing record. The product is intended to help maintain a moist wound environment for minor scalds, burns, cuts, lacerations, and abrasions.

Context

GovInfoNow's records show Integra LifeSciences Corp. has 35 other recalls on record since August 18, 2017. Recent brand recalls include the AURORA Surgiscope System (February 6, 2025), MediHoney Wound Dressing Gel (January 10, 2025), and CODMAN CERTAS Plus Valve (December 16, 2024). Other recent recalls of similar products include the MediHoney Gel Dressing (January 16, 2026), Integra CVS Wound Dressing (January 16, 2026), and MEDIHONEY Calcium Alginate Dressing (January 16, 2026).

How to tell if you have this one

Check for Catalogue No: 716597 on the product label. The gel is used for minor scalds, burns, cuts, and abrasions with specific lot numbers: 1610, 1621, 1639, 1737, 1745.

  • Brand
    Integra LifeSciences
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for Catalogue No: 716597 on the product label to confirm if it is recalled.

Where it went and when

Where it was distributed

Distributed in Rhode Island.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: yesRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “US state of RI” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Rhode Island.

Recall timeline

FDA terminated this recall 5 months after the firm started it.

1. Firm started the recall: Mar 6, 201812. FDA classified it Class II: May 4, 201823. Published in FDA’s Enforcement Report: May 16, 201834. FDA terminated the recall: Jul 30, 201842018
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

Yes, the product is safe for use as intended for minor wounds, but the recall is due to a manufacturing record error, not a safety issue.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1630-2018 (March 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1630-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA