CLASS II ONGOING Device recall · Reported 19 Feb 2025 · FDA Enforcement Report

MediHoney¿ Gel MediHoney¿ Wound & Burn Dressing Gel recalled

Integra LifeSciences is recalling MediHoney¿ Gel MediHoney¿ Wound & Burn Dressing Gel, distributed nationwide in the US. The recall was initiated on 10 Jan 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog Number: 31815; UDI #: 10381780486886; Lot #s: 2328, 2332 and 2333;
Quantity recalled12,166 units

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-1168-2025
FDA event ID
96109
Recalling firm
Integra LifeSciences, Princeton, NJ
Classification
Class II
Status
Ongoing
Recall initiated
10 Jan 2025
FDA classified
12 Feb 2025
Reported
19 Feb 2025
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Packaging Defects
Device type
Medical Software

Timeline

10 Jan 2025Recall initiated by company
12 Feb 2025Classified by FDA+33 days
19 Feb 2025Published in enforcement report+7 days

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

Reason for recall

Potential that the induction seal is not completely sealed to the device tube packaging.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney¿ Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with gelling agents. The gelling agents act to maintain the physical integrity and viscosity of the dressing upon application. As a percentage of the overall dressing, MediHoney Gel dressing contains 80% medical grade honey by weight. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used. Component: No

Where it was distributed

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY and the Virgin Islands and the country of Malaysia.

Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoDelawareFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichigan

Questions about this recall

Why was it recalled?

Potential that the induction seal is not completely sealed to the device tube packaging.

Which lots are affected?

Model/Catalog Number: 31815; UDI #: 10381780486886; Lot #s: 2328, 2332 and 2333;

Where was it sold?

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY and the Virgin Islands and the country of Malaysia.

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 26 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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