CLASS II ONGOING Device recall · Reported 25 Feb 2026 · FDA Enforcement Report

MediHoney Gel with Active Leptospermum Honey recalled

Integra LifeSciences Corp. (NeuroSciences) is recalling MediHoney Gel with Active Leptospermum Honey, distributed nationwide in the US. The recall was initiated on 16 Jan 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. Model Number: 31805; UDI-DI: 10381780486978; Serial numbers: 2405, 2406, 2407, 2408, 2409, 2410, 2418, 2419, 2421, 2422, 2432, 2433, 2513, 2514, 2515. 2. Model Numbers: 31815; UDI-DI: 10381780486886; Lot Numbers: 2407, 2408, 2419, 2425, 2429, 2430, 2442, 2443, 2444, 2445, 2446, 2449, 2450, 2502, 2513, 2515, 2516.

Quantity recalled49,367 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-1363-2026
FDA event ID: 98175
Recalling firm: Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 16 Jan 2026
FDA classified: 13 Feb 2026
Reported: 25 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Other Medical Devices

Timeline

16 Jan 2026	Recall initiated by company
13 Feb 2026	Classified by FDA	+28 days
25 Feb 2026	Published 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

Potential packaging failures, which could lead to a breach in the sterile barrier.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds.

Where it was distributed

Worldwide - US Nationwide distribution in the states of TX, MI, FL, IN, MO, CA, VA, NJ, PA, SC, TN, RI, NY and the countries of Australia, Austria, Bahrain, Canada, Finland, France, Germany, Greece, Guam, Guernsey, Hungary, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Korea (the Republic of), Kuwait, Lebanon, Madagascar, Malaysia, Netherlands (the), New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, Tunisia, Uganda, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the), Virgin Islands (U.S.).

Nationwide California Florida Indiana Michigan Missouri New Jersey New York Pennsylvania Rhode Island South Carolina Tennessee Texas Virginia

Questions about this recall

Why was it recalled?

Potential packaging failures, which could lead to a breach in the sterile barrier.

Which lots are affected?

1. Model Number: 31805; UDI-DI: 10381780486978; Serial numbers: 2405, 2406, 2407, 2408, 2409, 2410, 2418, 2419, 2421, 2422, 2432, 2433, 2513, 2514, 2515. 2. Model Numbers: 31815; UDI-DI: 10381780486886; Lot Numbers: 2407, 2408, 2419, 2425, 2429, 2430, 2442, 2443, 2444, 2445, 2446, 2449, 2450, 2502, 2513, 2515, 2516.

Where was it sold?

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.

Other products in this recall event

2 other products · FDA event 98175

Reported	Class	Recall	Company	Reason	Where
25 Feb 2026	CLASS II	Private Label CVS recalled by Integra LifeSciences Corp.	Integra LifeSciences Corp. (NeuroSciences)	Sterility	Nationwide
25 Feb 2026	CLASS II	Medihoney Calcium Alginate With Active Leptospermum Honey recalled	Integra LifeSciences Corp. (NeuroSciences)	Sterility	Nationwide

More recalls from Integra LifeSciences Corp. (NeuroSciences)

All 31

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	OmniTract Surgical Retractor System recalled	Integra LifeSciences Corp. (NeuroSciences)	Sterility	Nationwide
20 May 2026Device	CLASS II	Codman CerebroFlo EVD Catheter with Endexo Technology recalled	Integra LifeSciences Corp. (NeuroSciences)	Other	Nationwide
29 Apr 2026Device	CLASS II	CUSA Clarity C7000 Console recalled by Integra LifeSciences Corp.	Integra LifeSciences Corp. (NeuroSciences)	Device Malfunction	Nationwide
22 Apr 2026Device	CLASS II	Cytal Wound Matrix 2-Layer cm. Product ID: WSM1015 recalled	Integra LifeSciences Corp. (NeuroSciences)	Other	Nationwide
22 Apr 2026Device	CLASS II	Cytal Wound Matrix 2-Layer cm. Product ID: WSM0710 recalled	Integra LifeSciences Corp. (NeuroSciences)	Other	Nationwide

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All 13,778

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