Lower risk Medical device recall · FDA · Published January 16, 2026

MediHoney Gel Dressing Recall: Packaging Failures Risk Sterile Barrier Breach

Integra LifeSciences recalls MediHoney Gel dressings with model numbers 31805 and 31815 due to potential packaging failures that could breach the sterile barrier. Affected units include specific serial and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1363-2026Medical device Integra LifeSciences ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmIntegra LifeSciences Corp. (NeuroSciences)1100 Campus Rd · Princeton, NJ 08540-6650

✎ GovInfoNow plain-language explainer

Integra LifeSciences is recalling MediHoney Gel dressings with model numbers 31805 and 31815 because their packaging might fail, risking a breach in the sterile barrier. This could lead to infection if the dressing is used on wounds. Read more at govinfonow.com/recall/50145-medihoney-gel-dressing-recall-packaging-failures-risk-sterile-barrier-breach.

Source Summary by GovInfoNow · govinfonow.com/recall/50145-medihoney-gel-dressing-recall-packaging-failures-risk-sterile-barrier-breach · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1363-2026

Cite this page

“MediHoney Gel Dressing Recall: Packaging Failures Risk Sterile Barrier Breach.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/50145-medihoney-gel-dressing-recall-packaging-failures-risk-sterile-barrier-breach. Based on FDA recall #Z-1363-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1363-2026%22&limit=1).

Integra LifeSciences Corp. (NeuroSciences) recalled MediHoney Gel with Active Leptospermum Honey due to potential packaging failures that could breach the sterile barrier, according to the FDA on Jan. 16, 2026.

How to tell if you have it

Brand: Integra LifeSciences
Product: MediHoney Gel with Active Leptospermum Honey
Model Numbers: 31805, 31815
Units affected: 49,367

The hazard

The recall cites potential packaging failures that could lead to a breach in the sterile barrier for MediHoney Gel dressings indicated for light to moderately exuding wounds.

Context

GovInfoNow's records show Integra LifeSciences Corp. (NeuroSciences) has had 12 other recalls since April 4, 2025. Recent brand recalls include the OmniTract Surgical Retractor System on June 5, 2026, and the Codman CerebroFlo EVD Catheter on April 10, 2026. Other recent recalls of similar products include Medline Convenience Kits (June 12, 2026) and Medline IVS Blood Culture Kits (June 12, 2026).

How to tell if you have this one

Check the model number on the packaging: 31805 or 31815. Look for specific serial numbers (for model 31805) or lot numbers (for model 31815) listed in the recall notice.

Brand
Integra LifeSciences
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
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.).

Recall number	Product, codes & lots	Quantity
Z-1363-2026	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.; 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.	49,367 units
Z-1364-2026	MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds; (1) Model Number: 31012; UDI-DI: 10381780486909; Lot numbers: A24008, A24057, B21123, B24075, C22159, C23177, C24148, D24190, E21365, E24254, E24255, G23393, H21523, H22452, H23443, I22512, I23464, J21693, L22706. (2) Model Number: 31022; UDI-DI: 10381780486916; Lot numbers: A23045, A23065, A25028, A25056, B23079, B25068, B25077, C21151, C21152, C21155, C21195, C22182, C22196, C23183, C23193, C25152, D23196, D23208, E21300, E22305, E22319, F21407, F21428, F21430, F22333, F24317, G23405, H21544, H22438, H23415, H23442, H23446, H24415, I21610, I21617, J22530 , J23551, J23560, J24622, K21723, K21739, K24625, K24646, L21838. (3) Model Number: 31045; UDI-DI: 10381780486923; Lot numbers: A21056, A22036, A22047, A24036, B21062, B21084, B21100, B21107, B21119, B25110, D21229, D21247, D22251, D22270, D22275, D23236, D23248, D24192, D24220, E21314, E21337, E21361, E22277, E23253, E23271, E24296, F21376, F22361, F22362, F22382, F23369, F23370, G21490, G21504, G22385, G23384, H21506, H21512, H21530, H23450, H23451, I22479, I22481, I22495, I23466, I23498, I24511, I24523, J21680, J21691, K21777, K21801, K21806, K22597, K22609, K22632, K22663, K24650, K24679, L21812, L21823, L22674, L22711, L23649.	55,276 units
Z-1365-2026	Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.; Model Number: CVS405406; UDI-DI: 00050428452547; Lot Numbers: 2428, 2446, 2509, 2514.	2,906 units

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the model number and serial/lot numbers to confirm if your MediHoney Gel is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 13 states.

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

Named in the notice: California, Florida, Indiana, Michigan, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia.

Recall timeline

FDA published this recall 40 days after the firm started it.

Jan 16, 2026Firm started the recall
Feb 13, 2026FDA classified it Class II
Feb 25, 2026Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/50145-medihoney-gel-dressing-recall-packaging-failures-risk-sterile-barrier-breach">MediHoney Gel Dressing Recall: Packaging Failures Risk Sterile Barrier Breach (GovInfoNow)</a>

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-1363-2026 (January 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1363-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.