FDA-Device2026-02-25Class IIPACKAGING DEFECT
Integra MediHoney Gel wound dressing recalled for potential sterile packaging failure
OTHERNationwide distribution
Stop using Integra MediHoney Gel dressing
Integra LifeSciences is recalling specific batches of MediHoney Gel wound dressing because the sterile packaging may fail, potentially allowing contamination. This affects models 31805 and 31815 distributed worldwide. No injuries have been reported.
- Check if you have MediHoney Gel Model 31805 or 31815 with the affected lot/serial numbers
- Stop using affected packages immediately
- Contact your healthcare provider or supplier for replacement or instructions
- Do not use the product even if the packaging appears intact
Hazard
Potential packaging failures, which could lead to a breach in the sterile barrier.
Sold states
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.).
Affected count
49,367 units
Manufactured in
1100 Campus Rd, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1363-2026More Integra LifeSciences Corp. (NeuroSciences) recalls
- FDA-Device2026-05-20Integra Codman CerebroFlo EVD Catheter recalled for elevated endotoxin levels
- FDA-Device2026-04-22Integra Cytal Burn Matrix recalled for elevated endotoxin levels
- FDA-Device2026-04-22Integra Cytal Wound Matrix 2-Layer recalled for high endotoxin levels
- FDA-Device2026-04-22Integra Cytal Burn Matrix recalled for elevated endotoxin levels
- FDA-Device2026-04-22Integra Cytal Wound Matrix recalled for elevated endotoxin levels
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