FDA-Device2026-02-25Class IIPACKAGING DEFECT
Integra MediHoney Gel wound dressing recalled for potential sterile packaging failure
What this means
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
The agency's original wording
Hazard
Potential packaging failures, which could lead to a breach in the sterile barrier.
Intended for
All ages
Illnesses reported
None reported
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-1363-2026Want us to check the next one for you?
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