FDA-Device2026-02-25Class IIPACKAGING DEFECT
Integra LifeSciences MEDIHONEY Calcium Alginate dressing recalled for sterile packaging failure
What this means
Integra LifeSciences has recalled certain lots of MEDIHONEY Calcium Alginate dressing due to potential packaging failures that could compromise the sterile barrier. If the sterile seal is broken, the wound dressing may become contaminated before use. This affects three model numbers distributed worldwide, including to healthcare facilities in the US and internationally.
- Check the model number and lot number on your MEDIHONEY dressing package against the recall list
- Do not use the product if it matches an affected lot number
- Contact your supplier or Integra LifeSciences for instructions on replacement or disposal
- If you have already used an affected dressing, monitor the wound for signs of infection
The agency's original wording
Hazard
Potential packaging failures, which could lead to a breach in the sterile barrier.
Intended for
Adults
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
55,276 units
Manufactured in
1100 Campus Rd, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1364-2026Want us to check the next one for you?
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