Lower riskMedical device recall · FDA · Published September 13, 2024
Integra MEDIHONEY Dressing Recall: Pinholes in Applicator Pouch Risk Sterility
Integra LifeSciences recalls MEDIHONEY Dressing with Active Leptospermum Honey wound and burn dressings (Model 31515/31535) due to potential pinholes in the applicator pouch film that could compromise sterility.
“Integra MEDIHONEY Dressing Recall: Pinholes in Applicator Pouch Risk Sterility.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54027-integra-medihoney-dressing-recall-pinholes-in-applicator-pouch-risk-sterility. Based on FDA recall #Z-0054-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0054-2025%22&limit=1).
Integra LifeSciences Corp. voluntarily recalled MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR due to potential pinholes in the applicator pouch film that create a sterility concern, the FDA said on Sept. 13, 2024.
How to tell if you have it
Brand: Integra LifeSciences
Product: MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR
Model Number 31515 (1.5oz tube); UDI-DI: 10381780486824
Model Number 31535 (3.5oz tube); UDI-DI: 10381780486831
Lots distributed from 12/17/2020 to 07/22/2024 with expiration dates 08/01/2024 to 06/01/2028
The hazard
There is a potential for pinholes in the applicator pouch film which creates a sterility concern, according to the FDA.
Context
GovInfoNow's records show Integra LifeSciences Corp. has 35 other recalls on record since 2025-02-06. Other recent recalls of similar products include MEDIHONEY Calcium Alginate Dressing Recall (2026-01-16), MediHoney Gel Dressing Recall (2026-01-16) and Integra CVS Wound Dressing Recall (2026-01-16).
How to tell if you have this one
Check for the model numbers 31515 (1.5oz) or 31535 (3.5oz) on the packaging. The product was sold from December 17, 2020, to July 22, 2024, with expiration dates from August 1, 2024, to June 1, 2028.
Brand
Integra LifeSciences
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for model numbers 31515 or 31535 on the packaging to confirm if the product is recalled.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 43 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of MN, IL, UT, FL, NC, CA, MO, IN, MS, OH, PA, TX, HI, MA, WA, GA, AZ, VA, NY, CO, MI, OK, NV, NJ, SC, OR, VT, DC, WI, TN, WV, KS, AL, NE, MD, ID, LA, AR, KY, IA, AK, NM, ME, RI and the…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 33 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0054-2025 (September 13, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0054-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.