MediHoney Wound Dressing Gel Recall: Induction Seal Packaging Risk
Integra LifeSciences recalls MediHoney Wound & Burn Dressing Gel (model 31815) due to potential unsealed packaging. This could lead to contamination risks for wound care. Affected units include specific lot numbers.
Lower-risk recall
Potential that the induction seal is not completely sealed to the device tube packaging.
Contact the company
What happened, in plain English
Integra LifeSciences is recalling MediHoney Wound & Burn Dressing Gel (model 31815) because the induction seal might not be fully sealed to the packaging. This could allow contaminants to enter the gel, posing a risk for wound infections. Read more at govinfonow.com/recall/53128-medihoney-wound-dressing-gel-recall-induction-seal-packaging-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/53128-medihoney-wound-dressing-gel-recall-induction-seal-packaging-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1168-2025
Cite this page
“MediHoney Wound Dressing Gel Recall: Induction Seal Packaging Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53128-medihoney-wound-dressing-gel-recall-induction-seal-packaging-risk. Based on FDA recall #Z-1168-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1168-2025%22&limit=1).
Why it’s dangerous
The induction seal on the packaging may not be completely sealed, which could allow contaminants to enter the gel. This poses a risk of infection for wounds or burns that are being treated with the product.
Who’s affected
People using MediHoney Wound & Burn Dressing Gel (model 31815) for wound or burn care. Those with open wounds or burns are most at risk from potential contamination.
How to tell if you have this one
Check for the model number 31815 on the MediHoney Gel packaging. Affected units include lot numbers 2328, 2332, and 2333.
- Brand
MediHoney- Category
Medical device
What to do — step by step
Check Packaging Seal
Inspect the induction seal on the packaging for any signs of being improperly sealed.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 45 states.
FDA distribution: “Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV…” 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, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-1168-2025 (January 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1168-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.