Safety Alert: Class II: Packaging failures were identified which could lead to a breach in the sterile barrier.
healthClass IIRecalled on Sep 10, 2025
Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620
🔢 5374 units
Sold At: Integra LifeSciences Corp. (NeuroSciences)(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, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.)
Recall #: FDA-DEVICE-Z-2509-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Model/Catalog Number: (1) 31620, (2) 31640; UDIs: (1) 10381780471370, (2) 10381780471400; Lot#s: (1) 30623, 40724, 25022, 23823, 54922, 24123, 54322, 54023, 23024, 43823, 13424, (2) 24423, 53424, 11323, 51324, 10823, 20224, 30823, 24623, 33524, 34523;
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Summary
Packaging failures were identified which could lead to a breach in the sterile barrier.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Integra LifeSciences Corp. (NeuroSciences) for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.