Dressing Recall: MediHoney Hydrogel 31722/31744
Announced 2026-07-15 · FDA
Integra LifeSciences Corp. recalls MediHoney Hydrogel Adhesive Sheet Dressing due to packaging failures that could breach the sterile barrier. The recall involves 1,147 units distributed worldwide, including US nationwide, with model numbers 31722 and 31744; UDIs 10381780471387 and 10381780471394; and lot numbers 44422, 14223, 50423, 12523. No corrective action is listed.
| Brand | Integra LifeSciences Corp. (NeuroSciences) |
|---|---|
| Product | Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel colloidal gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does not require a secondary dressing. |
| Reason | Packaging failures were identified which could lead to a breach in the sterile barrier. |
| Severity | moderate |
| Units affected | 633 |
| 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, 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. |
| Agency | FDA |
| Recall / campaign no. | Model/Catalog Numbers: (1) 31722, (2) 31744; UDIs - (1) 10381780471387, (2) 10381780471394; Lot #s: (1) 44422, 14223, (2) 50423, 12523; |
WHAT YOU SHOULD DO
- Do not use any MediHoney Hydrogel Adhesive Sheet Dressing with catalog numbers 31722 or 31744 or with the listed UDIs or lot numbers; set affected products aside.
- Contact the seller or Integra LifeSciences to arrange a replacement or return per the recall instructions.
- If you have used the product and have concerns, consult your healthcare provider.
- For more information, check the FDA recall notice.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.