Recall Z-1364-2026 ยท FRO Dressing, Wound, Drug
Integra LifeSciences Corp. (NeuroSciences)
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
| Date | Feb 13, 2026 (initiated Jan 16, 2026) |
| Status | Open, Classified |
| Reason | Potential packaging failures, which could lead to a breach in the sterile barrier. |
| Root cause | Under Investigation by firm |
| Action | Integra began notifying consignees on about 01/16/2026 via URGENT: VOLUNTARY MEDICAL DEVICE RECALL letter sent through FedEx and email. Consignees were instructed to immediately cease use of affected units and arrange for their return. Users were instructed to follow-up with their medical provider if the product has been used and they experienced any signs of wound infection. Consignees and distributors were instructed to forward the notification to those who utilize the product for awareness, and to customers, if further distributed. Additionally, consignees and distributors were requested |
| Quantity | 55,276 units |
| Distribution | 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 Republi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053095 | HONEY ALGINATE DRESSING Derma Sciences Canada, Inc., Jul 12, 2007 |