Recall Z-2509-2025 ยท FRO Dressing, Wound, Drug
Integra LifeSciences Corp. (NeuroSciences)
Brand Name: MediHoney Product Name: MediHoney Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel gelling agent. The gelling agent is contained within the dressing mass. The dressing contains 100%, Leptospermum Honey. As wound
| Date | Sep 3, 2025 (initiated Aug 5, 2025) |
| Status | Open, Classified |
| Reason | Packaging failures were identified which could lead to a breach in the sterile barrier. |
| Root cause | Under Investigation by firm |
| Action | On August 5, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions for Customers: If you have units of the impacted product remove them immediately from service and quarantine them. Forward this notice to those who utilize the product so they are aware of this recall and can identify any affected product that may remain in clinical areas. Complete the entirety of the Acknowledgement Form and send via email to FCA4@integralife.com or FAX to 1-609-750-4220. Keep a copy of the form for your records. Actions for Distributors: If you have products listed in Table 1, remove the |
| Quantity | 5374 units |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110546 | MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY Derma Sciences, Inc., Jul 27, 2011 |