Recall Z-2506-2025 ยท FRO Dressing, Wound, Drug
Integra LifeSciences Corp. (NeuroSciences)
Brand Name: MediHoney Product Name: MediHoney Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing
| 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 | 141620 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
| K080315 | DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY Derma Sciences, Inc., Apr 23, 2008 |