Recall Z-2677-2026 ยท FRO Dressing, Wound, Drug
ConvaTec, Inc
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
| Date | Jul 7, 2026 (initiated Jun 8, 2026) |
| Status | Open, Classified |
| Reason | Surgical dressing manufactured out of specification (greater thickness). |
| Root cause | Nonconforming Material/Component |
| Action | On June 8, 2026, Convatec issued a Urgent Medical Device Recall Notification via Email. Convatec asked consignees to take the following actions: Cease use and distribution of the impacted lots; 2. Identify and quarantine any affected product in the inventory. 3. Notify all relevant personel. End users / Patients 1.Discontinue use and dispose of the affected product. 2.Review your personal supplies and determine if you are affected by this communication. 3.Complete response form and return to Convatec within 30-days. Distributors, Wholesalers, Clinical Facilities, & Hospitals. Transmissi |
| Quantity | 4230 units |
| Distribution | US Nationwide distribution in the states of MD, OH, IL, NC, AZ, NY, MN, TX, KS, TN, IN, DE, MI, FL, PA, CA, VA, MS, NM, GA, CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152926 | AQUACEL Ag Surgical SP Dressing Convatec Limited, Jan 21, 2016 |