Recall Z-1650-2026 ยท KGN Wound Dressing With Animal-Derived Material(S)
Medline Industries, LP
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
| Date | Mar 27, 2026 (initiated Feb 10, 2026) |
| Status | Open, Classified |
| Reason | Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result. |
| Root cause | Under Investigation by firm |
| Action | Firm began notifying customers on 2/10/26 via "Urgent Medical Device Recall" letters. Customers were instructed to immediately locate and quarantine all affected product. Affected product must be destroyed. Customer should respond to the firm to confirm quantity of affected product in inventory. The customer will receive credit from the firm once the response is submitted. Distributors should notify any of their affected downstream accounts. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
| Quantity | 106,621 US; 2,350 OUS |
| Distribution | Domestic distribution nationwide US. International distribution to Mexico and Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060456 | MEDLINE COLLAGEN WOUND DRESSING Medline Industries, Inc., Jun 19, 2006 |