Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COL
FDA device recall Z-1650-2026 · posted 2026-03-27 · Open, Classified
Recall details
- Recalling firm
- Medline Industries, LP
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- KGN
- Quantity affected
- 106,621 US; 2,350 OUS
- Distribution
- Domestic distribution nationwide US. International distribution to Mexico and Panama.
- Date initiated
- 2026-02-10
- Date posted
- 2026-03-27
- Location
- Northfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDLINE COLLAGEN WOUND DRESSING (K060456) | Medline Industries, Inc. | 2006-06-19 |