Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING — Class II medical device recall Z-1650-2026
Ongoing recall by Medline Industries, LP, reported 2026-04-01, distributed nationwide. Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used,
| Recall number | Z-1650-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-02-10 |
| Classified | 2026-03-26 |
| Reported by FDA | 2026-04-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX, PA |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10080196285860, 10080196296804, 40080196285861, 40080196296805 |
| Lot numbers | MSC8622EP, P2090, PL2107 |
Product
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1650-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.