FDA DevicesClass II
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,...
Published: April 1, 2026Recall ID: Z-1650-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
Affected Products
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98484 |
| Address 1 | 3 Lakes Dr |
| Code info | MSC8522 - Puracol UDI-DI 10080196285860 (each) 40080196285861 (case) Lot P2090 MSC8622EP - Puracol Plus UDI-DI 10080196296804 (each) 40080196296805 (case) Lot PL2107 |
| Postal code | 60093-2753 |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 106,621 US; 2,350 OUS |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260210 |
| Initial firm notification | Letter |
| Center classification date | 20260326 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionDomestic distribution nationwide US. International distribution to Mexico and Panama.