Z-1650-2026 Class II Ongoing
FDA device recall Z-1650-2026 was initiated by Medline Industries, LP on February 10, 2026 and is designated Class II. 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 feve… The recall status is ongoing. Affected quantity: 106,621 US; 2,350 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2026
- Initiation Date
- February 10, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 106,621 US; 2,350 OUS
Product Description
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.
Distribution Pattern
Domestic distribution nationwide US. International distribution to Mexico and Panama.
Code Information
MSC8522 - Puracol UDI-DI 10080196285860 (each) 40080196285861 (case) Lot P2090 MSC8622EP - Puracol Plus UDI-DI 10080196296804 (each) 40080196296805 (case) Lot PL2107