- 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.
- Affected products (lot / model / serial)
- MSC8522 - Puracol UDI-DI 10080196285860 (each) 40080196285861 (case) Lot P2090 MSC8622EP - Puracol Plus UDI-DI 10080196296804 (each) 40080196296805 (case) Lot PL2107
- Units affected
- 106,621 US; 2,350 OUS
- Distribution pattern
- Domestic distribution nationwide US. International distribution to Mexico and Panama.
- Firm location
- Northfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1650-2026
- Recall initiated
- February 10, 2026
- FDA classification date
- March 26, 2026
- FDA report date
- April 1, 2026
- FDA event ID
- 98484
- Last updated on HTM Vibe
- July 24, 2026