- Recalling firm
- Atrium Medical Corporation
- Reason for recall
- An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
- Affected products (lot / model / serial)
- 1. Model Number(Size): 8124(24FR); UDI-DI: 00650862132243; Lot Number: ME244852; 2. Model Number(Size): 8128(28FR); UDI-DI: 00650862132281; Lot Number: ME244854, ME244855; 3. Model Number(Size): 8132(32FR); UDI-DI: 00650862132328; Lot Numbers: ME244565, ME244858, ME244859; 4. Model Number(Size): 8136(36FR); UDI-DI: 00650862132366; Lot Number: ME244861;
- Units affected
- 2533
- Distribution pattern
- US Nationwide distribution.
- Firm location
- Merrimack, NH, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3112-2026
- Recall initiated
- August 7, 2026
- FDA classification date
- September 4, 2026
- FDA report date
- September 16, 2026
- FDA event ID
- 99680
- Last updated on HTM Vibe
- September 23, 2026