- 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): 8016(16FR); UDI-DI: 00650862130164; Lot Number: ME244878; 2. Model Number(Size): 8024(24FR); UDI-DI: 00650862130249; Lot Number: ME244835; 3. Model Number(Size): 8028(28FR); UDI-DI: 00650862130287; Lot Numbers: ME244682, ME244836, ME244837, ME244681; 4. Model Number(Size): 8032(32FR); UDI-DI: 00650862130324; Lot Number: ME244840; 5. Model Number(Size): 8036(36FR); UDI-DI: 00650862130362; Lot Number: ME244686;
- Units affected
- 3618
- Distribution pattern
- US Nationwide distribution.
- Firm location
- Merrimack, NH, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3111-2026
- 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