- Recalling firm
- Burlington Medical, LLC
- Reason for recall
- Potential for attenuation degradation over time, decreasing the lifespan.
- Affected products (lot / model / serial)
- All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8SL; UDI-DI (Product Code): 00840331271904 (SL8-R8SL). 2. Model Number: R8SL3; UDI-DI (Product Code): 00840331271911 (SL38-R8SL3-LG), 00840331271928 (SL38-R8SL3-MD), 00840331271935 (SL38-R8SL3-SM), 00840186699816 (SL38-R8SL3-XL), 00840331271942 (SL38-R8SL3-XS). 3. Model Number: S8SL; UDI-DI (Product Code): 00840331271959 (SL8-S8SL). 4. Model Number: S8SL3; UDI-DI (Product Code): 00840331271966 (SL38-S8SL3-LG), 00840331271973 (SL38-S8SL3-MD), 00840331271980 (SL38-S8SL3-SM), 00840186699823 (SL38-S8SL3-XL), 00840331271997 (SL38-S8SL3-XS). 5. Model Number: U8SL; UDI-DI (Product Code): 00840331272000 (SL8-U8SL). 6. Model Number: U8SL3; UDI-DI (Product Code): 00840331272017 (SL38-U8SL3-LG), 00840331272024 (SL38-U8SL3-MD), 00840331272031 (SL38-U8SL3-SM), 00840186699830 (SL38-U8SL3-XL), 00840331272048 (SL38-U8SL3-XS).
- Units affected
- 1,129 units
- Distribution pattern
- Worldwide distribution. Nationwide distribution in the US and international distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam.
- Firm location
- Newport News, VA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1759-2026
- Recall initiated
- February 11, 2026
- FDA classification date
- April 2, 2026
- FDA report date
- April 8, 2026
- FDA event ID
- 98415
- Last updated on HTM Vibe
- July 24, 2026