- 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: R8KILTBLOCKER10X12; UDI-DI (Product Code): 00840331272727 (KILTBLOCKER8-R8KILTBLOCKER10X12). 2. Model Number: R8KILTBLOCKER12X12; UDI-DI (Product Code): 00197513011293 (KILTBLOCKER8-R8KILTBLOCKER12X12). 3. Model Number: R8KILTBLOCKER18X20; UDI-DI (Product Code): 00840331272741 (KILTBLOCKER8-R8KILTBLOCKER18X20). 4. Model Number: R8KILTBLOCKER20X24; UDI-DI (Product Code): 00840331272758 (KILTBLOCKER8-R8KILTBLOCKER20X24). 5. Model Number: R8KILTBLOCKER24X24; UDI-DI (Product Code): 00840331272765 (KILTBLOCKER8-R8KILTBLOCKER24X24). 6. Model Number: S8KILTBLOCKER10X10; UDI-DI (Product Code): 00840331272772 (KILTBLOCKER8-S8KILTBLOCKER10X10). 7. Model Number: S8KILTBLOCKER10X12; UDI-DI (Product Code): 00840331272789 (KILTBLOCKER8-S8KILTBLOCKER10X12). 8. Model Number: S8KILTBLOCKER12X12; UDI-DI (Product Code): 00197513011309 (KILTBLOCKER8-S8KILTBLOCKER12X12). 9. Model Number: S8KILTBLOCKER18X20; UDI-DI (Product Code): 00840331272802 (KILTBLOCKER8-S8KILTBLOCKER18X20). 10. Model Number: S8KILTBLOCKER20X24; UDI-DI (Product Code): 00840331272819 (KILTBLOCKER8-S8KILTBLOCKER20X24). 11. Model Number: S8KILTBLOCKER24X24; UDI-DI (Product Code): 00840331272826 (KILTBLOCKER8-S8KILTBLOCKER24X24). 12. Model Number: U8KILTBLOCKER12X12; UDI-DI (Product Code): 00197513011316 (KILTBLOCKER8-U8KILTBLOCKER12X12). 13. Model Number: U8KILTBLOCKER18X20; UDI-DI (Product Code): 00840331272864 (KILTBLOCKER8-U8KILTBLOCKER18X20). 14. Model Number: U8KILTBLOCKER20X24; UDI-DI (Product Code): 00840331272871 (KILTBLOCKER8-U8KILTBLOCKER20X24). 15. Model Number: U8KILTBLOCKER24X24; UDI-DI (Product Code): 00840331272888 (KILTBLOCKER8-U8KILTBLOCKER24X24).
- Units affected
- 94 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-1765-2026
- 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