- 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: R8COPEH; UDI-DI (Product Code): 00840331299052 (COPE-R8COPEH-LG). 2. Model Number: R8TSBBB; UDI-DI (Product Code): 00840331260311 (THYROIDSHIELDO8-R8TSBBB-SM). 3. Model Number: R8TSBBN; UDI-DI: 00840331260328; Product Codes: THYROIDSHIELDO8-R8TSBBN-LG, THYROIDSHIELDO8-R8TSBBN-MD, THYROIDSHIELDO8-R8TSBBN-SM. 4. Model Number: R8TSBBR; UDI-DI (Product Code): 00840331260359 (THYROIDSHIELDO8-R8TSBBR-LG), 00840331260366 (THYROIDSHIELDO8-R8TSBBR-MD), 00840331260373 (THYROIDSHIELDO8-R8TSBBR-SM). 5. Model Number: R8TSBBT; UDI-DI (Product Code): 00840331260397 (THYROIDSHIELDO8-R8TSBBT-MD), 00840331260403 (THYROIDSHIELDO8-R8TSBBT-SM). 6. Model Number: R8TSBHB; UDI-DI (Product Code): 00840331295948 (THYROIDSHIELDO8-R8TSBHB-MD), 00840331295955 (THYROIDSHIELDO8-R8TSBHB-SM). 7. Model Number: R8TSBHN; UDI-DI (Product Code): 00840331260427 (THYROIDSHIELDO8-R8TSBHN-MD ), 00840331260434 (THYROIDSHIELDO8-R8TSBHN-SM ). 8. Model Number: R8TSBHR; UDI-DI (Product Code): 00840331260465 (THYROIDSHIELDO8-R8TSBHR-SM ), 00840331260458 (THYROIDSHIELDO8-R8TSBHR-MD ), 00840331260441 (THYROIDSHIELDO8-R8TSBHR-LG ). 9. Model Number: R8TSBHT; UDI-DI (Product Code): 00840331260489 (THYROIDSHIELDO8-R8TSBHT-MD ), 00840331260496 (THYROIDSHIELDO8-R8TSBHT-SM ). 10. Model Number: R8TSBMB; UDI-DI (Product Code): 00840331295979 (THYROIDSHIELDOM8-R8TSBMB-MD ), 00840331295986 (THYROIDSHIELDOM8-R8TSBMB-SM ). 11. Model Number: R8TSBMN; UDI-DI (Product Code): 00840331260519 (THYROIDSHIELDOM8-R8TSBMN-MD ). 12. Model Number: R8TSBMR; UDI-DI (Product Code): 00840331260533 (THYROIDSHIELDOM8-R8TSBMR-LG ), 00840331260540 (THYROIDSHIELDOM8-R8TSBMR-MD ), 00840331260557 (THYROIDSHIELDOM8-R8TSBMR-SM ). 13. Model Number: R8TSBMT; UDI-DI (Product Code): 00840331260571 (THYROIDSHIELDOM8-R8TSBMT-MD ). 14. Model Number: R8TSCBB; UDI-DI (Product Code): 00840331270525 (THYROIDSHIELD8-R8TSCBB-LG ), 00840331270532 (THYROIDSHIELD8-R8TSCBB-MD ), 00840331270549 (THYROIDSHIELD8-R8TSCBB-SM ). 15. Model Number: R8TSCBN; UDI-DI (Product Code): 00840331260595 (THYROIDSHIELD8-R8TSCBN-LG ), 00840331260601 (THYROIDSHIELD8-R8TSCBN-MD ), 00840331260618 (THYROIDSHIELD8-R8TSCBN-SM ). 16. Model Number: R8TSCBR; UDI-DI (Product Code): 00840331260625 (THYROIDSHIELD8-R8TSCBR-LG ), 00840331260632 (THYROIDSHIELD8-R8TSCBR-MD ), 00840331260649 (THYROIDSHIELD8-R8TSCBR-SM ). 17. Model Number: R8TSCBS; UDI-DI (Product Code): 00840331270594 (THYROIDSHIELD8-R8TSCBS-MD ), 00840331270587 (THYROIDSHIELD8-R8TSCBS-SM ). 18. Model Number: R8TSCBT; UDI-DI (Product Code): 00840331260656 (THYROIDSHIELD8-R8TSCBT-LG ), 00840331260663 (THYROIDSHIELD8-R8TSCBT-MD ), 00840331260670 (THYROIDSHIELD8-R8TSCBT-SM ). 19. Model Number: R8TSCHB; UDI-DI (Product Code): 00840331270495 (THYROIDSHIELD8-R8TSCHB-LG ), 00840331270501 (THYROIDSHIELD8-R8TSCHB-MD ), 00840331270518 (THYROIDSHIELD8-R8TSCHB-SM ). 20. Model Number: R8TSCHN; UDI-DI (Product Code): 00840331260687 (THYROIDSHIELD8-R8TSCHN-LG ), 00840331260694 (THYROIDSHIELD8-R8TSCHN-MD ), 00840331260700 (THYROIDSHIELD8-R8TSCHN-SM ). 21. Model Number: R8TSCHR; UDI-DI (Product Code): 00840331260717 (THYROIDSHIELD8-R8TSCHR-LG ), 00840331260724 (THYROIDSHIELD8-R8TSCHR-MD ), 00840331260731 (THYROIDSHIELD8-R8TSCHR-SM ). 22. Model Number: R8TSCHS; UDI-DI (Product Code): 00840331270563 (THYROIDSHIELD8-R8TSCHS-MD ), 00840331270556 (THYROIDSHIELD8-R8TSCHS-SM ). 23. Model Number: R8TSCHT; UDI-DI (Product Code): 00840331260748 (THYROIDSHIELD8-R8TSCHT-LG ), 00840331260755 (THYROIDSHIELD8-R8TSCHT-MD ), 00840331260762 (THYROIDSHIELD8-R8TSCHT-SM ). 24. Model Number: R8TSCMB; UDI-DI (Product Code): 00840331270464 (THYROIDSHIELDM8-R8TSCMB-LG ), 00840331270471 (THYROIDSHIELDM8-R8TSCMB-MD ), 00840331270488 (THYROIDSHIELDM8-R8TSCMB-SM ). 25. Model Number: R8TSCMN; UDI-DI (Product Code): 00840331260786 (THYROIDSHIELDM8-R8TSCMN-M
- Units affected
- 41,962 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-1753-2026
- 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