Burlington Medical, Thyroid Shield.

Summary

The FDA issued a Class II for Burlington Medical, Thyroid Shield. by Burlington Medical, LLC. Reason: Potential for attenuation degradation over time, decreasing the lifespan..

Details

Product Description

Burlington Medical, Thyroid Shield.

Lot/Code Info: 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-MD ), 00840331260793 (THYROIDSHIELDM8-R8TSCMN-SM ). 26. Model Number: R8TSCMR; UDI-DI (Product Code): 00840331260809 (THYROIDSHIELDM8-R8TSCMR-LG ), 00840331260816 (THYROIDSHIELDM8-R8TSCMR-MD ), 00840331260823 (THYROIDSHIELDM8-R8TSCMR-SM ). 27. Model Number: R8TSCMS; UDI-DI (Product Code): 00840331260830 (THYROIDSHIELDM8-R8TSCMS-MD ), 00840331260847 (THYROIDSHIELDM8-R8TSCMS-SM ). 28. Model Number: R8TSCMT; UDI-DI (Product Code): 00840331260854 (THYROIDSHIELDM8-R8TSCMT-LG ), 00840331260861 (THYROIDSHIELDM8-R8TSCMT-MD ), 00840331260878 (THYROIDSHIELDM8-R8TSCMT-SM ). 29. Model Number: R8TSOBB; UDI-DI (Product Code): 00840331271430 (THYROIDSHIELDO8-R8TSOBB-MD ). 30. Model Number: R8TSOBN; UDI-DI (Product Code): 00840331260892 (THYROIDSHIELDO8-R8TSOBN-MD ). 31. Model Number: R8TSOBR; UDI-DI (Product Code): 00840331260922 (THYROIDSHIELDO8-R8TSOBR-MD ), 00840331260939 (THYROIDSHIELDO8-R8TSOBR-SM ). 32. Model Number: R8TSOHB; UDI-DI (Product Code): 00840331260939 (THYROIDSHIELDO8-R8TSOHB-MD, THYROIDSHIELDO8-R8TSOHB-SM ). 33. Model Number: R8TSOHR; UDI-DI (Product Code): 00840331261011 (THYROIDSHIELDO8-R8TSOHR-MD ), 00840331261028 (THYROIDSHIELDO8-R8TSOHR-SM ). 34. Model Number: R8TSOHT; UDI-DI (Product Code): 00840331261035 (THYROIDSHIELDO8-R8TSOHT-LG ). 35. Model Number: R8TSOMN; UDI-DI (Product Code): 00840331261080 (THYROIDSHIELDOM8-R8TSOMN-SM ). 36. Model Number: R8TSOMR; UDI-DI (Product Code): 00840331261097 (THYROIDSHIELDOM8-R8TSOMR-LG ), 00840331261103 (THYROIDSHIELDOM8-R8TSOMR-MD ), 00840331261110 (THYROIDSHIELDOM8-R8TSOMR-SM ). 37. Model Number: R8TSOMT; UDI-DI (Product Code): 00840331261141 (THYROIDSHIELDOM8-R8TSOMT-SM ). 38. Model Number: R8TSSBB; UDI-DI (Product Code): 00840331270976 (THYROIDSHIELD8-R8TSSBB-LG ), 00840331270983 (THYROIDSHIELD8-R8TSSBB-MD ), 00840331270990 (THYROIDSHIELD8-R8TSSBB-SM ). 39. Model Number: R8TSSBN ; UDI-DI (Product Code): 00840331261165 (THYROIDSHIELD8-R8TSSBN-MD ), 00840331261172 (THYROIDSHIELD8-R8TSSBN-SM ), None (THYROIDSHIELDP8-R8TSSBN-PD ). 40. Model Number: R8TSSBR; UDI-DI (Product Code): 00840331261189 (THYROIDSHIELD8-R8TSSBR-LG ), 00840331261196 (THYROIDSHIELD8-R8TSSBR-MD ), 00840331261202 (THYROIDSHIELD8-R8TSSBR-SM ). 41. Model Number: R8TSSBS; UDI-DI (Product Code): 00840331271041 (THYROIDSHIELD8-R8TSSBS-MD ), 00840331271034 (THYROIDSHIELD8-R8TSSBS-SM ). 42. Model Number: R8TSSBT; UDI-DI (Product Code): 00840331261226 (THYROIDSHIELD8-R8TSSBT-MD ). 43. Model Number: R8TSSHB; UDI-DI (Product Code): 00840331270952 (THYROIDSHIELD8-R8TSSHB-MD ), 00840331270969 (THYROIDSHIELD8-R8TSSHB-SM ). 44. Model Number: R8TSSHN; UDI-DI (Product Code): 00840331261257 (THYROIDSHIELD8-R8TSSHN-MD ), 00840331261264 (THYROIDSHIELD8-R8TSSHN-SM ). 45. Model Number: R8TSSHR; UDI-DI (Product Code): 00840331261271 (THYROIDSHIELD8-R8TSSHR-LG ), 00840331261288 (THYROIDSHIELD8-R8TSSHR-MD ), 00840331261295 (THYROIDSHIELD8-R8TSSHR-SM ). 46. Model Number: R8TSSHS; UDI-DI (Product Code): 00840331271010 (THYROIDSHIELD8-R8TSSHS-MD ), 00840331271003 (THYROIDSHIELD8-R8TSSHS-SM ). 47. Model Number: R8TSSHT; UDI-DI (Product Code): 00840331261318 (THYROIDSHIELD8-R8TSSHT-MD ), 00840331261325 (THYROIDSHIELD8-R8TSSHT-SM ). 48. Model Number: R8TSSMB; UDI-DI (Product Code): 00840331270921 (THYROIDSHIELDM8-R8TSSMB-MD ), 00840331270938 (THYROIDSHIELDM8-R8TSSMB-SM ). 49. Model Number: R8TSSMN; UDI-DI (Product Code): 00840331261349 (THYROIDSHIELDM8-R8TSSMN-MD ), 00840331261356 (THYROIDSHIELDM8-R8TSSMN-SM ). 50. Model Number: R8TSSMR; UDI-DI (Product Code): 00840331261363 (THYROIDSHIELDM8-R8TSSMR-LG ), 00840331261370 (THYROIDSHIELDM8-R8TSSMR-MD ), 00840331261387 (THYROIDSHIELDM8-R8TSSMR-SM ). 51. Model Number: R8TSSMS; UDI-DI (Product Code): (THYROIDSHIELDM8-R8TSSMS-MD ), (THYROIDSHIELDM8-R8TSSMS-SM ). 52. Model Number: R8TSSMT; UDI-DI (Product Code): 00840331261400 (THYROIDSHIELDM8-R8TSSMT-MD ), 00840331261417 (THYROIDSHIELDM8-R8TSSMT-SM ). 53. Model Number: R8TSVBN; UDI-DI (Product Code): 00840331261431 (THYROIDSHIELD8-R8TSVBN-MD ). 54. Model Number: R8TSVBR; UDI-DI (Product Code): 00840331261462 (THYROIDSHIELD8-R8TSVBR-MD ), 00840331261479 (THYROIDSHIELD8-R8TSVBR-SM ). 55. Model Number: R8TSVHR; UDI-DI (Product Code): 00840331261547 (THYROIDSHIELD8-R8TSVHR-LG ), 00840331261554 (THYROIDSHIELD8-R8TSVHR-MD ), 00840331261561 (THYROIDSHIELD8-R8TSVHR-SM ). 56. Model Number: R8TSVHT; UDI-DI (Product Code): 00840331261561 (THYROIDSHIELD8-R8TSVHT-MD ), 00840331261622 (THYROIDSHIELD8-R8TSVHT-SM ). 57. Model Number: R8TSVMN; UDI-DI (Product Code): 00840331261646 (THYROIDSHIELDM8-R8TSVMN-MD ), 00840331261653 (THYROIDSHIELDM8-R8TSVMN-SM ). 58. Model Number: R8TSVMR; UDI-DI (Product Code): 00840331261660 (THYROIDSHIELDM8-R8TSVMR-LG ), 00840331261677 (THYROIDSHIELDM8-R8TSVMR-MD ), 00840331261684 (THYROIDSHIELDM8-R8TSVMR-SM ). 59. Model Number: R8TSVMT; UDI-DI (Product Code): 00840331261738 (THYROIDSHIELDM8-R8TSVMT-MD ), 00840331261745 (THYROIDSHIELDM8-R8TSVMT-SM ). 60. Model Number: S8TSBHR; UDI-DI (Product Code): 00840331296006 (THYROIDSHIELDO8-S8TSBHR-MD ). 61. Model Number: S8TSBHT; UDI-DI (Product Code): 00840331264197 (THYROIDSHIELDO8-S8TSBHT-LG ). 62. Model Number: S8TSBMB; UDI-DI (Product Code): 00840331264265 (THYROIDSHIELDOM8-S8TSBMB-MD ). 63. Model Number: S8TSBMR; UDI-DI (Product Code): 00840331264265 (THYROIDSHIELDOM8-S8TSBMR-MD ), 00840331264272 (THYROIDSHIELDOM8-S8TSBMR-SM ). 64. Model Number: S8TSCBB; UDI-DI (Product Code): 00840331270693 (THYROIDSHIELD8-S8TSCBB-SM ). 65. Model Number: S8TSCBN; UDI-DI (Product Code): 00840331264326 (THYROIDSHIELD8-S8TSCBN-MD ). 66. Model Number: S8TSCBR; UDI-DI (Product Code): 00840331264340 (THYROIDSHIELD8-S8TSCBR-LG ), 00840331264357 (THYROIDSHIELD8-S8TSCBR-MD ), 00840331264364 (THYROIDSHIELD8-S8TSCBR-SM ). 67. Model Number: S8TSCBT; UDI-DI (Product Code): 00840331264388 (THYROIDSHIELD8-S8TSCBT-MD ), 00840331264395 (THYROIDSHIELD8-S8TSCBT-SM ). 68. Model Number: S8TSCHN; UDI-DI (Product Code): 00840331264401 (THYROIDSHIELD8-S8TSCHN-LG ), 00840331264418 (THYROIDSHIELD8-S8TSCHN-MD ). 69. Model Number: S8TSCHR; UDI-DI (Product Code): 00840331264432 (THYROIDSHIELD8-S8TSCHR-LG ), 00840331264449 (THYROIDSHIELD8-S8TSCHR-MD ), 00840331264456 (THYROIDSHIELD8-S8TSCHR-SM ). 70. Model Number: S8TSCHT; UDI-DI (Product Code): 00840331264470 (THYROIDSHIELD8-S8TSCHT-MD ). 71. Model Number: S8TSCMB; UDI-DI (Product Code): 00840331270617 (THYROIDSHIELDM8-S8TSCMB-LG ). 72. Model Number: S8TSCMN; UDI-DI (Product Code): 00840331264517 (THYROIDSHIELDM8-S8TSCMN-SM ). 73. Model Number: S8TSCMR; UDI-DI (Product Code): 00840331264524 (THYROIDSHIELDM8-S8TSCMR-LG ), 00840331264531 (THYROIDSHIELDM8-S8TSCMR-MD ), 00840331264548 (THYROIDSHIELDM8-S8TSCMR-SM ). 74. Model Number: S8TSCMS; UDI-DI (Product Code): 00840331264555 (THYROIDSHIELDM8-S8TSCMS-MD ), 00840331264562 (THYROIDSHIELDM8-S8TSCMS-SM ). 75. Model Number: S8TSCMT; UDI-DI (Product Code): 00840331264579 (THYROIDSHIELDM8-S8TSCMT-LG ), 00840331264586 (THYROIDSHIELDM8-S8TSCMT-MD ), 00840331264593 (THYROIDSHIELDM8-S8TSCMT-SM ). 76. Model Number: S8TSOBR; UDI-DI (Product Code): 00840331264807 (THYROIDSHIELDO8-S8TSOBR-LG ), 00840331264784 (THYROIDSHIELDO8-S8TSOBR-SM ). 77. Model Number: S8TSSBN; UDI-DI (Product Code): 00840331264883 (THYROIDSHIELD8-S8TSSBN-MD ). 78. Model Number: S8TSSBR; UDI-DI (Product Code): 00840331264906 (THYROIDSHIELD8-S8TSSBR-LG ), 00840331264913 (THYROIDSHIELD8-S8TSSBR-MD ), 00840331264920 (THYROIDSHIELD8-S8TSSBR-SM ). 79. Model Number: S8TSSBT; UDI-DI (Product Code): 00840331264944 (THYROIDSHIELD8-S8TSSBT-MD ). 80. Model Number: S8TSSHR; UDI-DI (Product Code): 00840331264999 (THYROIDSHIELD8-S8TSSHR-LG ), 00840331265002 (THYROIDSHIELD8-S8TSSHR-MD ), 00840331265019 (THYROIDSHIELD8-S8TSSHR-SM ). 81. Model Number: S8TSSHS; UDI-DI (Product Code): 00840331271164 (THYROIDSHIELD8-S8TSSHS-MD ). 82. Model Number: S8TSSHT; UDI-DI (Product Code): 00840331265033 (THYROIDSHIELD8-S8TSSHT-MD ). 83. Model Number: S8TSSMN; UDI-DI (Product Code): 00840331265064 (THYROIDSHIELDM8-S8TSSMN-MD ). 84. Model Number: S8TSSMR; UDI-DI (Product Code): 00840331265088 (THYROIDSHIELDM8-S8TSSMR-LG ), 00840331265095 (THYROIDSHIELDM8-S8TSSMR-MD ), 00840331265101 (THYROIDSHIELDM8-S8TSSMR-SM ). 85. Model Number: S8TSSMS; UDI-DI (Product Code): (THYROIDSHIELDM8-S8TSSMS-MD ). 86. Model Number: S8TSSMT; UDI-DI (Product Code): 00840331265118 (THYROIDSHIELDM8-S8TSSMT-LG ), 00840331265132 (THYROIDSHIELDM8-S8TSSMT-SM ). 87. Model Number: S8TSVBB; UDI-DI (Product Code): 00840331271799 (THYROIDSHIELD8-S8TSVBB-MD ). 88. Model Number: S8TSVBR; UDI-DI (Product Code): 00840331265187 (THYROIDSHIELD8-S8TSVBR-MD ). 89. Model Number: S8TSVHR; UDI-DI (Product Code): 00840331265279 (THYROIDSHIELD8-S8TSVHR-MD ), 00840331265286 (THYROIDSHIELD8-S8TSVHR-SM ). 90. Model Number: S8TSVMR; UDI-DI (Product Code): 00840331265392 (THYROIDSHIELDM8-S8TSVMR-MD ), 00840331265408 (THYROIDSHIELDM8-S8TSVMR-SM ). 91. Model Number: U8TSBBR; UDI-DI (Product Code): 00840331267853 (THYROIDSHIELDO8-U8TSBBR-SM ). 92. Model Number: U8TSBMN; UDI-DI (Product Code): 00840331267990 (THYROIDSHIELDOM8-U8TSBMN-MD ). 93. Model Number: U8TSBMR; UDI-DI (Product Code): 00840331268010 (THYROIDSHIELDOM8-U8TSBMR-LG ), 00840331268027 (THYROIDSHIELDOM8-U8TSBMR-MD ). 94. Model Number: U8TSCBN; UDI-DI (Product Code): 00840331268089 (THYROIDSHIELD8-U8TSCBN-MD ). 95. Model Number: U8TSCBR; UDI-DI (Product Code): 00840331268102 (THYROIDSHIELD8-U8TSCBR-LG ), 00840331268119 (THYROIDSHIELD8-U8TSCBR-MD ), 00840331268126 (THYROIDSHIELD8-U8TSCBR-SM ). 96. Model Number: U8TSCBT; UDI-DI (Product Code): 00840331268140 (THYROIDSHIELD8-U8TSCBT-MD ). 97. Model Number: U8TSCHR; UDI-DI (Product Code): 00840331268201 (THYROIDSHIELD8-U8TSCHR-MD ), 00840331268218 (THYROIDSHIELD8-U8TSCHR-SM ). 98. Model Number: U8TSCMR; UDI-DI (Product Code): 00840331268294 (THYROIDSHIELDM8-U8TSCMR-MD ), 00840331268300 (THYROIDSHIELDM8-U8TSCMR-SM ). 99. Model Number: U8TSCMT; UDI-DI (Product Code): 00840331268324 (THYROIDSHIELDM8-U8TSCMT-MD ), 00840331268331 (THYROIDSHIELDM8-U8TSCMT-SM ). 100. Model Number: U8TSOMR; UDI-DI (Product Code): 00840331268560 (THYROIDSHIELDOM8-U8TSOMR-MD ). 101. Model Number: U8TSSBN; UDI-DI (Product Code): 00840331268621 (THYROIDSHIELD8-U8TSSBN-MD ). 102. Model Number: U8TSSBR; UDI-DI (Product Code): 00840331268652 (THYROIDSHIELD8-U8TSSBR-MD ). 103. Model Number: U8TSSHN; UDI-DI (Product Code): 00840331268713 (THYROIDSHIELD8-U8TSSHN-MD ). 104. Model Number: U8TSSHR; UDI-DI (Product Code): 00840331268737 (THYROIDSHIELD8-U8TSSHR-LG ), 00840331268744 (THYROIDSHIELD8-U8TSSHR-MD ). 105. Model Number: U8TSSMR; UDI-DI (Product Code): 00840331268829 (THYROIDSHIELDM8-U8TSSMR-LG ), 00840331268836 (THYROIDSHIELDM8-U8TSSMR-MD ), 00840331268843 (THYROIDSHIELDM8-U8TSSMR-SM ). 106. Model Number: U8TSSMS; UDI-DI (Product Code): None (THYROIDSHIELDM8-U8TSSMS-SM ). 107. Model Number: U8TSSMT; UDI-DI (Product Code): 00840331268867 (THYROIDSHIELDM8-U8TSSMT-MD ), 00840331268874 (THYROIDSHIELDM8-U8TSSMT-SM ). 108. Model Number: U8TSVMR; UDI-DI (Product Code): 00840331269130 (THYROIDSHIELDM8-U8TSVMR-MD ), 00840331269147 (THYROIDSHIELDM8-U8TSVMR-SM ).

Quantity Affected: 41,962 units

Reason for Recall

Potential for attenuation degradation over time, decreasing the lifespan.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-02-11

Company