{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 13 } }, "results": [ { "cfres_id": "218653", "product_res_number": "Z-1753-2026", "event_date_initiated": "2026-02-11", "event_date_posted": "2026-04-02", "recall_status": "Open, Classified", "res_event_number": "98415", "product_code": "IWO", "product_description": "Burlington Medical, Thyroid Shield.", "code_info": "All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. \n\n1. Model Number: R8COPEH; UDI-DI (Product Code): 00840331299052 (COPE-R8COPEH-LG). \n\n2. Model Number: R8TSBBB; UDI-DI (Product Code): 00840331260311 (THYROIDSHIELDO8-R8TSBBB-SM). \n\n3. Model Number: R8TSBBN; UDI-DI: 00840331260328; Product Codes: THYROIDSHIELDO8-R8TSBBN-LG, THYROIDSHIELDO8-R8TSBBN-MD, THYROIDSHIELDO8-R8TSBBN-SM. \n\n4. Model Number: R8TSBBR; UDI-DI (Product Code): 00840331260359 (THYROIDSHIELDO8-R8TSBBR-LG), 00840331260366 (THYROIDSHIELDO8-R8TSBBR-MD), 00840331260373 (THYROIDSHIELDO8-R8TSBBR-SM). \n\n5. Model Number: R8TSBBT; UDI-DI (Product Code): 00840331260397 (THYROIDSHIELDO8-R8TSBBT-MD), 00840331260403 (THYROIDSHIELDO8-R8TSBBT-SM). \n\n6. Model Number: R8TSBHB; UDI-DI (Product Code): 00840331295948 (THYROIDSHIELDO8-R8TSBHB-MD), 00840331295955 (THYROIDSHIELDO8-R8TSBHB-SM). \n\n7. Model Number: R8TSBHN; UDI-DI (Product Code): 00840331260427 (THYROIDSHIELDO8-R8TSBHN-MD ), 00840331260434 (THYROIDSHIELDO8-R8TSBHN-SM ). \n\n8. Model Number: R8TSBHR; UDI-DI (Product Code): 00840331260465 (THYROIDSHIELDO8-R8TSBHR-SM ), 00840331260458 (THYROIDSHIELDO8-R8TSBHR-MD ), 00840331260441 (THYROIDSHIELDO8-R8TSBHR-LG ). \n\n9. Model Number: R8TSBHT; UDI-DI (Product Code): 00840331260489 (THYROIDSHIELDO8-R8TSBHT-MD ), 00840331260496 (THYROIDSHIELDO8-R8TSBHT-SM ). \n\n10. Model Number: R8TSBMB; UDI-DI (Product Code): 00840331295979 (THYROIDSHIELDOM8-R8TSBMB-MD ), 00840331295986 (THYROIDSHIELDOM8-R8TSBMB-SM ). \n\n11. Model Number: R8TSBMN; UDI-DI (Product Code): 00840331260519 (THYROIDSHIELDOM8-R8TSBMN-MD ). \n\n12. Model Number: R8TSBMR; UDI-DI (Product Code): 00840331260533 (THYROIDSHIELDOM8-R8TSBMR-LG ), 00840331260540 (THYROIDSHIELDOM8-R8TSBMR-MD ), 00840331260557 (THYROIDSHIELDOM8-R8TSBMR-SM ). \n\n13. Model Number: R8TSBMT; UDI-DI (Product Code): 00840331260571 (THYROIDSHIELDOM8-R8TSBMT-MD ). \n\n14. Model Number: R8TSCBB; UDI-DI (Product Code): 00840331270525 (THYROIDSHIELD8-R8TSCBB-LG ), 00840331270532 (THYROIDSHIELD8-R8TSCBB-MD ), 00840331270549 (THYROIDSHIELD8-R8TSCBB-SM ). \n\n15. Model Number: R8TSCBN; UDI-DI (Product Code): 00840331260595 (THYROIDSHIELD8-R8TSCBN-LG ), 00840331260601 (THYROIDSHIELD8-R8TSCBN-MD ), 00840331260618 (THYROIDSHIELD8-R8TSCBN-SM ). \n\n16. Model Number: R8TSCBR; UDI-DI (Product Code): 00840331260625 (THYROIDSHIELD8-R8TSCBR-LG ), 00840331260632 (THYROIDSHIELD8-R8TSCBR-MD ), 00840331260649 (THYROIDSHIELD8-R8TSCBR-SM ). \n\n17. Model Number: R8TSCBS; UDI-DI (Product Code): 00840331270594 (THYROIDSHIELD8-R8TSCBS-MD ), 00840331270587 (THYROIDSHIELD8-R8TSCBS-SM ). \n\n18. Model Number: R8TSCBT; UDI-DI (Product Code): 00840331260656 (THYROIDSHIELD8-R8TSCBT-LG ), 00840331260663 (THYROIDSHIELD8-R8TSCBT-MD ), 00840331260670 (THYROIDSHIELD8-R8TSCBT-SM ). \n\n19. Model Number: R8TSCHB; UDI-DI (Product Code): 00840331270495 (THYROIDSHIELD8-R8TSCHB-LG ), 00840331270501 (THYROIDSHIELD8-R8TSCHB-MD ), 00840331270518 (THYROIDSHIELD8-R8TSCHB-SM ). \n\n20. Model Number: R8TSCHN; UDI-DI (Product Code): 00840331260687 (THYROIDSHIELD8-R8TSCHN-LG ), 00840331260694 (THYROIDSHIELD8-R8TSCHN-MD ), 00840331260700 (THYROIDSHIELD8-R8TSCHN-SM ). \n\n21. Model Number: R8TSCHR; UDI-DI (Product Code): 00840331260717 (THYROIDSHIELD8-R8TSCHR-LG ), 00840331260724 (THYROIDSHIELD8-R8TSCHR-MD ), 00840331260731 (THYROIDSHIELD8-R8TSCHR-SM ). \n\n22. Model Number: R8TSCHS; UDI-DI (Product Code): 00840331270563 (THYROIDSHIELD8-R8TSCHS-MD ), 00840331270556 (THYROIDSHIELD8-R8TSCHS-SM ). \n\n23. Model Number: R8TSCHT; UDI-DI (Product Code): 00840331260748 (THYROIDSHIELD8-R8TSCHT-LG ), 00840331260755 (THYROIDSHIELD8-R8TSCHT-MD ), 00840331260762 (THYROIDSHIELD8-R8TSCHT-SM ). \n\n24. Model Number: R8TSCMB; UDI-DI (Product Code): 00840331270464 (THYROIDSHIELDM8-R8TSCMB-LG ), 00840331270471 (THYROIDSHIELDM8-R8TSCMB-MD ), 00840331270488 (THYROIDSHIELDM8-R8TSCMB-SM ). \n\n25. Model Number: R8TSCMN; UDI-DI (Product Code): 00840331260786 (THYROIDSHIELDM8-R8TSCMN-MD ), 00840331260793 (THYROIDSHIELDM8-R8TSCMN-SM ). \n\n26. Model Number: R8TSCMR; UDI-DI (Product Code): 00840331260809 (THYROIDSHIELDM8-R8TSCMR-LG ), 00840331260816 (THYROIDSHIELDM8-R8TSCMR-MD ), 00840331260823 (THYROIDSHIELDM8-R8TSCMR-SM ). \n\n27. Model Number: R8TSCMS; UDI-DI (Product Code): 00840331260830 (THYROIDSHIELDM8-R8TSCMS-MD ), 00840331260847 (THYROIDSHIELDM8-R8TSCMS-SM ). \n\n28. Model Number: R8TSCMT; UDI-DI (Product Code): 00840331260854 (THYROIDSHIELDM8-R8TSCMT-LG ), 00840331260861 (THYROIDSHIELDM8-R8TSCMT-MD ), 00840331260878 (THYROIDSHIELDM8-R8TSCMT-SM ). \n\n29. Model Number: R8TSOBB; UDI-DI (Product Code): 00840331271430 (THYROIDSHIELDO8-R8TSOBB-MD ). \n\n30. Model Number: R8TSOBN; UDI-DI (Product Code): 00840331260892 (THYROIDSHIELDO8-R8TSOBN-MD ). \n\n31. Model Number: R8TSOBR; UDI-DI (Product Code): 00840331260922 (THYROIDSHIELDO8-R8TSOBR-MD ), 00840331260939 (THYROIDSHIELDO8-R8TSOBR-SM ). \n\n32. Model Number: R8TSOHB; UDI-DI (Product Code): 00840331260939 (THYROIDSHIELDO8-R8TSOHB-MD, THYROIDSHIELDO8-R8TSOHB-SM ). \n\n33. Model Number: R8TSOHR; UDI-DI (Product Code): 00840331261011 (THYROIDSHIELDO8-R8TSOHR-MD ), 00840331261028 (THYROIDSHIELDO8-R8TSOHR-SM ). \n\n34. Model Number: R8TSOHT; UDI-DI (Product Code): 00840331261035 (THYROIDSHIELDO8-R8TSOHT-LG ). \n\n35. Model Number: R8TSOMN; UDI-DI (Product Code): 00840331261080 (THYROIDSHIELDOM8-R8TSOMN-SM ). \n\n36. Model Number: R8TSOMR; UDI-DI (Product Code): 00840331261097 (THYROIDSHIELDOM8-R8TSOMR-LG ), 00840331261103 (THYROIDSHIELDOM8-R8TSOMR-MD ), 00840331261110 (THYROIDSHIELDOM8-R8TSOMR-SM ). \n\n37. Model Number: R8TSOMT; UDI-DI (Product Code): 00840331261141 (THYROIDSHIELDOM8-R8TSOMT-SM ). \n\n38. Model Number: R8TSSBB; UDI-DI (Product Code): 00840331270976 (THYROIDSHIELD8-R8TSSBB-LG ), 00840331270983 (THYROIDSHIELD8-R8TSSBB-MD ), 00840331270990 (THYROIDSHIELD8-R8TSSBB-SM ). \n\n39. Model Number: R8TSSBN ; UDI-DI (Product Code): 00840331261165 (THYROIDSHIELD8-R8TSSBN-MD ), 00840331261172 (THYROIDSHIELD8-R8TSSBN-SM ), None (THYROIDSHIELDP8-R8TSSBN-PD ). \n\n40. Model Number: R8TSSBR; UDI-DI (Product Code): 00840331261189 (THYROIDSHIELD8-R8TSSBR-LG ), 00840331261196 (THYROIDSHIELD8-R8TSSBR-MD ), 00840331261202 (THYROIDSHIELD8-R8TSSBR-SM ). \n\n41. Model Number: R8TSSBS; UDI-DI (Product Code): 00840331271041 (THYROIDSHIELD8-R8TSSBS-MD ), 00840331271034 (THYROIDSHIELD8-R8TSSBS-SM ). \n\n42. Model Number: R8TSSBT; UDI-DI (Product Code): 00840331261226 (THYROIDSHIELD8-R8TSSBT-MD ). \n\n43. Model Number: R8TSSHB; UDI-DI (Product Code): 00840331270952 (THYROIDSHIELD8-R8TSSHB-MD ), 00840331270969 (THYROIDSHIELD8-R8TSSHB-SM ). \n\n44. Model Number: R8TSSHN; UDI-DI (Product Code): 00840331261257 (THYROIDSHIELD8-R8TSSHN-MD ), 00840331261264 (THYROIDSHIELD8-R8TSSHN-SM ). \n\n45. Model Number: R8TSSHR; UDI-DI (Product Code): 00840331261271 (THYROIDSHIELD8-R8TSSHR-LG ), 00840331261288 (THYROIDSHIELD8-R8TSSHR-MD ), 00840331261295 (THYROIDSHIELD8-R8TSSHR-SM ). \n\n46. Model Number: R8TSSHS; UDI-DI (Product Code): 00840331271010 (THYROIDSHIELD8-R8TSSHS-MD ), 00840331271003 (THYROIDSHIELD8-R8TSSHS-SM ). \n\n47. Model Number: R8TSSHT; UDI-DI (Product Code): 00840331261318 (THYROIDSHIELD8-R8TSSHT-MD ), 00840331261325 (THYROIDSHIELD8-R8TSSHT-SM ). \n\n48. Model Number: R8TSSMB; UDI-DI (Product Code): 00840331270921 (THYROIDSHIELDM8-R8TSSMB-MD ), 00840331270938 (THYROIDSHIELDM8-R8TSSMB-SM ). \n\n49. Model Number: R8TSSMN; UDI-DI (Product Code): 00840331261349 (THYROIDSHIELDM8-R8TSSMN-MD ), 00840331261356 (THYROIDSHIELDM8-R8TSSMN-SM ). \n\n50. Model Number: R8TSSMR; UDI-DI (Product Code): 00840331261363 (THYROIDSHIELDM8-R8TSSMR-LG ), 00840331261370 (THYROIDSHIELDM8-R8TSSMR-MD ), 00840331261387 (THYROIDSHIELDM8-R8TSSMR-SM ). \n\n51. Model Number: R8TSSMS; UDI-DI (Product Code): (THYROIDSHIELDM8-R8TSSMS-MD ), (THYROIDSHIELDM8-R8TSSMS-SM ). \n\n52. Model Number: R8TSSMT; UDI-DI (Product Code): 00840331261400 (THYROIDSHIELDM8-R8TSSMT-MD ), 00840331261417 (THYROIDSHIELDM8-R8TSSMT-SM ). \n\n53. Model Number: R8TSVBN; UDI-DI (Product Code): 00840331261431 (THYROIDSHIELD8-R8TSVBN-MD ). \n\n54. Model Number: R8TSVBR; UDI-DI (Product Code): 00840331261462 (THYROIDSHIELD8-R8TSVBR-MD ), 00840331261479 (THYROIDSHIELD8-R8TSVBR-SM ). \n\n55. Model Number: R8TSVHR; UDI-DI (Product Code): 00840331261547 (THYROIDSHIELD8-R8TSVHR-LG ), 00840331261554 (THYROIDSHIELD8-R8TSVHR-MD ), 00840331261561 (THYROIDSHIELD8-R8TSVHR-SM ). \n\n56. Model Number: R8TSVHT; UDI-DI (Product Code): 00840331261561 (THYROIDSHIELD8-R8TSVHT-MD ), 00840331261622 (THYROIDSHIELD8-R8TSVHT-SM ). \n\n57. Model Number: R8TSVMN; UDI-DI (Product Code): 00840331261646 (THYROIDSHIELDM8-R8TSVMN-MD ), 00840331261653 (THYROIDSHIELDM8-R8TSVMN-SM ). \n\n58. Model Number: R8TSVMR; UDI-DI (Product Code): 00840331261660 (THYROIDSHIELDM8-R8TSVMR-LG ), 00840331261677 (THYROIDSHIELDM8-R8TSVMR-MD ), 00840331261684 (THYROIDSHIELDM8-R8TSVMR-SM ). \n\n59. Model Number: R8TSVMT; UDI-DI (Product Code): 00840331261738 (THYROIDSHIELDM8-R8TSVMT-MD ), 00840331261745 (THYROIDSHIELDM8-R8TSVMT-SM ). \n\n60. Model Number: S8TSBHR; UDI-DI (Product Code): 00840331296006 (THYROIDSHIELDO8-S8TSBHR-MD ). \n\n61. Model Number: S8TSBHT; UDI-DI (Product Code): 00840331264197 (THYROIDSHIELDO8-S8TSBHT-LG ). \n\n62. Model Number: S8TSBMB; UDI-DI (Product Code): 00840331264265 (THYROIDSHIELDOM8-S8TSBMB-MD ). \n\n63. Model Number: S8TSBMR; UDI-DI (Product Code): 00840331264265 (THYROIDSHIELDOM8-S8TSBMR-MD ), 00840331264272 (THYROIDSHIELDOM8-S8TSBMR-SM ). \n\n64. Model Number: S8TSCBB; UDI-DI (Product Code): 00840331270693 (THYROIDSHIELD8-S8TSCBB-SM ). \n\n65. Model Number: S8TSCBN; UDI-DI (Product Code): 00840331264326 (THYROIDSHIELD8-S8TSCBN-MD ). \n\n66. Model Number: S8TSCBR; UDI-DI (Product Code): 00840331264340 (THYROIDSHIELD8-S8TSCBR-LG ), 00840331264357 (THYROIDSHIELD8-S8TSCBR-MD ), 00840331264364 (THYROIDSHIELD8-S8TSCBR-SM ). \n\n67. Model Number: S8TSCBT; UDI-DI (Product Code): 00840331264388 (THYROIDSHIELD8-S8TSCBT-MD ), 00840331264395 (THYROIDSHIELD8-S8TSCBT-SM ). \n\n68. Model Number: S8TSCHN; UDI-DI (Product Code): 00840331264401 (THYROIDSHIELD8-S8TSCHN-LG ), 00840331264418 (THYROIDSHIELD8-S8TSCHN-MD ). \n\n69. Model Number: S8TSCHR; UDI-DI (Product Code): 00840331264432 (THYROIDSHIELD8-S8TSCHR-LG ), 00840331264449 (THYROIDSHIELD8-S8TSCHR-MD ), 00840331264456 (THYROIDSHIELD8-S8TSCHR-SM ). \n\n70. Model Number: S8TSCHT; UDI-DI (Product Code): 00840331264470 (THYROIDSHIELD8-S8TSCHT-MD ). \n\n71. Model Number: S8TSCMB; UDI-DI (Product Code): 00840331270617 (THYROIDSHIELDM8-S8TSCMB-LG ). \n\n72. Model Number: S8TSCMN; UDI-DI (Product Code): 00840331264517 (THYROIDSHIELDM8-S8TSCMN-SM ). \n\n73. Model Number: S8TSCMR; UDI-DI (Product Code): 00840331264524 (THYROIDSHIELDM8-S8TSCMR-LG ), 00840331264531 (THYROIDSHIELDM8-S8TSCMR-MD ), 00840331264548 (THYROIDSHIELDM8-S8TSCMR-SM ). \n\n74. Model Number: S8TSCMS; UDI-DI (Product Code): 00840331264555 (THYROIDSHIELDM8-S8TSCMS-MD ), 00840331264562 (THYROIDSHIELDM8-S8TSCMS-SM ). \n\n75. Model Number: S8TSCMT; UDI-DI (Product Code): 00840331264579 (THYROIDSHIELDM8-S8TSCMT-LG ), 00840331264586 (THYROIDSHIELDM8-S8TSCMT-MD ), 00840331264593 (THYROIDSHIELDM8-S8TSCMT-SM ). \n\n76. Model Number: S8TSOBR; UDI-DI (Product Code): 00840331264807 (THYROIDSHIELDO8-S8TSOBR-LG ), 00840331264784 (THYROIDSHIELDO8-S8TSOBR-SM ). \n\n77. Model Number: S8TSSBN; UDI-DI (Product Code): 00840331264883 (THYROIDSHIELD8-S8TSSBN-MD ). \n\n78. Model Number: S8TSSBR; UDI-DI (Product Code): 00840331264906 (THYROIDSHIELD8-S8TSSBR-LG ), 00840331264913 (THYROIDSHIELD8-S8TSSBR-MD ), 00840331264920 (THYROIDSHIELD8-S8TSSBR-SM ). \n\n79. Model Number: S8TSSBT; UDI-DI (Product Code): 00840331264944 (THYROIDSHIELD8-S8TSSBT-MD ). \n\n80. Model Number: S8TSSHR; UDI-DI (Product Code): 00840331264999 (THYROIDSHIELD8-S8TSSHR-LG ), 00840331265002 (THYROIDSHIELD8-S8TSSHR-MD ), 00840331265019 (THYROIDSHIELD8-S8TSSHR-SM ). \n\n81. Model Number: S8TSSHS; UDI-DI (Product Code): 00840331271164 (THYROIDSHIELD8-S8TSSHS-MD ). \n\n82. Model Number: S8TSSHT; UDI-DI (Product Code): 00840331265033 (THYROIDSHIELD8-S8TSSHT-MD ). \n\n83. Model Number: S8TSSMN; UDI-DI (Product Code): 00840331265064 (THYROIDSHIELDM8-S8TSSMN-MD ). \n\n84. Model Number: S8TSSMR; UDI-DI (Product Code): 00840331265088 (THYROIDSHIELDM8-S8TSSMR-LG ), 00840331265095 (THYROIDSHIELDM8-S8TSSMR-MD ), 00840331265101 (THYROIDSHIELDM8-S8TSSMR-SM ). \n\n85. Model Number: S8TSSMS; UDI-DI (Product Code): (THYROIDSHIELDM8-S8TSSMS-MD ). \n\n86. Model Number: S8TSSMT; UDI-DI (Product Code): 00840331265118 (THYROIDSHIELDM8-S8TSSMT-LG ), 00840331265132 (THYROIDSHIELDM8-S8TSSMT-SM ). \n\n87. Model Number: S8TSVBB; UDI-DI (Product Code): 00840331271799 (THYROIDSHIELD8-S8TSVBB-MD ). \n\n88. Model Number: S8TSVBR; UDI-DI (Product Code): 00840331265187 (THYROIDSHIELD8-S8TSVBR-MD ). \n\n89. Model Number: S8TSVHR; UDI-DI (Product Code): 00840331265279 (THYROIDSHIELD8-S8TSVHR-MD ), 00840331265286 (THYROIDSHIELD8-S8TSVHR-SM ). \n\n90. Model Number: S8TSVMR; UDI-DI (Product Code): 00840331265392 (THYROIDSHIELDM8-S8TSVMR-MD ), 00840331265408 (THYROIDSHIELDM8-S8TSVMR-SM ). \n\n91. Model Number: U8TSBBR; UDI-DI (Product Code): 00840331267853 (THYROIDSHIELDO8-U8TSBBR-SM ). \n\n92. Model Number: U8TSBMN; UDI-DI (Product Code): 00840331267990 (THYROIDSHIELDOM8-U8TSBMN-MD ). \n\n93. Model Number: U8TSBMR; UDI-DI (Product Code): 00840331268010 (THYROIDSHIELDOM8-U8TSBMR-LG ), 00840331268027 (THYROIDSHIELDOM8-U8TSBMR-MD ). \n\n94. Model Number: U8TSCBN; UDI-DI (Product Code): 00840331268089 (THYROIDSHIELD8-U8TSCBN-MD ). \n\n95. Model Number: U8TSCBR; UDI-DI (Product Code): 00840331268102 (THYROIDSHIELD8-U8TSCBR-LG ), 00840331268119 (THYROIDSHIELD8-U8TSCBR-MD ), 00840331268126 (THYROIDSHIELD8-U8TSCBR-SM ). \n\n96. Model Number: U8TSCBT; UDI-DI (Product Code): 00840331268140 (THYROIDSHIELD8-U8TSCBT-MD ). \n\n97. Model Number: U8TSCHR; UDI-DI (Product Code): 00840331268201 (THYROIDSHIELD8-U8TSCHR-MD ), 00840331268218 (THYROIDSHIELD8-U8TSCHR-SM ). \n\n98. Model Number: U8TSCMR; UDI-DI (Product Code): 00840331268294 (THYROIDSHIELDM8-U8TSCMR-MD ), 00840331268300 (THYROIDSHIELDM8-U8TSCMR-SM ). \n\n99. Model Number: U8TSCMT; UDI-DI (Product Code): 00840331268324 (THYROIDSHIELDM8-U8TSCMT-MD ), 00840331268331 (THYROIDSHIELDM8-U8TSCMT-SM ). \n\n100. Model Number: U8TSOMR; UDI-DI (Product Code): 00840331268560 (THYROIDSHIELDOM8-U8TSOMR-MD ). \n\n101. Model Number: U8TSSBN; UDI-DI (Product Code): 00840331268621 (THYROIDSHIELD8-U8TSSBN-MD ). \n\n102. Model Number: U8TSSBR; UDI-DI (Product Code): 00840331268652 (THYROIDSHIELD8-U8TSSBR-MD ). \n\n103. Model Number: U8TSSHN; UDI-DI (Product Code): 00840331268713 (THYROIDSHIELD8-U8TSSHN-MD ). \n\n104. Model Number: U8TSSHR; UDI-DI (Product Code): 00840331268737 (THYROIDSHIELD8-U8TSSHR-LG ), 00840331268744 (THYROIDSHIELD8-U8TSSHR-MD ). \n\n105. Model Number: U8TSSMR; UDI-DI (Product Code): 00840331268829 (THYROIDSHIELDM8-U8TSSMR-LG ), 00840331268836 (THYROIDSHIELDM8-U8TSSMR-MD ), 00840331268843 (THYROIDSHIELDM8-U8TSSMR-SM ). \n\n106. Model Number: U8TSSMS; UDI-DI (Product Code): None (THYROIDSHIELDM8-U8TSSMS-SM ). \n\n107. Model Number: U8TSSMT; UDI-DI (Product Code): 00840331268867 (THYROIDSHIELDM8-U8TSSMT-MD ), 00840331268874 (THYROIDSHIELDM8-U8TSSMT-SM ). \n\n108. Model Number: U8TSVMR; UDI-DI (Product Code): 00840331269130 (THYROIDSHIELDM8-U8TSVMR-MD ), 00840331269147 (THYROIDSHIELDM8-U8TSVMR-SM ).", "firm_fei_number": "1000120804", "recalling_firm": "Burlington Medical, LLC", "address_1": "3 Elmhurst St", "address_2": "Suite 112", "city": "Newport News", "state": "VA", "postal_code": "23603-1137", "additional_info_contact": "Roger West\n757-8888994", "reason_for_recall": "Potential for attenuation degradation over time, decreasing the lifespan.", "root_cause_description": "Process change control", "action": "Burlington Medical notified consignees on about 02/11/2026 via \"URGENT - FIELD SAFETY NOTICE (FSN)\" letter. Consignees were instructed to ensure all users of the specific Burlington Medical radiation protection garments made aware of this Recall Notice, review inventory for affected units, arrange for the return of those affected units for proper disposal, and complete and return the Recall Response Form. Consignees were also instructed to notify appropriate individuals within your organization and to any organization where the potentially affected devices were transferred or sold.", "product_quantity": "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.", "openfda": { "k_number": [ "K770407" ], "registration_number": [ "3015058854", "3020118", "9616872", "3008352964", "3017103765", "3013269506", "3016766901", "1834183", "2433012", "3014819517", "3034669683", "3008381089", "1218386", "9680411", "3016733683", "3045058049", "3027815", "3038632739", "9680506", "3007479164", "3007369190", "3007069733", "9680934", "3026030534", "3017158347", "3010198795", "3004980986", "3034629649", "3007791604", "3016704566", "3024088964", "3013846070", "2431224", "3031184338", "3006535976", "3017299798", "3008496560", "3016452400", "3005621808", "3008062466", "2024351", "3037040712", "3002532594", "3006210673", "3014314985", "3016171961", "1219113", "3003965134", "3017952343", "3023265420", "3004168759", "3025001668", "1222742", "3038282968", "3018269545", "3014610488", "3016968725", "3015384814", "2183301", "3011344631", "3010374972", "3016649599", "1063300", "3011529314", "2024312", "3009233038", "3011434305", "3010147274", "3006897996", "1053541", "3043648115", "3011526299", "3009222501", "3015416207", "3016758972", "3017385563", "3005257704", "3010864832", "3005176727", "3033011342" ], "fei_number": [ "3015058854", "3020118", "3008352964", "3017103765", "3013269506", "3016766901", "2433012", "3002897187", "3014819517", "3034669683", "3008381089", "3010862763", "1218386", "3016733683", "3045058049", "3038632739", "3007369190", "3002939620", "3007069733", "3026030534", "3017158347", "3010198795", "3004980986", "3034629649", "1000160424", "3007791604", "3006993165", "3016704566", "3024088964", "3013846070", "2431224", "3031184338", "3006535976", "3017299798", "3008496560", "3016452400", "3005621808", "3008062466", "2024351", "3037040712", "3002532594", "3006210673", "3014314985", "3016171961", "3008205331", "1219113", "3003965134", "3017952343", "3023265420", "1000488948", "3004168759", "3025001668", "3038282968", "3010322103", "3018269545", "3014610488", "3016968725", "3015384814", "2183301", "3011344631", "3010374972", "3016649599", "1000127185", "3011529314", "2024312", "3009233038", "3011434305", "3010147274", "3006897996", "1053541", "1000120804", "3043648115", "3011526299", "3009222501", "3015416207", "3016758972", "3017385563", "3005257704", "3005176727", "3033011342" ], "device_name": "Apron, Protective", "medical_specialty_description": "Radiology", "regulation_number": "892.6500", "device_class": "1" } } ] }