FDA event 98415 · Recall Observatory

device · product 1 of 13

Burlington Medical, Thyroid Shield.

Z-1753-2026

Recall number: Z-1753-2026
Initiated: February 11, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Burlington Medical, LLC
Quantity: 41,962 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for attenuation degradation over time, decreasing the lifespan.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for attenuation degradation over time, decreasing the lifespan.

Code information

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 ).

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.

device · product 2 of 13

Burlington Medical, Vest

Z-1754-2026

Recall number: Z-1754-2026
Initiated: February 11, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Burlington Medical, LLC
Quantity: 15,438 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for attenuation degradation over time, decreasing the lifespan.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for attenuation degradation over time, decreasing the lifespan.

Code information

All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: C8PVEST; UDI-DI (Product Code): 00840331297652 (VESTC18-C8PVEST-2XM ), 00840331297652 (VESTC8-C8PVEST-LF ), 00840331297652 (VESTC8-C8PVEST-LM ), 00840331297652 (VESTC8-C8PVEST-MF ), 00840331297652 (VESTC8-C8PVEST-MM ), 00840331297652 (VESTC8-C8PVEST-SF ), 00840331297652 (VESTC8-C8PVEST-SM ), 00840331297652 (VESTC8-C8PVEST-XLM ), 00840331297652 (VESTT18-C8PVEST-LF ), 00840331297652 (VESTT18-C8PVEST-LM ), 00840331297652 (VESTT18-C8PVEST-MM ), 00840331297652 (VESTT18-C8PVEST-PLUS ), 00840331297652 (VESTT18-C8PVEST-SM ), 00840331297652 (VESTT28-C8PVEST-3XM ), 00840331297652 (VESTT28-C8PVEST-4XM ), 00840331297652 (VESTT28-C8PVEST-5XM ). 2. Model Number: C8VEST; UDI-DI (Product Code): 00840331297645 (VESTC18-C8VEST-2XM ), 00840331297645 (VESTC8-C8VEST-LF ), 00840331297645 (VESTC8-C8VEST-LM ), 00840331297645 (VESTC8-C8VEST-MF ), 00840331297645 (VESTC8-C8VEST-MM ), 00840331297645 (VESTC8-C8VEST-PLUS ), 00840331297645 (VESTC8-C8VEST-SF ), 00840331297645 (VESTC8-C8VEST-SM ), 00840331297645 (VESTC8-C8VEST-XLF ), 00840331297645 (VESTC8-C8VEST-XLM ), 00840331297645 (VESTC8-C8VEST-XSF ), 00840331297645 (VESTT18-C8VEST-LM ), 00840331297645 (VESTT18-C8VEST-MM ), 00840331297645 (VESTT18-C8VEST-SM ), 00840331297645 (VESTT18-C8VEST-XLM ), 00840331297645 (VESTT18-C8VEST-XSM ), 00840331297645 (VESTT28-C8VEST-2XM ), 00840331297645 (VESTT28-C8VEST-4XF ). 3. Model Number: R8FVEST; UDI-DI (Product Code): 00840331259520 (VESTC18-R8FVEST-2XF ), 00840331259537 (VESTC18-R8FVEST-2XM ), 00840331259551 (VESTC18-R8FVEST-3XM ), 00840331259568 (VESTC8-R8FVEST-LF ), 00840331259575 (VESTC8-R8FVEST-LM ), 00840331259582 (VESTC8-R8FVEST-MF ), 00840331259599 (VESTC8-R8FVEST-MM ), 00840331259605 (VESTC8-R8FVEST-PLUS ), 00840331259612 (VESTC8-R8FVEST-SF ), 00840331259629 (VESTC8-R8FVEST-SM ), 00840331259636 (VESTC8-R8FVEST-XLF ), 00840331259643 (VESTC8-R8FVEST-XLM ), 00840331259650 (VESTC8-R8FVEST-XSF ), 00840331269741 (VESTT18-R8FVEST-LF ), 00840331269758 (VESTT18-R8FVEST-LM ), 00840331269741 (VESTT18-R8FVEST-MF ), 00840331269758 (VESTT18-R8FVEST-MM ), 00840331269741 (VESTT18-R8FVEST-PLUS ), 00840331269741 (VESTT18-R8FVEST-SF ), 00840331269758 (VESTT18-R8FVEST-SM ), 00840331269741 (VESTT18-R8FVEST-XLF ), 00840331269758 (VESTT18-R8FVEST-XLM ), 00840331269758 (VESTT18-R8FVEST-XSM ), 00840331269741 (VESTT28-R8FVEST-2XF ), 00840331269758 (VESTT28-R8FVEST-2XM ), 00840331269741 (VESTT28-R8FVEST-3XF ), 00840331269758 (VESTT28-R8FVEST-3XM ), 00840331269741 (VESTT28-R8FVEST-4XF ), 00840331269758 (VESTT28-R8FVEST-4XM ), 00840331269741 (VESTT28-R8FVEST-5XF ), 00840331269758 (VESTT28-R8FVEST-5XM ), 00840331269741 (VESTT38-R8FVEST-6XF ), 00840331269758 (VESTT38-R8FVEST-6XM ), 00840331269741 (VESTT38-R8FVEST-8XF ), 00840331269758 (VESTT38-R8FVEST-8XM ), None (IVESTC8-R8FVEST-MFR ), None (IVESTC8-R8FVEST-MML ), None (IVESTC8-R8FVEST-LFL ), None (IVESTC8-R8FVEST-LFR ), None (IVESTC8-R8FVEST-LML ), None (IVESTC8-R8FVEST-MMR ), None (IVESTC8-R8FVEST-PLUSL ), None (IVESTC8-R8FVEST-SFR ), None (IVESTC8-R8FVEST-SFS ), None (IVESTC8-R8FVEST-SMR ), None (IVESTC8-R8FVEST-SMS ), None (IVESTC8-R8FVEST-XLML ), None (IVESTC8-R8FVEST-XSFS ), None (IVESTC8-R8FVEST-MMXL ), None (IVESTC8-R8FVEST-XLMXL ), None (IVESTC8-R8FVEST-LMR ), None (IVESTC8-R8FVEST-XSFR ), None (IVESTC8-R8FVEST-XSMR ). 4. Model Number: R8PVEST; UDI-DI (Product Code): None (IVESTC8-R8PVEST-LMR ), None (IVESTC8-R8PVEST-SMR ), 00840331259841 (VESTC18-R8PVEST-2XF ), 00840331259858 (VESTC18-R8PVEST-2XM ), 00840331259865 (VESTC18-R8PVEST-3XF ), 00840331259872 (VESTC18-R8PVEST-3XM ), 00840331259889 (VESTC8-R8PVEST-LF ), 00840331259896 (VESTC8-R8PVEST-LM ), 00840331259902 (VESTC8-R8PVEST-MF ), 00840331259919 (VESTC8-R8PVEST-MM ), 00840331259926 (VESTC8-R8PVEST-PLUS ), 00840331259933 (VESTC8-R8PVEST-SF ), 00840331259940 (VESTC8-R8PVEST-SM ), 00840331259957 (VESTC8-R8PVEST-XLF ), 00840331259964 (VESTC8-R8PVEST-XLM ), 00840331259971 (VESTC8-R8PVEST-XSF ), 00840331259988 (VESTC8-R8PVEST-XSM ), 00840331269680 (VESTT18-R8PVEST-LF ), 00840331269697 (VESTT18-R8PVEST-LM ), 00840331269680 (VESTT18-R8PVEST-MF ), 00840331269697 (VESTT18-R8PVEST-MM ), 00840331269680 (VESTT18-R8PVEST-PLUS ), 00840331269680 (VESTT18-R8PVEST-SF ), 00840331269697 (VESTT18-R8PVEST-SM ), 00840331269680 (VESTT18-R8PVEST-XLF ), 00840331269697 (VESTT18-R8PVEST-XLM ), 00840331269697 (VESTT18-R8PVEST-XSM ), 00840331269680 (VESTT28-R8PVEST-2XF ), 00840331269697 (VESTT28-R8PVEST-2XM ), 00840331269680 (VESTT28-R8PVEST-3XF ), 00840331269697 (VESTT28-R8PVEST-3XM ), 00840331269680 (VESTT28-R8PVEST-4XF ), 00840331269697 (VESTT28-R8PVEST-4XM ), 00840331269680 (VESTT28-R8PVEST-5XF ), 00840331269697 (VESTT28-R8PVEST-5XM ), 00840331269680 (VESTT38-R8PVEST-6XF ), 00840331269697 (VESTT38-R8PVEST-6XM ), 00840331269680 (VESTT38-R8PVEST-7XF ), 00840331269697 (VESTT38-R8PVEST-7XM ), 00840331269680 (VESTT38-R8PVEST-8XF ), 00840331269697 (VESTT38-R8PVEST-8XM ), None (IVESTC8-R8PVEST-LFR ), None (IVESTC8-R8PVEST-MFL ), None (IVESTC8-R8PVEST-MFR ), None (IVESTC8-R8PVEST-MML ), None (IVESTC8-R8PVEST-MMR ), None (IVESTC8-R8PVEST-SFR ), None (IVESTC8-R8PVEST-XSFR ), None (IVESTC8-R8PVEST-2XFR ), None (IVESTC8-R8PVEST-LML ), None (IVESTC8-R8PVEST-LMXL ), None (IVESTC8-R8PVEST-MFS ), None (IVESTC8-R8PVEST-SFL ), None (IVESTC8-R8PVEST-SFS ), None (IVESTC8-R8PVEST-XLFL ), None (IVESTC8-R8PVEST-XLMR ). 5. Model Number: R8QVEST; UDI-DI (Product Code): 00840331260076 (QVESTC18-R8QVEST-LF ), 00840331260083 (QVESTC18-R8QVEST-MF ), None (QVESTC18-R8QVEST-PLUS ), 00840331260106 (QVESTC18-R8QVEST-SF ), 00840331260113 (QVESTC18-R8QVEST-XLF ), 00840331260007 (QVESTC28-R8QVEST-2XF ), 00840331269802 (QVESTT18-R8QVEST-LF ), 00840331269802 (QVESTT18-R8QVEST-MF ), 00840331269802 (QVESTT18-R8QVEST-PLUS ), 00840331269802 (QVESTT18-R8QVEST-SF ), 00840331269802 (QVESTT18-R8QVEST-XLF ), 00840331269802 (QVESTT28-R8QVEST-2XF ), 00840331269802 (QVESTT28-R8QVEST-3XF ), 00840331269802 (QVESTT28-R8QVEST-4XF ), 00840331269802 (QVESTT28-R8QVEST-5XF ), 00840331269802 (QVESTT38-R8QVEST-8XF ), None (IQVESTC8-R8QVEST-SFR ), 00840331260120 (QVESTC18-R8QVEST-XSF ), None (IQVESTC8-R8QVEST-MFR). 6. Model Number: R8VEST; UDI-DI (Product Code): 00840331261752 (VESTC18-R8VEST-2XF ), 00840331261769 (VESTC18-R8VEST-2XM ), 00840331261776 (VESTC18-R8VEST-3XF ), 00840331261783 (VESTC18-R8VEST-3XM ), 00840331261790 (VESTC8-R8VEST-LF ), 00840331261806 (VESTC8-R8VEST-LM ), 00840331261813 (VESTC8-R8VEST-MF ), 00840331261820 (VESTC8-R8VEST-MM ), 00840331261837 (VESTC8-R8VEST-PLUS ), 00840331261844 (VESTC8-R8VEST-SF ), 00840331261851 (VESTC8-R8VEST-SM ), 00840331261868 (VESTC8-R8VEST-XLF ), 00840331261875 (VESTC8-R8VEST-XLM ), 00840331261882 (VESTC8-R8VEST-XSF ), 00840331261899 (VESTC8-R8VEST-XSM ), 00840331261790 (VESTS8-R8VEST-LF ), 00840331261806 (VESTS8-R8VEST-LM ), 00840331261813 (VESTS8-R8VEST-MF ), 00840331261820 (VESTS8-R8VEST-MM ), 00840331261837 (VESTS8-R8VEST-PLUS ), 00840331261844 (VESTS8-R8VEST-SF ), 00840331261851 (VESTS8-R8VEST-SM ), 00840331261868 (VESTS8-R8VEST-XLF ), 00840331261875 (VESTS8-R8VEST-XLM ), 00840331269628 (VESTT18-R8VEST-LF ), 00840331269635 (VESTT18-R8VEST-LM ), 00840331269628 (VESTT18-R8VEST-MF ), 00840331269635 (VESTT18-R8VEST-MM ), 00840331269628 (VESTT18-R8VEST-PLUS ), 00840331269628 (VESTT18-R8VEST-SF ), 00840331269635 (VESTT18-R8VEST-SM ), 00840331269628 (VESTT18-R8VEST-XLF ), 00840331269635 (VESTT18-R8VEST-XLM ), 00840331269628 (VESTT18-R8VEST-XSF ), 00840331269635 (VESTT18-R8VEST-XSM ), 00840331269628 (VESTT28-R8VEST-2XF ), 00840331269635 (VESTT28-R8VEST-2XM ), 00840331269628 (VESTT28-R8VEST-3XF ), 00840331269635 (VESTT28-R8VEST-3XM ), 00840331269628 (VESTT28-R8VEST-4XF ), 00840331269635 (VESTT28-R8VEST-4XM ), 00840331269628 (VESTT28-R8VEST-5XF ), 00840331269635 (VESTT28-R8VEST-5XM ), 00840331269628 (VESTT38-R8VEST-6XF ), 00840331269635 (VESTT38-R8VEST-6XM ), 00840331269628 (VESTT38-R8VEST-7XF ), 00840331269635 (VESTT38-R8VEST-7XM ), 00840331269628 (VESTT38-R8VEST-8XF ), 00840331269635 (VESTT38-R8VEST-8XM ), None (IVESTC8-R8VEST-LFR ), None (IVESTC8-R8VEST-LMR ), None (IVESTC8-R8VEST-MMR ), None (IVESTC8-R8VEST-SMS ), None (IVESTC8-R8VEST-MFR ), None (IVESTC8-R8VEST-SFR), None (IVESTC8-R8VEST-LML ), None (IVESTC8-R8VEST-SMR ). 7. Model Number: R8ZVEST; UDI-DI (Product Code): 00840331262063 (ZVESTC18-R8ZVEST-LM), 00840331262087 (ZVESTC18-R8ZVEST-MM), 00840331262087 (ZVESTC18-R8ZVEST-SF), 00840331262148 (ZVESTC18-R8ZVEST-XSF), 00840331269840 (ZVESTT18-R8ZVEST-LM), 00840331269833 (ZVESTT18-R8ZVEST-PLUS), 00840331269840 (ZVESTT28-R8ZVEST-2XM), 00840331269833 (ZVESTT28-R8ZVEST-3XF), None (IZVESTC8-R8ZVEST-LFR). 8. Model Number: S8FVEST; UDI-DI (Product Code): 00840331263275 (VESTC18-S8FVEST-2XF ), 00840331263305 (VESTC18-S8FVEST-3XM ), 00840331263312 (VESTC8-S8FVEST-LF ), 00840331263329 (VESTC8-S8FVEST-LM ), 00840331263336 (VESTC8-S8FVEST-MF ), 00840331263343 (VESTC8-S8FVEST-MM ), 00840331263350 (VESTC8-S8FVEST-PLUS ), 00840331263367 (VESTC8-S8FVEST-SF ), 00840331263374 (VESTC8-S8FVEST-SM ), 00840331263381 (VESTC8-S8FVEST-XLF ), 00840331263398 (VESTC8-S8FVEST-XLM ), 00840331269765 (VESTT18-S8FVEST-LF ), 00840331269772 (VESTT18-S8FVEST-LM ), 00840331269765 (VESTT18-S8FVEST-MF ), 00840331269772 (VESTT18-S8FVEST-MM ), 00840331269765 (VESTT18-S8FVEST-PLUS ), 00840331269765 (VESTT18-S8FVEST-SF ), 00840331269772 (VESTT18-S8FVEST-SM ), 00840331269765 (VESTT18-S8FVEST-XLF ), 00840331269772 (VESTT18-S8FVEST-XLM ), 00840331269772 (VESTT28-S8FVEST-2XM ), 00840331269765 (VESTT28-S8FVEST-3XF ), 00840331269772 (VESTT28-S8FVEST-3XM ), 00840331269765 (VESTT28-S8FVEST-4XF ), 00840331269772 (VESTT28-S8FVEST-4XM ), 00840331269765 (VESTT28-S8FVEST-5XF ), 00840331269772 (VESTT28-S8FVEST-5XM ), 00840331269765 (VESTT38-S8FVEST-6XF ), 00840331269772 (VESTT38-S8FVEST-6XM ), 00840331269765 (VESTT38-S8FVEST-7XF ), 00840331269765 (VESTT38-S8FVEST-8XF ). 9. Model Number: S8PVEST; UDI-DI (Product Code): 00840331263596 (VESTC18-S8PVEST-2XF ), 00840331263602 (VESTC18-S8PVEST-2XM ), 00840331263633 (VESTC8-S8PVEST-LF ), 00840331263640 (VESTC8-S8PVEST-LM ), 00840331263657 (VESTC8-S8PVEST-MF ), 00840331263664 (VESTC8-S8PVEST-MM ), 00840331263671 (VESTC8-S8PVEST-PLUS ), 00840331263688 (VESTC8-S8PVEST-SF ), 00840331263695 (VESTC8-S8PVEST-SM ), 00840331263701 (VESTC8-S8PVEST-XLF ), 00840331263718 (VESTC8-S8PVEST-XLM ), 00840331269703 (VESTT18-S8PVEST-LF ), 00840331269710 (VESTT18-S8PVEST-LM ), 00840331269703 (VESTT18-S8PVEST-MF ), 00840331269710 (VESTT18-S8PVEST-MM ), 00840331269703 (VESTT18-S8PVEST-PLUS ), 00840331269703 (VESTT18-S8PVEST-SF ), 00840331269710 (VESTT18-S8PVEST-SM ), 00840331269703 (VESTT18-S8PVEST-XLF ), 00840331269710 (VESTT18-S8PVEST-XLM ), 00840331269710 (VESTT18-S8PVEST-XSM ), 00840331269703 (VESTT28-S8PVEST-2XF ), 00840331269710 (VESTT28-S8PVEST-2XM ), 00840331269703 (VESTT28-S8PVEST-3XF ), 00840331269710 (VESTT28-S8PVEST-3XM ), 00840331269703 (VESTT28-S8PVEST-4XF ), 00840331269710 (VESTT28-S8PVEST-4XM ), 00840331269703 (VESTT28-S8PVEST-5XF ), 00840331269710 (VESTT28-S8PVEST-5XM ), 00840331269703 (VESTT38-S8PVEST-6XF ), 00840331269710 (VESTT38-S8PVEST-6XM ), 00840331269703 (VESTT38-S8PVEST-7XF ), 00840331269710 (VESTT38-S8PVEST-7XM ), 00840331269703 (VESTT38-S8PVEST-8XF ), 00840331269710 (VESTT38-S8PVEST-8XM ). 10. Model Number: S8QVEST; UDI-DI (Product Code): 00840331263794 (QVESTC18-S8QVEST-LF ), 00840331263800 (QVESTC18-S8QVEST-MF ), 00840331263817 (QVESTC18-S8QVEST-PLUS ), 00840331263824 (QVESTC18-S8QVEST-SF ), 00840331263831 (QVESTC18-S8QVEST-XLF ), 00840331269819 (QVESTT18-S8QVEST-LF ), 00840331269819 (QVESTT18-S8QVEST-MF ), 00840331269819 (QVESTT18-S8QVEST-PLUS ), 00840331269819 (QVESTT18-S8QVEST-XLF ), 00840331269819 (QVESTT28-S8QVEST-2XF ), 00840331269819 (QVESTT28-S8QVEST-3XF ), 00840331269819 (QVESTT28-S8QVEST-4XF ), 00840331269819 (QVESTT28-S8QVEST-5XF ), 00840331269819 (QVESTT38-S8QVEST-6XF ), 00840331269819 (QVESTT38-S8QVEST-7XF ). 11. Model Number: S8VEST; UDI-DI (Product Code): 00840331265477 (VESTC18-S8VEST-2XF ), 00840331265484 (VESTC18-S8VEST-2XM ), 00840331265491 (VESTC18-S8VEST-3XF ), 00840331265514 (VESTC8-S8VEST-LF ), 00840331265521 (VESTC8-S8VEST-LM ), 00840331265538 (VESTC8-S8VEST-MF ), 00840331265545 (VESTC8-S8VEST-MM ), 00840331265552 (VESTC8-S8VEST-PLUS ), 00840331265569 (VESTC8-S8VEST-SF ), 00840331265576 (VESTC8-S8VEST-SM ), 00840331265583 (VESTC8-S8VEST-XLF ), 00840331265590 (VESTC8-S8VEST-XLM ), 00840331265606 (VESTC8-S8VEST-XSF ), 00840331265613 (VESTC8-S8VEST-XSM ), 00840331265514 (VESTS8-S8VEST-LF ), 00840331265521 (VESTS8-S8VEST-LM ), 00840331265538 (VESTS8-S8VEST-MF ), 00840331265545 (VESTS8-S8VEST-MM ), 00840331265569 (VESTS8-S8VEST-SF ), 00840331265576 (VESTS8-S8VEST-SM ), 00840331265583 (VESTS8-S8VEST-XLF ), 00840331265590 (VESTS8-S8VEST-XLM ), 00840331269642 (VESTT18-S8VEST-LF ), 00840331269659 (VESTT18-S8VEST-LM ), 00840331269642 (VESTT18-S8VEST-MF ), 00840331269659 (VESTT18-S8VEST-MM ), 00840331269642 (VESTT18-S8VEST-PLUS ), 00840331269642 (VESTT18-S8VEST-SF ), 00840331269659 (VESTT18-S8VEST-SM ), 00840331269642 (VESTT18-S8VEST-XLF ), 00840331269659 (VESTT18-S8VEST-XLM ), 00840331269642 (VESTT18-S8VEST-XSF ), 00840331269659 (VESTT18-S8VEST-XSM ), 00840331269642 (VESTT28-S8VEST-2XF ), 00840331269659 (VESTT28-S8VEST-2XM ), 00840331269642 (VESTT28-S8VEST-3XF ), 00840331269659 (VESTT28-S8VEST-3XM ), 00840331269642 (VESTT28-S8VEST-4XF ), 00840331269659 (VESTT28-S8VEST-4XM ), 00840331269642 (VESTT28-S8VEST-5XF ), 00840331269659 (VESTT28-S8VEST-5XM ), 00840331269642 (VESTT38-S8VEST-6XF ), 00840331269659 (VESTT38-S8VEST-6XM ), 00840331269642 (VESTT38-S8VEST-7XF ), 00840331269659 (VESTT38-S8VEST-7XM ), 00840331269642 (VESTT38-S8VEST-8XF ), 00840331269659 (VESTT38-S8VEST-8XM ), None (IVESTC8-S8VEST-SMS ), None (IVESTC8-S8VEST-LMR ), None (IVESTC8-S8VEST-MMR ). 12. Model Number: S8ZVEST; UDI-DI (Product Code): 00840331265781 (ZVESTC18-S8ZVEST-LM ), 00840331265804 (ZVESTC18-S8ZVEST-MM ), 00840331269864 (ZVESTT18-S8ZVEST-LF ), 00840331269864 (ZVESTT18-S8ZVEST-PLUS ). 13. Model Number: U8FVEST; UDI-DI (Product Code): 00840331267044 (VESTC8-U8FVEST-LF ), 00840331267051 (VESTC8-U8FVEST-LM ), 00840331267075 (VESTC8-U8FVEST-MM ), 00840331267099 (VESTC8-U8FVEST-SF ), 00840331267105 (VESTC8-U8FVEST-SM ), 00840331267112 (VESTC8-U8FVEST-XLF ), 00840331267136 (VESTC8-U8FVEST-XSF ), 00840331269796 (VESTT18-U8FVEST-LM ), 00840331269789 (VESTT18-U8FVEST-PLUS ), 00840331269789 (VESTT18-U8FVEST-XLF ), 00840331269796 (VESTT28-U8FVEST-2XM ), 00840331269789 (VESTT28-U8FVEST-3XF ), 00840331269796 (VESTT28-U8FVEST-3XM ), 00840331269789 (VESTT38-U8FVEST-6XF ), None (IVESTC8-U8FVEST-LML ), None (IVESTC8-U8FVEST-LMR ), None (IVESTC8-U8FVEST-MFR ), None (IVESTC8-U8FVEST-MMR ), None (IVESTC8-U8FVEST-SFR ), None (IVESTC8-U8FVEST-XLML ), None (IVESTC8-U8FVEST-XLMR ). 14. Model Number: U8PVEST; UDI-DI (Product Code): 00840331267013 (VESTC18-U8PVEST-2XM ), 00840331267365 (VESTC8-U8PVEST-LF ), 00840331267372 (VESTC8-U8PVEST-LM ), 00840331267389 (VESTC8-U8PVEST-MF ), 00840331267396 (VESTC8-U8PVEST-MM ), 00840331267402 (VESTC8-U8PVEST-PLUS ), 00840331267419 (VESTC8-U8PVEST-SF ), 00840331267433 (VESTC8-U8PVEST-XLF ), 00840331267440 (VESTC8-U8PVEST-XLM ), 00840331267464 (VESTC8-U8PVEST-XSM ), 00840331269727 (VESTT18-U8PVEST-LF ), 00840331269734 (VESTT18-U8PVEST-LM ), 00840331269727 (VESTT18-U8PVEST-MF ), 00840331269734 (VESTT18-U8PVEST-MM ), 00840331269727 (VESTT18-U8PVEST-PLUS ), 00840331269727 (VESTT18-U8PVEST-SF ), 00840331269734 (VESTT18-U8PVEST-SM ), 00840331269727 (VESTT18-U8PVEST-XLF ), 00840331269734 (VESTT18-U8PVEST-XLM ), 00840331269734 (VESTT18-U8PVEST-XSM ), 00840331269727 (VESTT28-U8PVEST-2XF ), 00840331269734 (VESTT28-U8PVEST-2XM ), 00840331269727 (VESTT28-U8PVEST-3XF ), 00840331269734 (VESTT28-U8PVEST-3XM ), 00840331269734 (VESTT28-U8PVEST-4XF ), 00840331269727 (VESTT28-U8PVEST-4XF ), 00840331269734 (VESTT28-U8PVEST-4XM ), 00840331269727 (VESTT28-U8PVEST-5XF ), 00840331269734 (VESTT28-U8PVEST-5XM ), 00840331269727 (VESTT38-U8PVEST-6XF ), None (IVESTC8-U8PVEST-2XMR ), None (IVESTC8-U8PVEST-LMR ), None (IVESTC8-U8PVEST-MFR ), None (IVESTC8-U8PVEST-MMR ), None (IVESTC8-U8PVEST-SFR ), None (IVESTC8-U8PVEST-SMR ). 15. Model Number: U8QVEST; UDI-DI (Product Code): 00840331267556 (QVESTC18-U8QVEST-LF ), 00840331267563 (QVESTC18-U8QVEST-MF ), 00840331267594 (QVESTC18-U8QVEST-XLF ), 00840331267525 (QVESTC28-U8QVEST-3XF ), 00840331269826 (QVESTT18-U8QVEST-LF ), 00840331269826 (QVESTT18-U8QVEST-PLUS ), 00840331269826 (QVESTT28-U8QVEST-3XF ), 00840331296136 (QVESTT38-U8QVEST-8XF ), None (IQVESTC8-U8QVEST-LFR ). 16. Model Number: U8VEST; UDI-DI (Product Code): 00840331269215 (VESTC18-U8VEST-2XF ), 00840331269222 (VESTC18-U8VEST-2XM ), 00840331269253 (VESTC8-U8VEST-LF ), 00840331269260 (VESTC8-U8VEST-LM ), 00840331269277 (VESTC8-U8VEST-MF ), 00840331269284 (VESTC8-U8VEST-MM ), 00840331269291 (VESTC8-U8VEST-PLUS ), 00840331269307 (VESTC8-U8VEST-SF ), 00840331269314 (VESTC8-U8VEST-SM ), 00840331269321 (VESTC8-U8VEST-XLF ), 00840331269338 (VESTC8-U8VEST-XLM ), 00840331269352 (VESTC8-U8VEST-XSM ), 00840331269260 (VESTS8-U8VEST-LM ), 00840331269277 (VESTS8-U8VEST-MF ), 00840331269666 (VESTT18-U8VEST-LF ), 00840331269673 (VESTT18-U8VEST-LM ), 00840331269666 (VESTT18-U8VEST-MF ), 00840331269673 (VESTT18-U8VEST-MM ), 00840331269666 (VESTT18-U8VEST-PLUS ), 00840331269666 (VESTT18-U8VEST-SF ), 00840331269673 (VESTT18-U8VEST-SM ), 00840331269666 (VESTT18-U8VEST-XLF ), 00840331269673 (VESTT18-U8VEST-XLM ), 00840331269673 (VESTT18-U8VEST-XSM ), 00840331269666 (VESTT28-U8VEST-2XF ), 00840331269673 (VESTT28-U8VEST-2XM ), 00840331269666 (VESTT28-U8VEST-3XF ), 00840331269673 (VESTT28-U8VEST-3XM ), 00840331269666 (VESTT28-U8VEST-4XF ), 00840331269673 (VESTT28-U8VEST-4XM ), 00840331269666 (VESTT28-U8VEST-5XF ), 00840331269673 (VESTT28-U8VEST-5XM ), 00840331269666 (VESTT38-U8VEST-6XF ), 00840331269673 (VESTT38-U8VEST-6XM ), 00840331269666 (VESTT38-U8VEST-7XF ), 00840331269666 (VESTT38-U8VEST-7XM ), 00840331269666 (VESTT38-U8VEST-8XF ), 00840331269673 (VESTT38-U8VEST-8XM ), None (IVESTC8-U8VEST-2XMR ), None (IVESTC8-U8VEST-LMR ), None (IVESTC8-U8VEST-MMR ), None (IVESTC8-U8VEST-SFR ), None (IVESTC8-U8VEST-SMR ), None (IVESTC8-U8VEST-XLMR ), None (IVESTC8-U8VEST-XSFR ). 17. Model Number: U8ZVEST; UDI-DI (Product Code): 00840331269536 (ZVESTC18-U8ZVEST-MF ), 00840331269543 (ZVESTC18-U8ZVEST-MM ), 00840331269901 (ZVESTT28-U8ZVEST-5XM ).

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.

device · product 3 of 13

Burlington Medical, Kilt

Z-1755-2026

Recall number: Z-1755-2026
Initiated: February 11, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Burlington Medical, LLC
Quantity: 15,216 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for attenuation degradation over time, decreasing the lifespan.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for attenuation degradation over time, decreasing the lifespan.

Code information

All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: C8K303; UDI-DI (Product Code): 00840331297638 (FKILTC18-C8K303-2XM, FKILTC8-C8K303-LF, FKILTC8-C8K303-LM, FKILTC8-C8K303-MF, FKILTC8-C8K303-MM, FKILTC8-C8K303-PLUS, FKILTC8-C8K303-SF, FKILTC8-C8K303-SM, FKILTC8-C8K303-XLF, FKILTC8-C8K303-XLM, FKILTC8-C8K303-XSF, FKILTT18-C8K303-LM, FKILTT18-C8K303-MM, FKILTT18-C8K303-PLUS, FKILTT18-C8K303-SM, FKILTT18-C8K303-XLM, FKILTT18-C8K303-XSM, FKILTT28-C8K303-2XM, FKILTT28-C8K303-4XM, FKILTT28-C8K303-5XM). 2. Model Number: R8K303; UDI-DI (Product Code): 00197513003618 (FKILTC18-R8K303-2XF ), 00197513003618 (FKILTC18-R8K303-3XF ), 00197513002932 (FKILTC8-R8K303-LF ), 00197513002925 (FKILTC8-R8K303-LM ), 00197513002918 (FKILTC8-R8K303-MF ), 00197513002901 (FKILTC8-R8K303-MM ), 00197513002888 (FKILTC8-R8K303-SF ), 00197513002871 (FKILTC8-R8K303-SM ), 00197513002864 (FKILTC8-R8K303-XLF ), 00197513000068 (FKILTT18-R8K303-LF ), 00197513000198 (FKILTT18-R8K303-LM ), 00197513000068 (FKILTT18-R8K303-MF ), 00197513000198 (FKILTT18-R8K303-MM ), 00197513000068 (FKILTT18-R8K303-PLUS ), 00197513000068 (FKILTT18-R8K303-SF ), 00197513000198 (FKILTT18-R8K303-SM ), 00197513000068 (FKILTT18-R8K303-XLF ), 00197513000198 (FKILTT18-R8K303-XLM ), 00197513000198 (FKILTT18-R8K303-XSM ), 00197513000068 (FKILTT28-R8K303-2XF ), 00197513000068 (FKILTT28-R8K303-3XF ), 00197513000198 (FKILTT28-R8K303-3XM ), 00197513000068 (FKILTT28-R8K303-4XF ), 00197513000068 (FKILTT38-R8K303-6XF ). 3. Model Number: R8KILT; UDI-DI (Product Code): None (IKILTC8-R8KILT-LMR ), None (IKILTC8-R8KILT-SMR ), 00840331259681 (KILTC18-R8KILT-2XF ), 00840331259698 (KILTC18-R8KILT-2XM ), 00840331259704 (KILTC18-R8KILT-3XF ), 00840331259711 (KILTC18-R8KILT-3XM ), 00840331259728 (KILTC8-R8KILT-LF ), 00840331259735 (KILTC8-R8KILT-LM ), 00840331259735 (KILTC8-R8KILT-MF ), 00840331259759 (KILTC8-R8KILT-MM ), 00840331259766 (KILTC8-R8KILT-PLUS ), 00840331259773 (KILTC8-R8KILT-SF ), 00840331259780 (KILTC8-R8KILT-SM ), 00840331259797 (KILTC8-R8KILT-XLF ), 00840331259803 (KILTC8-R8KILT-XLM ), 00840331259810 (KILTC8-R8KILT-XSF ), 00840331259827 (KILTC8-R8KILT-XSM ), 00840331259728 (KILTS8-R8KILT-LF ), 00840331259735 (KILTS8-R8KILT-LM ), 00840331259742 (KILTS8-R8KILT-MF ), 00840331259759 (KILTS8-R8KILT-MM ), 00840331259766 (KILTS8-R8KILT-PLUS ), 00840331259773 (KILTS8-R8KILT-SF ), 00840331259780 (KILTS8-R8KILT-SM ), 00840331259797 (KILTS8-R8KILT-XLF ), 00840331259803 (KILTS8-R8KILT-XLM ), 00840331269925 (KILTT18-R8KILT-LF ), 00840331269932 (KILTT18-R8KILT-LM ), 00840331269925 (KILTT18-R8KILT-MF ), 00840331269932 (KILTT18-R8KILT-MM ), 00840331269925 (KILTT18-R8KILT-PLUS ), 00840331269925 (KILTT18-R8KILT-SF ), 00840331269932 (KILTT18-R8KILT-SM ), 00840331269925 (KILTT18-R8KILT-XLF ), 00840331269932 (KILTT18-R8KILT-XLM ), 00840331269925 (KILTT18-R8KILT-XSF ), 00840331269932 (KILTT18-R8KILT-XSM ), 00840331269925 (KILTT28-R8KILT-2XF ), 00840331269932 (KILTT28-R8KILT-2XM ), 00840331269925 (KILTT28-R8KILT-3XF ), 00840331269932 (KILTT28-R8KILT-3XM ), 00840331269925 (KILTT28-R8KILT-4XF ), 00840331269932 (KILTT28-R8KILT-4XM ), 00840331269925 (KILTT28-R8KILT-5XF ), 00840331269932 (KILTT28-R8KILT-5XM ), 00840331269925 (KILTT38-R8KILT-6XF ), 00840331269932 (KILTT38-R8KILT-6XM ), 00840331269925 (KILTT38-R8KILT-7XF ), 00840331269932 (KILTT38-R8KILT-7XM ), 00840331269925 (KILTT38-R8KILT-8XF ), 00840331269932 (KILTT38-R8KILT-8XM ), None (IKILTC8-R8KILT-LFL ), None (IKILTC8-R8KILT-LFR ), None (IKILTC8-R8KILT-MFL ), None (IKILTC8-R8KILT-MFR ), None (IKILTC8-R8KILT-MFXL ), None (IKILTC8-R8KILT-MML ), None (IKILTC8-R8KILT-MMR ), None (IKILTC8-R8KILT-SFL ), None (IKILTC8-R8KILT-SML ), None (IKILTC8-R8KILT-XSFR ), None (IKILTC8-R8KILT-2XFL ), None (IKILTC8-R8KILT-2XFR ), None (IKILTC8-R8KILT-3XFR ), None (IKILTC8-R8KILT-LFS ), None (IKILTC8-R8KILT-LML ), None (IKILTC8-R8KILT-LMXL ), None (IKILTC8-R8KILT-MFS ), None (IKILTC8-R8KILT-SFS ), None (IKILTC8-R8KILT-XLMR ), None (IKILTC8-R8KILT-2XMXL ), None (IKILTC8-R8KILT-PLUSL ), None (IKILTC8-R8KILT-SFR ), None (IKILTC8-R8KILT-XLML ), None (IKILTC8-R8KILT-XSFS ), None (IKILTC8-R8KILT-MMXL ), None (IKILTC8-R8KILT-XLMXL ), None (IKILTC8-R8KILT-2XMR ), None (IKILTC8-R8KILT-XSML ), None (IKILTC8-R8KILT-XSMR ), None (IKILTC8-R8KILT-XSMXL ), None (IFKILTC8-R8K303-LFR), None (IFKILTC8-R8K303-MMR). 4. Model Number: R8S302; UDI-DI (Product Code): 00197513004950 (SKIRTWBC8-R8S302-LF ), 00197513004943 (SKIRTWBC8-R8S302-LM ), 00197513004936 (SKIRTWBC8-R8S302-MF ), 00197513004929 (SKIRTWBC8-R8S302-MM ), 00197513004912 (SKIRTWBC8-R8S302-PLUS ), 00197513004905 (SKIRTWBC8-R8S302-SF ), 00197513004899 (SKIRTWBC8-R8S302-SM ), 00197513004875 (SKIRTWBC8-R8S302-XLM ), 00197513000327 (SKIRTWBT18-R8S302-LF ), 00197513000457 (SKIRTWBT18-R8S302-LM ), 00197513000327 (SKIRTWBT18-R8S302-MF ), 00197513000457 (SKIRTWBT18-R8S302-MM ), 00197513000327 (SKIRTWBT18-R8S302-PLUS ), 00197513000457 (SKIRTWBT18-R8S302-SM ), 00197513000327 (SKIRTWBT18-R8S302-XLF ), 00197513000457 (SKIRTWBT18-R8S302-XLM ), 00197513000457 (SKIRTWBT28-R8S302-2XM ), 00197513000327 (SKIRTWBT28-R8S302-3XF ), 00197513000457 (SKIRTWBT28-R8S302-3XM ), 00197513000457 (SKIRTWBT28-R8S302-4XM ), 00197513000327 (SKIRTWBT28-R8S302-5XF ), 00197513000457 (SKIRTWBT28-R8S302-5XM ), 00197513000327 (SKIRTWBT38-R8S302-6XF ), 00197513000457 (SKIRTWBT38-R8S302-6XM ), 00197513000327 (SKIRTWBT38-R8S302-8XF ), 00197513000457 (SKIRTWBT38-R8S302-8XM ), None (ISKIRTWBC8-R8S302-MFL ), None (ISKIRTWBC8-R8S302-MFR ), None (ISKIRTWBC8-R8S302-MML ), None (ISKIRTWBC8-R8S302-MMR ), None (ISKIRTWBC8-R8S302-MMXL ), None (ISKIRTWBC8-R8S302-PLUSL ), None (ISKIRTWBC8-R8S302-SFL ), None (ISKIRTWBC8-R8S302-SML ). 5. Model Number: R8SKIRT; UDI-DI (Product Code): 00840331260182 (SKIRTC8-R8SKIRT-LM ), 00840331260205 (SKIRTC8-R8SKIRT-MM ), 00840331260250 (SKIRTC8-R8SKIRT-XLM ), 00840331269987 (SKIRTT18-R8SKIRT-LF ), 00840331269994 (SKIRTT18-R8SKIRT-LM ), 00840331269987 (SKIRTT18-R8SKIRT-MF ), 00840331269994 (SKIRTT18-R8SKIRT-MM ), 00840331269987 (SKIRTT18-R8SKIRT-PLUS ), 00840331269994 (SKIRTT18-R8SKIRT-SM ), 00840331269987 (SKIRTT18-R8SKIRT-XLF ), 00840331269994 (SKIRTT18-R8SKIRT-XLM ), 00840331269994 (SKIRTT18-R8SKIRT-XSM ), 00840331269987 (SKIRTT28-R8SKIRT-2XF ), 00840331269994 (SKIRTT28-R8SKIRT-2XM ), 00840331269994 (SKIRTT28-R8SKIRT-3XM ), 00840331269994 (SKIRTT28-R8SKIRT-4XM ), 00840331270013 (SKIRTT38-R8SKIRT-6XM ). 6. Model Number: S8K303; UDI-DI (Product Code): 00197513002802 (FKILTC8-S8K303-LM ), 00197513002796 (FKILTC8-S8K303-MF ), 00197513002789 (FKILTC8-S8K303-MM ), 00197513002734 (FKILTC8-S8K303-XLM ), 00197513002727 (FKILTC8-S8K303-XSF ), 00197513000051 (FKILTT18-S8K303-MF ), 00197513000181 (FKILTT18-S8K303-MM ), 00197513000051 (FKILTT18-S8K303-PLUS ), 00197513000181 (FKILTT18-S8K303-SM ), 00197513000181 (FKILTT18-S8K303-XSM ), 00197513000181 (FKILTT28-S8K303-2XM ), 00197513000051 (FKILTT28-S8K303-3XF ), 00197513000181 (FKILTT28-S8K303-3XM ), 00197513000181 (FKILTT28-S8K303-4XM ). 7. Model Number: S8KILT; UDI-DI (Product Code): 00840331263435 (KILTC18-S8KILT-2XF ), 00840331263442 (KILTC18-S8KILT-2XM ), 00840331263459 (KILTC18-S8KILT-3XF ), 00840331263466 (KILTC18-S8KILT-3XM ), 00840331263473 (KILTC8-S8KILT-LF ), 00840331263480 (KILTC8-S8KILT-LM ), 00840331263497 (KILTC8-S8KILT-MF ), 00840331263503 (KILTC8-S8KILT-MM ), 00840331263510 (KILTC8-S8KILT-PLUS ), 00840331263527 (KILTC8-S8KILT-SF ), 00840331263534 (KILTC8-S8KILT-SM ), 00840331263541 (KILTC8-S8KILT-XLF ), 00840331263558 (KILTC8-S8KILT-XLM ), 00840331263565 (KILTC8-S8KILT-XSF ), 00840331263565 (KILTC8-S8KILT-XSM ), 00840331263473 (KILTS8-S8KILT-LF ), 00840331263480 (KILTS8-S8KILT-LM ), 00840331263497 (KILTS8-S8KILT-MF ), 00840331263503 (KILTS8-S8KILT-MM ), 00840331263527 (KILTS8-S8KILT-SF ), 00840331263534 (KILTS8-S8KILT-SM ), 00840331263541 (KILTS8-S8KILT-XLF ), 00840331263558 (KILTS8-S8KILT-XLM ), 00840331269949 (KILTT18-S8KILT-LF ), 00840331269956 (KILTT18-S8KILT-LM ), 00840331269949 (KILTT18-S8KILT-MF ), 00840331269956 (KILTT18-S8KILT-MM ), 00840331269949 (KILTT18-S8KILT-PLUS ), 00840331269949 (KILTT18-S8KILT-SF ), 00840331269956 (KILTT18-S8KILT-SM ), 00840331269949 (KILTT18-S8KILT-XLF ), 00840331269956 (KILTT18-S8KILT-XLM ), 00840331269949 (KILTT18-S8KILT-XSF ), 00840331269956 (KILTT18-S8KILT-XSM ), 00840331269949 (KILTT28-S8KILT-2XF ), 00840331269956 (KILTT28-S8KILT-2XM ), 00840331269949 (KILTT28-S8KILT-3XF ), 00840331269956 (KILTT28-S8KILT-3XM ), 00840331269949 (KILTT28-S8KILT-4XF ), 00840331269956 (KILTT28-S8KILT-4XM ), 00840331269949 (KILTT28-S8KILT-5XF ), 00840331269956 (KILTT28-S8KILT-5XM ), 00840331269949 (KILTT38-S8KILT-6XF ), 00840331269956 (KILTT38-S8KILT-6XM ), 00840331269949 (KILTT38-S8KILT-7XF ), 00840331269956 (KILTT38-S8KILT-7XM ), 00840331269949 (KILTT38-S8KILT-8XF ), 00840331269956 (KILTT38-S8KILT-8XM ), None (IKILTC8-S8KILT-LMR ), None (IKILTC8-S8KILT-MMR ). 8. Model Number: S8S302; UDI-DI (Product Code): 00197513004837 (SKIRTWBC8-S8S302-LF ), 00197513004820 (SKIRTWBC8-S8S302-LM ), 00197513004813 (SKIRTWBC8-S8S302-MF), 00197513004806 (SKIRTWBC8-S8S302-MM ), 00197513004790 (SKIRTWBC8-S8S302-PLUS), 00197513000310 (SKIRTWBT18-S8S302-LF ), 00197513000440 (SKIRTWBT18-S8S302-LM), 00197513000310 (SKIRTWBT18-S8S302-MF ), 00197513000440 (SKIRTWBT18-S8S302-MM), 00197513000310 (SKIRTWBT18-S8S302-PLUS ), 00197513000440 (SKIRTWBT18-S8S302-SM ), 00197513000310 (SKIRTWBT18-S8S302-XLF ), 00197513000440 (SKIRTWBT18-S8S302-XLM ), 00197513000440 (SKIRTWBT18-S8S302-XSM ), 00197513000310 (SKIRTWBT28-S8S302-3XF ), 00197513000440 (SKIRTWBT28-S8S302-3XM), 00197513000440 (SKIRTWBT28-S8S302-4XM ), 00197513000440 (SKIRTWBT28-S8S302-5XM ). 9. Model Number: S8SKIRT; UDI-DI (Product Code): 00840331270006 (SKIRTT18-S8SKIRT-LF ), 00840331270013 (SKIRTT18-S8SKIRT-LM ), 00840331270006 (SKIRTT18-S8SKIRT-MF ), 00840331270006 (SKIRTT18-S8SKIRT-PLUS ), 00840331270013 (SKIRTT18-S8SKIRT-SM ), 00840331270006 (SKIRTT18-S8SKIRT-XLF ), 00840331270006 (SKIRTT28-S8SKIRT-3XF ), 00840331270013 (SKIRTT28-S8SKIRT-4XM ). 10. Model Number: U8K303; UDI-DI (Product Code): 00197513002680 (FKILTC8-U8K303-LM), 00197513002673 (FKILTC8-U8K303-MF ), 00197513002666 (FKILTC8-U8K303-MM ), 00197513002642 (FKILTC8-U8K303-SF ), 00197513002635 (FKILTC8-U8K303-SM ), 00197513000174 (FKILTT18-U8K303-LM ), 00197513000044 (FKILTT18-U8K303-MF ), 00197513000174 (FKILTT18-U8K303-MM ), 00197513000044 (FKILTT18-U8K303-PLUS ), 00197513000174 (FKILTT18-U8K303-SM ), 00197513000174 (FKILTT28-U8K303-2XM ), 00197513000044 (FKILTT28-U8K303-4XF ), 00197513000174 (FKILTT28-U8K303-4XM ), 00197513000044 (FKILTT28-U8K303-5XF ), 00197513000174 (FKILTT28-U8K303-5XM ), None (IFKILTC8-U8K303-2XMR ), None (IFKILTC8-U8K303-LMR ), None (IFKILTC8-U8K303-MMR ), None (IFKILTC8-U8K303-SFR ), None (IFKILTC8-U8K303-SMR ), None (IFKILTC8-U8K303-XLMR ). 11. Model Number: U8KILT; UDI-DI (Product Code): 00840331267167 (KILTC18-U8KILT-2XF ), 00840331267174 (KILTC18-U8KILT-2XM ), 00840331267181 (KILTC18-U8KILT-3XF ), 00840331267204 (KILTC8-U8KILT-LF ), 00840331267211 (KILTC8-U8KILT-LM ), 00840331267228 (KILTC8-U8KILT-MF ), 00840331267235 (KILTC8-U8KILT-MM ), 00840331267242 (KILTC8-U8KILT-PLUS ), 00840331267259 (KILTC8-U8KILT-SF ), 00840331267266 (KILTC8-U8KILT-SM ), 00840331267273 (KILTC8-U8KILT-XLF ), 00840331267280 (KILTC8-U8KILT-XLM ), 00840331267297 (KILTC8-U8KILT-XSF ), 00840331267303 (KILTC8-U8KILT-XSM ), 00840331267204 (KILTS8-U8KILT-LF ), 00840331267211 (KILTS8-U8KILT-LM ), 00840331267228 (KILTS8-U8KILT-MF ), 00840331269963 (KILTT18-U8KILT-LF ), 00840331269970 (KILTT18-U8KILT-LM ), 00840331269963 (KILTT18-U8KILT-MF ), 00840331269970 (KILTT18-U8KILT-MM ), 00840331269963 (KILTT18-U8KILT-PLUS ), 00840331269963 (KILTT18-U8KILT-SF ), 00840331269970 (KILTT18-U8KILT-SM ), 00840331269963 (KILTT18-U8KILT-XLF ), 00840331269970 (KILTT18-U8KILT-XLM ), 00840331269970 (KILTT18-U8KILT-XSM ), 00840331269963 (KILTT28-U8KILT-2XF ), 00840331269970 (KILTT28-U8KILT-2XM ), 00840331269963 (KILTT28-U8KILT-3XF ), 00840331269970 (KILTT28-U8KILT-3XM ), 00840331269963 (KILTT28-U8KILT-4XF ), 00840331269970 (KILTT28-U8KILT-4XM ), 00840331269963 (KILTT28-U8KILT-5XF ), 00840331269970 (KILTT28-U8KILT-5XM ), 00840331269963 (KILTT38-U8KILT-6XF ), 00840331269970 (KILTT38-U8KILT-6XM ), 00840331269963 (KILTT38-U8KILT-7XF ), 00840331269970 (KILTT38-U8KILT-7XM ), 00840331269963 (KILTT38-U8KILT-8XF ), 00840331269970 (KILTT38-U8KILT-8XM ), None (IKILTC8-U8KILT-2XMR ), None (IKILTC8-U8KILT-LFR ), None (IKILTC8-U8KILT-LMR ), None (IKILTC8-U8KILT-LMXL ), None (IKILTC8-U8KILT-MFR ), None (IKILTC8-U8KILT-MMR ), None (IKILTC8-U8KILT-SFR ), None (IKILTC8-U8KILT-SMR ), None (IKILTC8-U8KILT-XLMR ), None (IKILTC8-U8KILT-XLMXL ), None (IKILTC8-U8KILT-XSFR ). 12. Model Number: U8S302; UDI-DI (Product Code): 00197513004714 (SKIRTWBC8-U8S302-LF ), 00197513004691 (SKIRTWBC8-U8S302-MF ), 00197513004684 (SKIRTWBC8-U8S302-MM ), 00197513004677 (SKIRTWBC8-U8S302-PLUS ), 00197513004660 (SKIRTWBC8-U8S302-SF ), 00197513004622 (SKIRTWBC8-U8S302-XSF ), 00197513000303 (SKIRTWBT18-U8S302-PLUS ).

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.

device · product 4 of 13

Burlington Medical, Frontal Aprons

Z-1756-2026

Recall number: Z-1756-2026
Initiated: February 11, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Burlington Medical, LLC
Quantity: 14323

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for attenuation degradation over time, decreasing the lifespan.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for attenuation degradation over time, decreasing the lifespan.

Code information

All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: C8F17; UDI-DI (Product Code): 00840331297706 (FRONTALC18-C8F17-2XM ), 00840331297706 (FRONTALC8-C8F17-LF ), 00840331297706 (FRONTALC8-C8F17-LM ), 00840331297706 (FRONTALC8-C8F17-MF ), 00840331297706 (FRONTALC8-C8F17-MM ), 00840331297706 (FRONTALC8-C8F17-SF ), 00840331297706 (FRONTALC8-C8F17-SM ), 00840331297706 (FRONTALC8-C8F17-XLM ), 00840331297706 (FRONTALC8-C8F17-XSF ), 00840331297706 (FRONTALT18-C8F17-LM ), 00840331297706 (FRONTALT18-C8F17-MM ), 00840331297706 (FRONTALT28-C8F17-3XM ). 2. Model Number: R8601; UDI-DI (Product Code): 00840331258400 (FRONTALC18-R8601-2XF ), 00840331258417 (FRONTALC18-R8601-2XM ), 00840331258448 (FRONTALC8-R8601-LF ), 00840331258455 (FRONTALC8-R8601-LM ), 00840331258462 (FRONTALC8-R8601-MF ), 00840331258479 (FRONTALC8-R8601-MM ), 00840331258486 (FRONTALC8-R8601-PLUS ), 00840331258493 (FRONTALC8-R8601-SF ), 00840331258509 (FRONTALC8-R8601-SM ), 00840331258516 (FRONTALC8-R8601-XLF ), 00840331258523 (FRONTALC8-R8601-XLM ), 00840331270341 (FRONTALT18-R8601-LF ), 00840331270358 (FRONTALT18-R8601-LM ), 00840331270341 (FRONTALT18-R8601-MF ), 00840331270358 (FRONTALT18-R8601-MM ), 00840331270341 (FRONTALT18-R8601-PLUS ), 00840331270341 (FRONTALT18-R8601-SF ), 00840331270358 (FRONTALT18-R8601-SM ), 00840331270358 (FRONTALT18-R8601-XLM ), 00840331270341 (FRONTALT28-R8601-2XF ), 00840331270358 (FRONTALT28-R8601-2XM ), 00840331270358 (FRONTALT28-R8601-3XM ), 00840331270358 (FRONTALT28-R8601-4XM ), None (IFRONTALC8-R8601-2XMR ), None (IFRONTALC8-R8601-LMR ), None (IFRONTALC8-R8601-MFR ), None (IFRONTALC8-R8601-MMR ), None (IFRONTALC8-R8601-SFR ), None (IFRONTALC8-R8601-SMR ), None (IFRONTALC8-R8601-XLMR ), None (IFRONTALC8-R8601-XSFR ), None (IFRONTALC8-R8601-XSMR ), None (IFRONTALC8-R8601-LML ). 3. Model Number: R8A10; UDI-DI (Product Code): 00840331258578 (FRONTALC18-R8A10-2XM ), 00840331258608 (FRONTALC8-R8A10-LF ), 00840331258615 (FRONTALC8-R8A10-LM ), 00840331258622 (FRONTALC8-R8A10-MF ), 00840331258639 (FRONTALC8-R8A10-MM ), 00840331258646 (FRONTALC8-R8A10-PLUS ), 00840331258653 (FRONTALC8-R8A10-SF ), 00840331258660 (FRONTALC8-R8A10-SM ), 00840331258677 (FRONTALC8-R8A10-XLF ), 00840331258684 (FRONTALC8-R8A10-XLM ), 00840331258691 (FRONTALC8-R8A10-XSF ), 00840331258707 (FRONTALC8-R8A10-XSM ), 00840331270280 (FRONTALT18-R8A10-LF ), 00840331270297 (FRONTALT18-R8A10-LM ), 00840331270280 (FRONTALT18-R8A10-MF ), 00840331270297 (FRONTALT18-R8A10-MM ), 00840331270280 (FRONTALT18-R8A10-PLUS ), 00840331270280 (FRONTALT18-R8A10-SF ), 00840331270297 (FRONTALT18-R8A10-SM ), 00840331270297 (FRONTALT18-R8A10-XLM ), 00840331270297 (FRONTALT28-R8A10-2XM ), 00840331270297 (FRONTALT28-R8A10-3XM ), 00840331270297 (FRONTALT28-R8A10-4XM ), 00840331270297 (FRONTALT28-R8A10-5XM ), None (IFRONTALC8-R8A10-LMR ), None (IFRONTALC8-R8A10-MFR ), None (IFRONTALC8-R8A10-MMR ), None (IFRONTALC8-R8A10-XLMR ). 4. Model Number: R8F01; UDI-DI (Product Code): 00840331258899 (FRONTALC18-R8F01-2XM ), 00840331258929 (FRONTALC8-R8F01-LF ), 00840331258936 (FRONTALC8-R8F01-LM ), 00840331258943 (FRONTALC8-R8F01-MF ), 00840331258950 (FRONTALC8-R8F01-MM ), 00840331258936 (FRONTALS8-R8F01-LM ), 00840331258943 (FRONTALS8-R8F01-MF ), 00840331259001 (FRONTALS8-R8F01-XLM ). 5. Model Number: R8F17; UDI-DI (Product Code): 00840331259360 (FRONTALC18-R8F17-2XF ), 00840331259377 (FRONTALC18-R8F17-2XM ), 00840331259384 (FRONTALC18-R8F17-3XF ), 00840331259391 (FRONTALC18-R8F17-3XM ), 00840331259407 (FRONTALC8-R8F17-LF ), 00840331259414 (FRONTALC8-R8F17-LM ), 00840331259421 (FRONTALC8-R8F17-MF ), 00840331259438 (FRONTALC8-R8F17-MM ), 00840331259445 (FRONTALC8-R8F17-PLUS ), 00840331259452 (FRONTALC8-R8F17-SF ), 00840331259469 (FRONTALC8-R8F17-SM ), 00840331259476 (FRONTALC8-R8F17-XLF ), 00840331259483 (FRONTALC8-R8F17-XLM ), 00840331259490 (FRONTALC8-R8F17-XSF ), 00840331259506 (FRONTALC8-R8F17-XSM ), 00840331259407 (FRONTALS8-R8F17-LF ), 00840331259414 (FRONTALS8-R8F17-LM ), 00840331259414 (FRONTALS8-R8F17-MF ), 00840331259438 (FRONTALS8-R8F17-MM ), 00840331259452 (FRONTALS8-R8F17-SF ), 00840331259469 (FRONTALS8-R8F17-SM ), 00840331259476 (FRONTALS8-R8F17-XLF ), 00840331259483 (FRONTALS8-R8F17-XLM ), 00840331259506 (FRONTALS8-R8F17-XSM ), 00840331270228 (FRONTALT18-R8F17-LF ), 00840331270235 (FRONTALT18-R8F17-LM ), 00840331270228 (FRONTALT18-R8F17-MF ), 00840331270235 (FRONTALT18-R8F17-MM ), 00840331270228 (FRONTALT18-R8F17-PLUS ), 00840331270228 (FRONTALT18-R8F17-SF ), 00840331270235 (FRONTALT18-R8F17-SM ), 00840331270228 (FRONTALT18-R8F17-XLF ), 00840331270235 (FRONTALT18-R8F17-XLM ), 00840331270228 (FRONTALT18-R8F17-XSF ), 00840331270235 (FRONTALT18-R8F17-XSM ), 00840331270228 (FRONTALT28-R8F17-2XF ), 00840331270235 (FRONTALT28-R8F17-2XM ), 00840331270228 (FRONTALT28-R8F17-3XF ), 00840331270235 (FRONTALT28-R8F17-3XM ), 00840331270228 (FRONTALT28-R8F17-4XF ), 00840331270235 (FRONTALT28-R8F17-4XM ), 00840331270228 (FRONTALT28-R8F17-5XF ), None (IFRONTALC8-R8F17-LML ), None (IFRONTALC8-R8F17-MMR ), None (IFRONTALC8-R8F17-XLMXL ), None (IFRONTALC8-R8F17-MFR ), None (IFRONTALC8-R8F17-MML ), None (IFRONTALC8-R8F17-SMR ), None (IFRONTALC8-R8F17-PLUSL ), None (IFRONTALC8-R8F17-SFR ), None (IFRONTALC8-R8F17-LFR ), None (IFRONTALC8-R8F17-MFS ), None (IFRONTALC8-R8F17-SML ), None (IFRONTALC8-R8F17-LMR ). 6. Model Number: R8P500; UDI-DI (Product Code): 00197513001287 (PFRONTALC8-R8P500-LG ), 00197513001270 (PFRONTALC8-R8P500-MD ). 7. Model Number: S8601; UDI-DI (Product Code): 00840331262179 (FRONTALC18-S8601-2XM ), 00840331262209 (FRONTALC8-S8601-LF ), 00840331296174 (FRONTALC8-S8601-LM ), 00840331262216 (FRONTALC8-S8601-MF ), 00840331262223 (FRONTALC8-S8601-MM ), 00840331262230 (FRONTALC8-S8601-PLUS ), 00840331262247 (FRONTALC8-S8601-SF ), 00840331262254 (FRONTALC8-S8601-SM ), 00840331262261 (FRONTALC8-S8601-XLF ), 00840331262278 (FRONTALC8-S8601-XLM ), 00840331262285 (FRONTALC8-S8601-XSF ), 00840331270365 (FRONTALT18-S8601-LF ), 00840331270372 (FRONTALT18-S8601-LM ), 00840331270365 (FRONTALT18-S8601-MF ), 00840331270372 (FRONTALT18-S8601-MM ), 00840331270365 (FRONTALT18-S8601-PLUS ), 00840331270372 (FRONTALT18-S8601-SM ), 00840331270372 (FRONTALT18-S8601-XLF ), 00840331270372 (FRONTALT18-S8601-XLM ), 00840331270372 (FRONTALT28-S8601-2XM ), 00840331270372 (FRONTALT28-S8601-3XM ), 00840331270372 (FRONTALT28-S8601-4XM ), None (IFRONTALC8-S8601-PLUSL ). 8. Model Number: S8A10; UDI-DI (Product Code): 00840331262315 (FRONTALC18-S8A10-2XF ), 00840331262322 (FRONTALC18-S8A10-2XM ), 00840331262339 (FRONTALC18-S8A10-3XF ), 00840331262353 (FRONTALC8-S8A10-LF ), 00840331262360 (FRONTALC8-S8A10-LM ), 00840331262377 (FRONTALC8-S8A10-MF ), 00840331262384 (FRONTALC8-S8A10-MM ), 00840331262391 (FRONTALC8-S8A10-PLUS ), 00840331262407 (FRONTALC8-S8A10-SF ), 00840331262414 (FRONTALC8-S8A10-SM ), 00840331262421 (FRONTALC8-S8A10-XLF ), 00840331262438 (FRONTALC8-S8A10-XLM ), 00840331262445 (FRONTALC8-S8A10-XSF ), 00840331270303 (FRONTALT18-S8A10-LF ), 00840331270310 (FRONTALT18-S8A10-LM ), 00840331270303 (FRONTALT18-S8A10-MF ), 00840331270310 (FRONTALT18-S8A10-MM ), 00840331270303 (FRONTALT18-S8A10-PLUS ), 00840331270303 (FRONTALT18-S8A10-SF ), 00840331270310 (FRONTALT18-S8A10-SM ), 00840331270303 (FRONTALT18-S8A10-XLF ), 00840331270310 (FRONTALT18-S8A10-XLM ), 00840331270310 (FRONTALT28-S8A10-2XM ), 00840331270303 (FRONTALT28-S8A10-3XF ), 00840331270310 (FRONTALT28-S8A10-4XM ), 00840331270303 (FRONTALT28-S8A10-5XF ). 9. Model Number: S8F01; UDI-DI (Product Code): 00840331262674 (FRONTALC8-S8F01-LF ), 00840331262698 (FRONTALC8-S8F01-MF ), 00840331262704 (FRONTALC8-S8F01-MM ), 00840331262728 (FRONTALC8-S8F01-SF ), 00840331262742 (FRONTALC8-S8F01-XLF ), 00840331262759 (FRONTALC8-S8F01-XLM ), 00840331262766 (FRONTALC8-S8F01-XSF ), 00840331270433 (FRONTALT18-S8F01-MM ), 00840331270426 (FRONTALT18-S8F01-PLUS ). 10. Model Number: S8F17; UDI-DI (Product Code): 00840331263114 (FRONTALC18-S8F17-2XF ), 00840331263121 (FRONTALC18-S8F17-2XM ), 00840331263138 (FRONTALC18-S8F17-3XF ), 00840331263145 (FRONTALC18-S8F17-3XM ), 00840331263152 (FRONTALC8-S8F17-LF ), 00840331263169 (FRONTALC8-S8F17-LM ), 00840331263176 (FRONTALC8-S8F17-MF ), 00840331263183 (FRONTALC8-S8F17-MM ), 00840331263190 (FRONTALC8-S8F17-PLUS ), 00840331263206 (FRONTALC8-S8F17-SF ), 00840331263213 (FRONTALC8-S8F17-SM ), 00840331263220 (FRONTALC8-S8F17-XLF ), 00840331263237 (FRONTALC8-S8F17-XLM ), 00840331263244 (FRONTALC8-S8F17-XSF ), 00840331263251 (FRONTALC8-S8F17-XSM ), 00840331263152 (FRONTALS8-S8F17-LF ), 00840331263169 (FRONTALS8-S8F17-LM ), 00840331263176 (FRONTALS8-S8F17-MF ), 00840331263183 (FRONTALS8-S8F17-MM ), 00840331263190 (FRONTALS8-S8F17-PLUS ), 00840331263206 (FRONTALS8-S8F17-SF ), 00840331263213 (FRONTALS8-S8F17-SM ), 00840331263220 (FRONTALS8-S8F17-XLF ), 00840331263237 (FRONTALS8-S8F17-XLM ), 00840331263244 (FRONTALS8-S8F17-XSF ), 00840331263251 (FRONTALS8-S8F17-XSM ), 00840331270242 (FRONTALT18-S8F17-LF ), 00840331270259 (FRONTALT18-S8F17-LM ), 00840331270242 (FRONTALT18-S8F17-MF ), 00840331270259 (FRONTALT18-S8F17-MM ), 00840331270242 (FRONTALT18-S8F17-PLUS ), 00840331270242 (FRONTALT18-S8F17-SF ), 00840331270259 (FRONTALT18-S8F17-SM ), 00840331270242 (FRONTALT18-S8F17-XLF ), 00840331270259 (FRONTALT18-S8F17-XLM ), 00840331270242 (FRONTALT18-S8F17-XSF ), 00840331270259 (FRONTALT18-S8F17-XSM ), 00840331270242 (FRONTALT28-S8F17-2XF ), 00840331270259 (FRONTALT28-S8F17-2XM ), 00840331270242 (FRONTALT28-S8F17-3XF ), 00840331270259 (FRONTALT28-S8F17-3XM ), 00840331270242 (FRONTALT28-S8F17-4XF ), 00840331270259 (FRONTALT28-S8F17-4XM ), 00840331270242 (FRONTALT28-S8F17-5XF ), 00840331270259 (FRONTALT28-S8F17-5XM ). 11. Model Number: U8601; UDI-DI (Product Code): 00840331265927 (FRONTALC8-U8601-LF ), 00840331265934 (FRONTALC8-U8601-LM ), 00840331265941 (FRONTALC8-U8601-MF ), 00840331265958 (FRONTALC8-U8601-MM ), 00840331265972 (FRONTALC8-U8601-SF ), 00840331265989 (FRONTALC8-U8601-SM ), 00840331265996 (FRONTALC8-U8601-XLF ), 00840331266009 (FRONTALC8-U8601-XLM ), 00840331266023 (FRONTALC8-U8601-XSM ), 00840331270389 (FRONTALT18-U8601-LF ), 00840331270396 (FRONTALT18-U8601-LM ), 00840331270389 (FRONTALT18-U8601-MF ), 00840331270396 (FRONTALT18-U8601-MM ), 00840331270389 (FRONTALT18-U8601-PLUS ), 00840331270389 (FRONTALT18-U8601-XLF ), 00840331270396 (FRONTALT18-U8601-XLM ), 00840331270396 (FRONTALT28-U8601-2XM ), None (IFRONTALC8-U8601-LML ). 12. Model Number: U8A10; UDI-DI (Product Code): 00840331266054 (FRONTALC18-U8A10-2XM ), 00840331266085 (FRONTALC8-U8A10-LF ), 00840331266092 (FRONTALC8-U8A10-LM ), 00840331266108 (FRONTALC8-U8A10-MF ), 00840331266115 (FRONTALC8-U8A10-MM ), 00840331266122 (FRONTALC8-U8A10-PLUS ), 00840331266139 (FRONTALC8-U8A10-SF ), 00840331266146 (FRONTALC8-U8A10-SM ), 00840331266160 (FRONTALC8-U8A10-XLM ), 00840331270327 (FRONTALT18-U8A10-LF ), 00840331270334 (FRONTALT18-U8A10-LM ), 00840331270334 (FRONTALT18-U8A10-MM ), 00840331270334 (FRONTALT18-U8A10-PLUS ), 00840331270334 (FRONTALT18-U8A10-XLM ), 00840331270327 (FRONTALT28-U8A10-2XF ). 13. Model Number: U8F01; UDI-DI (Product Code): 00840331266450 (FRONTALC8-U8F01-SF ), 14. Model Number: U8F17; UDI-DI (Product Code): 00840331266856 (FRONTALC18-U8F17-2XM ), 00840331266863 (FRONTALC18-U8F17-3XF ), 00840331266870 (FRONTALC18-U8F17-3XM ), 00840331266887 (FRONTALC8-U8F17-LF ), 00840331266894 (FRONTALC8-U8F17-LM ), 00840331266900 (FRONTALC8-U8F17-MF ), 00840331266917 (FRONTALC8-U8F17-MM ), 00840331266924 (FRONTALC8-U8F17-PLUS ), 00840331266931 (FRONTALC8-U8F17-SF ), 00840331266948 (FRONTALC8-U8F17-SM ), 00840331266955 (FRONTALC8-U8F17-XLF ), 00840331266962 (FRONTALC8-U8F17-XLM ), 00840331266979 (FRONTALC8-U8F17-XSF ), 00840331266979 (FRONTALC8-U8F17-XSM ), 00840331266894 (FRONTALS8-U8F17-LM ), 00840331266900 (FRONTALS8-U8F17-MF ), 00840331266917 (FRONTALS8-U8F17-MM ), 00840331266931 (FRONTALS8-U8F17-SF ), 00840331266948 (FRONTALS8-U8F17-SM ), 00840331266962 (FRONTALS8-U8F17-XLM ), 00840331266986 (FRONTALS8-U8F17-XSM ), 00840331270266 (FRONTALT18-U8F17-LF ), 00840331270273 (FRONTALT18-U8F17-LM ), 00840331270266 (FRONTALT18-U8F17-MF ), 00840331270273 (FRONTALT18-U8F17-MM ), 00840331270266 (FRONTALT18-U8F17-PLUS ), 00840331270266 (FRONTALT18-U8F17-SF ), 00840331270273 (FRONTALT18-U8F17-SM ), 00840331270266 (FRONTALT18-U8F17-XLF ), 00840331270273 (FRONTALT18-U8F17-XLM ), 00840331270273 (FRONTALT18-U8F17-XSM ), 00840331270266 (FRONTALT28-U8F17-2XF ), 00840331270273 (FRONTALT28-U8F17-2XM ), 00840331270266 (FRONTALT28-U8F17-3XF ), 00840331270273 (FRONTALT28-U8F17-3XM ), 00840331270266 (FRONTALT28-U8F17-4XF ), 00840331270273 (FRONTALT28-U8F17-4XM ), None (IFRONTALC8-U8F17-2XMR ), None (IFRONTALC8-U8F17-LMR ), None (IFRONTALC8-U8F17-MMR ).

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.

device · product 5 of 13

Burlington Medical, Wrap Aprons.

Z-1757-2026

Recall number: Z-1757-2026
Initiated: February 11, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Burlington Medical, LLC
Quantity: 5,198 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for attenuation degradation over time, decreasing the lifespan.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for attenuation degradation over time, decreasing the lifespan.

Code information

All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: C8EURO; UDI-DI (Product Code): 00840331297683 (WRAPC8-C8EURO-LF ), 00840331297683 (WRAPC8-C8EURO-LM ), 00840331297683 (WRAPC8-C8EURO-MF ), 00840331297683 (WRAPC8-C8EURO-MM ), 00840331297683 (WRAPC8-C8EURO-SF ), 00840331297683 (WRAPC8-C8EURO-SM ), 00840331297683 (WRAPC8-C8EURO-XLM ), 00840331297683 (WRAPT18-C8EURO-LF ), 00840331297683 (WRAPT18-C8EURO-LM ), 00840331297683 (WRAPT18-C8EURO-MM ), 00840331297683 (WRAPT18-C8EURO-PLUS ), 00840331297683 (WRAPT18-C8EURO-SM ). 2. Model Number: C8F111; UDI-DI (Product Code): 00840331297690 (WRAPT18-C8F111-MM). 3. Model Number: R8EURO; UDI-DI (Product Code): 00840331258721 (WRAPC18-R8EURO-2XF ), 00840331258738 (WRAPC18-R8EURO-2XM ), 00840331258745 (WRAPC18-R8EURO-3XF ), 00840331258752 (WRAPC18-R8EURO-3XM ), 00840331258769 (WRAPC8-R8EURO-LF ), 00840331258776 (WRAPC8-R8EURO-LM ), 00840331258783 (WRAPC8-R8EURO-MF ), 00840331258790 (WRAPC8-R8EURO-MM ), 00840331258806 (WRAPC8-R8EURO-PLUS ), 00840331258813 (WRAPC8-R8EURO-SF ), 00840331258820 (WRAPC8-R8EURO-SM ), 00840331258837 (WRAPC8-R8EURO-XLF ), 00840331258844 (WRAPC8-R8EURO-XLM ), 00840331258851 (WRAPC8-R8EURO-XSF ), 00840331258868 (WRAPC8-R8EURO-XSM ), 00840331258769 (WRAPS8-R8EURO-LF ), 00840331258776 (WRAPS8-R8EURO-LM ), 00840331258783 (WRAPS8-R8EURO-MF ), 00840331258790 (WRAPS8-R8EURO-MM ), 00840331258813 (WRAPS8-R8EURO-SF ), 00840331258820 (WRAPS8-R8EURO-SM ), 00840331258837 (WRAPS8-R8EURO-XLF ), 00840331258844 (WRAPS8-R8EURO-XLM ), 00840331270044 (WRAPT18-R8EURO-LF ), 00840331270051 (WRAPT18-R8EURO-LM ), 00840331270051 (WRAPT18-R8EURO-MF ), 00840331270051 (WRAPT18-R8EURO-MM ), 00840331270044 (WRAPT18-R8EURO-PLUS ), 00840331270044 (WRAPT18-R8EURO-SF ), 00840331270051 (WRAPT18-R8EURO-SM ), 00840331270044 (WRAPT18-R8EURO-XLF ), 00840331270051 (WRAPT18-R8EURO-XLM ), 00840331270051 (WRAPT18-R8EURO-XSM ), 00840331270044 (WRAPT28-R8EURO-2XF ), 00840331270051 (WRAPT28-R8EURO-2XM ), 00840331270044 (WRAPT28-R8EURO-3XF ), 00840331270051 (WRAPT28-R8EURO-3XM ), 00840331270044 (WRAPT28-R8EURO-4XF ), 00840331270051 (WRAPT28-R8EURO-4XM ), 00840331270044 (WRAPT28-R8EURO-5XF ), 00840331270051 (WRAPT28-R8EURO-5XM ), 00840331270044 (WRAPT38-R8EURO-6XF ), 00840331270051 (WRAPT38-R8EURO-6XM ), 00840331270044 (WRAPT38-R8EURO-7XF ), 00840331270051 (WRAPT38-R8EURO-7XM ), 00840331270044 (WRAPT38-R8EURO-8XF ), 00840331270051 (WRAPT38-R8EURO-8XM ), None (IWRAPC8-R8EURO-LFR ), None (IWRAPC8-R8EURO-MFR ), None (IWRAPC8-R8EURO-PLUSL ), None (IWRAPC8-R8EURO-SFS ). 4. Model Number: R8F111; UDI-DI (Product Code): 00840331259049 (WRAPC18-R8F111-2XF ), 00840331259056 (WRAPC18-R8F111-2XM ), 00840331259063 (WRAPC18-R8F111-3XF ), 00840331259087 (WRAPC8-R8F111-LF ), 00840331259094 (WRAPC8-R8F111-LM ), 00840331259100 (WRAPC8-R8F111-MF ), 00840331259117 (WRAPC8-R8F111-MM ), 00840331259124 (WRAPC8-R8F111-PLUS ), 00840331259131 (WRAPC8-R8F111-SF ), 00840331259148 (WRAPC8-R8F111-SM ), 00840331259155 (WRAPC8-R8F111-XLF ), 00840331259162 (WRAPC8-R8F111-XLM ), 00840331270105 (WRAPT18-R8F111-LF ), 00840331270112 (WRAPT18-R8F111-LM ), 00840331270105 (WRAPT18-R8F111-MF ), 00840331270112 (WRAPT18-R8F111-MM ), 00840331270105 (WRAPT18-R8F111-PLUS ), 00840331270105 (WRAPT18-R8F111-SF ), 00840331270112 (WRAPT18-R8F111-SM ), 00840331270105 (WRAPT18-R8F111-XLF ), 00840331270112 (WRAPT18-R8F111-XLM ), 00840331270112 (WRAPT18-R8F111-XSM ), 00840331270105 (WRAPT28-R8F111-2XF ), 00840331270112 (WRAPT28-R8F111-2XM ), 00840331270105 (WRAPT28-R8F111-3XF ), 00840331270112 (WRAPT28-R8F111-3XM ), 00840331270105 (WRAPT28-R8F111-4XF ), 00840331270112 (WRAPT28-R8F111-4XM ), 00840331270105 (WRAPT28-R8F111-5XF ), 00840331270112 (WRAPT28-R8F111-5XM ), 00840331270105 (WRAPT38-R8F111-6XF ), 00840331270112 (WRAPT38-R8F111-6XM ), 00840331270112 (WRAPT38-R8F111-8XM ), None (IWRAPC8-R8F111-MML ). 5. Model Number: R8F112; UDI-DI (Product Code): 00840331259209 (WRAPC18-R8F112-2XF ), 00840331259223 (WRAPC18-R8F112-3XF ), 00840331259247 (WRAPC8-R8F112-LF ), 00840331259254 (WRAPC8-R8F112-LM ), 00840331259261 (WRAPC8-R8F112-MF ), 00840331259278 (WRAPC8-R8F112-MM ), 00840331259292 (WRAPC8-R8F112-SF ), 00840331259308 (WRAPC8-R8F112-SM ), 00840331259315 (WRAPC8-R8F112-XLF ), 00840331259322 (WRAPC8-R8F112-XLM ), 00840331259339 (WRAPC8-R8F112-XSF ), 00840331259346 (WRAPC8-R8F112-XSM ), 00840331270167 (WRAPT18-R8F112-LF ), 00840331270174 (WRAPT18-R8F112-LM ), 00840331270167 (WRAPT18-R8F112-MF ), 00840331270174 (WRAPT18-R8F112-MM ), 00840331270167 (WRAPT18-R8F112-PLUS ), 00840331270167 (WRAPT18-R8F112-SF ), 00840331270174 (WRAPT18-R8F112-SM ), 00840331270167 (WRAPT18-R8F112-XLF ), 00840331270174 (WRAPT18-R8F112-XLM ), 00840331270174 (WRAPT18-R8F112-XSM ), 00840331270174 (WRAPT28-R8F112-2XM ), 00840331270167 (WRAPT28-R8F112-3XF ), 00840331270174 (WRAPT28-R8F112-4XM ), 00840331270167 (WRAPT28-R8F112-5XF ), 00840331270105 (WRAPT38-R8F112-6XF ), 00840331270105 (WRAPT38-R8F112-7XF ), 00840331270112 (WRAPT38-R8F112-7XM ), None (IWRAPC8-R8F112-2XML ), None (IWRAPC8-R8F112-LFR ), None (IWRAPC8-R8F112-LMR ), None (IWRAPC8-R8F112-MFR ), None (IWRAPC8-R8F112-MFS ), None (IWRAPC8-R8F112-MMR ), None (IWRAPC8-R8F112-MMS ), None (IWRAPC8-R8F112-PLUSL ), None (IWRAPC8-R8F112-PLUSR ), None (IWRAPC8-R8F112-SFS ), None (IWRAPC8-R8F112-SMS ), None (IWRAPC8-R8F112-XLFL ), None (IWRAPC8-R8F112-XLML ), None (IWRAPC8-R8F112-XSFS ), None (IWRAPC8-R8F112-XSMS ), None (IWRAPC8-R8F112-MML ). 6. Model Number: R8P600; UDI-DI (Product Code): 00197513001126 (PWRAPC8-R8P600-MD ). 7. Model Number: R8W113; UDI-DI (Product Code): 00197513007906 (WRAPC18-R8W113-2XF ), 00197513007890 (WRAPC18-R8W113-2XM ), 00197513007043 (WRAPC8-R8W113-MF ), 00197513007036 (WRAPC8-R8W113-MM ). 8. Model Number: R8W114; UDI-DI (Product Code): 00197513010210 (WRAPC18-R8W114-2XF ), 00197513010203 (WRAPC18-R8W114-2XM ), 00197513009351 (WRAPC8-R8W114-MF ), 00197513009344 (WRAPC8-R8W114-MM ). 9. Model Number: S8EURO; UDI-DI (Product Code): 00840331262476 (WRAPC18-S8EURO-2XF ), 00840331262483 (WRAPC18-S8EURO-2XM ), 00840331262490 (WRAPC18-S8EURO-3XF ), 00840331262506 (WRAPC18-S8EURO-3XM ), 00840331262513 (WRAPC8-S8EURO-LF ), 00840331262520 (WRAPC8-S8EURO-LM ), 00840331262537 (WRAPC8-S8EURO-MF ), 00840331262544 (WRAPC8-S8EURO-MM ), 00840331262551 (WRAPC8-S8EURO-PLUS ), 00840331262568 (WRAPC8-S8EURO-SF ), 00840331262575 (WRAPC8-S8EURO-SM ), 00840331262582 (WRAPC8-S8EURO-XLF ), 00840331262599 (WRAPC8-S8EURO-XLM ), 00840331262605 (WRAPC8-S8EURO-XSF ), 00840331262612 (WRAPC8-S8EURO-XSM ), 00840331262513 (WRAPS8-S8EURO-LF ), 00840331262520 (WRAPS8-S8EURO-LM ), 00840331262537 (WRAPS8-S8EURO-MF ), 00840331262544 (WRAPS8-S8EURO-MM ), 00840331262568 (WRAPS8-S8EURO-SF ), 00840331262575 (WRAPS8-S8EURO-SM ), 00840331262599 (WRAPS8-S8EURO-XLM ), 00840331270068 (WRAPT18-S8EURO-LF ), 00840331270075 (WRAPT18-S8EURO-LM ), 00840331270068 (WRAPT18-S8EURO-MF ), 00840331270075 (WRAPT18-S8EURO-MM ), 00840331270068 (WRAPT18-S8EURO-PLUS ), 00840331270068 (WRAPT18-S8EURO-SF ), 00840331270075 (WRAPT18-S8EURO-SM ), 00840331270068 (WRAPT18-S8EURO-XLF ), 00840331270075 (WRAPT18-S8EURO-XLM ), 00840331270068 (WRAPT18-S8EURO-XSF ), 00840331270075 (WRAPT18-S8EURO-XSM ), 00840331270068 (WRAPT28-S8EURO-2XF ), 00840331270075 (WRAPT28-S8EURO-2XM ), 00840331270068 (WRAPT28-S8EURO-3XF ), 00840331270075 (WRAPT28-S8EURO-3XM ), 00840331270068 (WRAPT28-S8EURO-4XF ), 00840331270075 (WRAPT28-S8EURO-4XM ), 00840331270068 (WRAPT28-S8EURO-5XF ), 00840331270075 (WRAPT28-S8EURO-5XM ), 00840331270068 (WRAPT38-S8EURO-6XF ), 00840331270075 (WRAPT38-S8EURO-6XM ), 00840331270068 (WRAPT38-S8EURO-7XF ), 00840331270075 (WRAPT38-S8EURO-7XM ), 00840331270068 (WRAPT38-S8EURO-8XF ), 00840331270075 (WRAPT38-S8EURO-8XM ). 10. Model Number: S8F111; UDI-DI (Product Code): 00840331262797 (WRAPC18-S8F111-2XF ), 00840331262803 (WRAPC18-S8F111-2XM ), 00840331262834 (WRAPC8-S8F111-LF ), 00840331262841 (WRAPC8-S8F111-LM ), 00840331262841 (WRAPC8-S8F111-MF ), 00840331262865 (WRAPC8-S8F111-MM ), 00840331262872 (WRAPC8-S8F111-PLUS ), 00840331262889 (WRAPC8-S8F111-SF ), 00840331262896 (WRAPC8-S8F111-SM ), 00840331262902 (WRAPC8-S8F111-XLF ), 00840331262919 (WRAPC8-S8F111-XLM ), 00840331270129 (WRAPT18-S8F111-LF ), 00840331270136 (WRAPT18-S8F111-LM ), 00840331270129 (WRAPT18-S8F111-MF ), 00840331270136 (WRAPT18-S8F111-MM ), 00840331270129 (WRAPT18-S8F111-PLUS ), 00840331270129 (WRAPT18-S8F111-SF ), 00840331270136 (WRAPT18-S8F111-SM ), 00840331270129 (WRAPT18-S8F111-XLF ), 00840331270136 (WRAPT18-S8F111-XLM ), 00840331270136 (WRAPT18-S8F111-XSM ), 00840331270129 (WRAPT28-S8F111-2XF ), 00840331270136 (WRAPT28-S8F111-2XM ), 00840331270129 (WRAPT28-S8F111-3XF ), 00840331270136 (WRAPT28-S8F111-3XM ), 00840331270129 (WRAPT28-S8F111-4XF ), 00840331270136 (WRAPT28-S8F111-4XM ), 00840331270129 (WRAPT28-S8F111-5XF ), 00840331270136 (WRAPT28-S8F111-5XM ), 00840331270129 (WRAPT38-S8F111-6XF ), 00840331270136 (WRAPT38-S8F111-6XM ), 00840331270129 (WRAPT38-S8F111-8XF ), 00840331270136 (WRAPT38-S8F111-8XM ). 11. Model Number: S8F112; UDI-DI (Product Code): 00840331262964 (WRAPC18-S8F112-2XM ), 00840331262995 (WRAPC8-S8F112-LF ), 00840331263008 (WRAPC8-S8F112-LM ), 00840331263015 (WRAPC8-S8F112-MF ), 00840331263022 (WRAPC8-S8F112-MM ), 00840331263046 (WRAPC8-S8F112-SF ), 00840331263053 (WRAPC8-S8F112-SM ), 00840331263077 (WRAPC8-S8F112-XLM ), 00840331270181 (WRAPT18-S8F112-LF ), 00840331270198 (WRAPT18-S8F112-LM ), 00840331270181 (WRAPT18-S8F112-MF ), 00840331270198 (WRAPT18-S8F112-MM ), 00840331270181 (WRAPT18-S8F112-PLUS ), 00840331270198 (WRAPT18-S8F112-SM ), 00840331270181 (WRAPT18-S8F112-XLF ), 00840331270198 (WRAPT18-S8F112-XLM ), 00840331270181 (WRAPT28-S8F112-2XF ), 00840331270198 (WRAPT28-S8F112-2XM ), 00840331270198 (WRAPT28-S8F112-3XM ), 00840331270181 (WRAPT28-S8F112-4XF ), 00840331270198 (WRAPT28-S8F112-5XM ). 12. Model Number: S8W113; UDI-DI (Product Code): 00197513000594 (WRAPT28-S8W113-3XF ). 13. Model Number: U8EURO; UDI-DI (Product Code): 00840331266207 (WRAPC18-U8EURO-2XF ), 00840331266214 (WRAPC18-U8EURO-2XM ), 00840331266245 (WRAPC8-U8EURO-LF ), 00840331266252 (WRAPC8-U8EURO-LM ), 00840331266269 (WRAPC8-U8EURO-MF ), 00840331266269 (WRAPC8-U8EURO-MM ), 00840331266283 (WRAPC8-U8EURO-PLUS ), 00840331266306 (WRAPC8-U8EURO-SM ), 00840331266313 (WRAPC8-U8EURO-XLF ), 00840331266320 (WRAPC8-U8EURO-XLM ), 00840331266337 (WRAPC8-U8EURO-XSF ), 00840331266344 (WRAPC8-U8EURO-XSM ), 00840331266245 (WRAPS8-U8EURO-LF ), 00840331266252 (WRAPS8-U8EURO-LM ), 00840331266269 (WRAPS8-U8EURO-MF ), 00840331266276 (WRAPS8-U8EURO-MM ), 00840331266306 (WRAPS8-U8EURO-SM ), 00840331266320 (WRAPS8-U8EURO-XLM ), 00840331270082 (WRAPT18-U8EURO-LF ), 00840331270099 (WRAPT18-U8EURO-LM ), 00840331270082 (WRAPT18-U8EURO-MF ), 00840331270099 (WRAPT18-U8EURO-MM ), 00840331270082 (WRAPT18-U8EURO-PLUS ), 00840331270082 (WRAPT18-U8EURO-SF ), 00840331270099 (WRAPT18-U8EURO-SM ), 00840331270082 (WRAPT18-U8EURO-XLF ), 00840331270099 (WRAPT18-U8EURO-XLM ), 00840331270099 (WRAPT18-U8EURO-XSM ), 00840331270082 (WRAPT28-U8EURO-2XF ), 00840331270099 (WRAPT28-U8EURO-2XM ), 00840331270082 (WRAPT28-U8EURO-3XF ), 00840331270099 (WRAPT28-U8EURO-3XM ), 00840331270082 (WRAPT28-U8EURO-4XF ), 00840331270099 (WRAPT28-U8EURO-4XM ), 00840331270082 (WRAPT28-U8EURO-5XF ), 00840331270099 (WRAPT28-U8EURO-5XM ), 00840331270082 (WRAPT38-U8EURO-6XF ), 00840331270099 (WRAPT38-U8EURO-6XM ), 00840331270082 (WRAPT38-U8EURO-7XF ), 00840331270099 (WRAPT38-U8EURO-7XM ), 00840331270099 (WRAPT38-U8EURO-8XM ). 14. Model Number: U8F111; UDI-DI (Product Code): 00840331266566 (WRAPC8-U8F111-LF ), 00840331266573 (WRAPC8-U8F111-LM ), 00840331266580 (WRAPC8-U8F111-MF ), 00840331266597 (WRAPC8-U8F111-MM ), 00840331266603 (WRAPC8-U8F111-PLUS ), 00840331266634 (WRAPC8-U8F111-XLF ), 00840331266641 (WRAPC8-U8F111-XLM ), 00840331270143 (WRAPT18-U8F111-LF ), 00840331270150 (WRAPT18-U8F111-LM ), 00840331270143 (WRAPT18-U8F111-MF ), 00840331270150 (WRAPT18-U8F111-MM ), 00840331270143 (WRAPT18-U8F111-PLUS ), 00840331270150 (WRAPT18-U8F111-SM ), 00840331270143 (WRAPT18-U8F111-XLF ), 00840331270150 (WRAPT18-U8F111-XLM ), 00840331270143 (WRAPT28-U8F111-2XF ), 00840331270150 (WRAPT28-U8F111-2XM ), 00840331270150 (WRAPT28-U8F111-3XM ), 00840331270143 (WRAPT28-U8F111-4XF ), 00840331270150 (WRAPT28-U8F111-4XM ), 00840331270143 (WRAPT28-U8F111-5XF ), 00840331270143 (WRAPT38-U8F111-6XF ), 00840331270150 (WRAPT38-U8F111-6XM ), 00840331270143 (WRAPT38-U8F111-7XF ), None (IWRAPC8-U8F111-2XMR ), None (IWRAPC8-U8F111-LMR ), None (IWRAPC8-U8F111-MMR ), None (IWRAPC8-U8F111-SMR ), None (IWRAPC8-U8F111-XLMR ). 15. Model Number: U8F112; UDI-DI (Product Code): 00840331266740 (WRAPC8-U8F112-MF ), 00840331270211 (WRAPT18-U8F112-MM ), 00840331270211 (WRAPT18-U8F112-XLM ), 00840331270211 (WRAPT28-U8F112-4XM ), 00840331270204 (WRAPT28-U8F112-5XF ), None (IWRAPC8-U8F112-2XMR ), None (IWRAPC8-U8F112-LMR ), None (IWRAPC8-U8F112-MMR ), None (IWRAPC8-U8F112-SMR ), None (IWRAPC8-U8F112-XLMR ), None (IWRAPC8-U8F112-XLMXL ). 16. Model Number: U8W113; UDI-DI (Product Code): 00197513000587 (WRAPT28-U8W113-3XF ). 17. Model Number: R8EURO; UDI-DI (Product Code): None (IWRAPC8-R8EURO-LMR).

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.

device · product 6 of 13

Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.

Z-1758-2026

Recall number: Z-1758-2026
Initiated: February 11, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Burlington Medical, LLC
Quantity: 1,489 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for attenuation degradation over time, decreasing the lifespan.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for attenuation degradation over time, decreasing the lifespan.

Code information

All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: BATB; UDI-DI (Product Code): 00197513011941 (BATC18-R8BATB-2XF ), 00197513011941 (BATC18-R8BATB-3XF ), 00197513011941 (BATC8-R8BATB-LF ), 00197513011941 (BATC8-R8BATB-LM ), 00197513011941 (BATC8-R8BATB-MF ), 00197513011941 (BATC8-R8BATB-MM ), 00197513011941 (BATC8-R8BATB-PLUS ), 00197513011941 (BATC8-R8BATB-SF ), 00197513011941 (BATC8-R8BATB-XLF ), 00197513011941 (BATC8-R8BATB-XLM ), 00197513011941 (BATC8-R8BATB-XSF ). 2. Model Number: BATH; UDI-DI (Product Code): 00197513011934 (BATC18-R8BATH-2XF ), 00197513011934 (BATC18-R8BATH-2XM ), 00197513011934 (BATC18-R8BATH-3XF ), 00197513011934 (BATC18-R8BATH-3XM ), 00197513011934 (BATC8-R8BATH-LF ), 00197513011934 (BATC8-R8BATH-LM ), 00197513011934 (BATC8-R8BATH-MF ), 00197513011934 (BATC8-R8BATH-MM ), 00197513011934 (BATC8-R8BATH-PLUS ), 00197513011934 (BATC8-R8BATH-SF ), 00197513011934 (BATC8-R8BATH-SM ), 00197513011934 (BATC8-R8BATH-XLF ), 00197513011934 (BATC8-R8BATH-XLM ), 00197513011934 (BATC8-R8BATH-XSF ), 00197513011934 (BATC8-R8BATH-XLF ). 3. Model Number: BATM; UDI-DI (Product Code): 00197513011927 (BATC18-R8BATM-2XF ), 00197513011927 (BATC18-R8BATM-2XM ), 00197513011927 (BATC18-R8BATM-3XF ), 00197513011927 (BATC18-R8BATM-3XM ), 00197513011927 (BATC8-R8BATM-LF ), 00197513011927 (BATC8-R8BATM-LM ), 00197513011927 (BATC8-R8BATM-MF ), 00197513011927 (BATC8-R8BATM-MM ), 00197513011927 (BATC8-R8BATM-PLUS ), 00197513011927 (BATC8-R8BATM-SF ), 00197513011927 (BATC8-R8BATM-SM ), 00197513011927 (BATC8-R8BATM-XLF ), 00197513011927 (BATC8-R8BATM-XLM ), 00197513011927 (BATC8-R8BATM-XSF ), 00197513011927 (BATC8-R8BATM-XSM ).

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.

device · product 7 of 13

Burlington Medical, Protective Sleeves.

Z-1759-2026

Recall number: Z-1759-2026
Initiated: February 11, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Burlington Medical, LLC
Quantity: 1,129 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for attenuation degradation over time, decreasing the lifespan.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for attenuation degradation over time, decreasing the lifespan.

Code information

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).

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.

device · product 8 of 13

Burlington Medical, Caps.

Z-1760-2026

Recall number: Z-1760-2026
Initiated: February 11, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Burlington Medical, LLC
Quantity: 961 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for attenuation degradation over time, decreasing the lifespan.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for attenuation degradation over time, decreasing the lifespan.

Code information

All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8CAP; UDI-DI (Product Code): 00840331272185 (CAP8-R8CAP-LG_XL), 00840331272178 (CAP8-R8CAP-SM_MD). 2. Model Number: S8CAP; UDI-DI (Product Code): 00840331272208 (CAP8-S8CAP-LG_XL), 00840331272192 (CAP8-S8CAP-SM_MD). 3.Model Number: U8CAP; UDI-DI (Product Code): 00840331272222 (CAP8-U8CAP-LG_XL), 00840331272215 (CAP8-U8CAP-SM_MD).

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.

device · product 9 of 13

Burlington Medical, Leg Wraps.

Z-1761-2026

Recall number: Z-1761-2026
Initiated: February 11, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Burlington Medical, LLC
Quantity: 103 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for attenuation degradation over time, decreasing the lifespan.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for attenuation degradation over time, decreasing the lifespan.

Code information

All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8LGW1; UDI-DI (Product Code): 00840331272079 (LGW8SET-R8LGW1). 2. Model Number: R8LGW2; UDI-DI (Product Code): 00840331272086 (LGW8SET-R8LGW2). 3. Model Number: R8LGW3; UDI-DI (Product Code): 00840331272055 (LGW8SET-R8LGW3). 4. Model Number: S8LGW1; UDI-DI (Product Code): 00840331272116 (LGW8SET-S8LGW1). 5. Model Number: S8LGW2; UDI-DI (Product Code): 00840331272123 (LGW8SET-S8LGW2). 6. Model Number: S8LGW3; UDI-DI (Product Code): 00840331272093 (LGW8SET-S8LGW3). 7. Model Number: S8LGW4; UDI-DI (Product Code): 00840331272109 (LGW8SET-S8LGW4). 8. Model Number: U8LGW1; UDI-DI (Product Code): 00840331272154 (LGW8SET-U8LGW1). 9. Model Number: U8LGW2; UDI-DI (Product Code): 00840331272161 (LGW8SET-U8LGW2). 10. Model Number: U8LGW4; UDI-DI (Product Code): 00840331272147 (LGW8SET-U8LGW4).

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.

device · product 10 of 13

Burlington Medical, Half Aprons.

Z-1762-2026

Recall number: Z-1762-2026
Initiated: February 11, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Burlington Medical, LLC
Quantity: 402 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for attenuation degradation over time, decreasing the lifespan.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for attenuation degradation over time, decreasing the lifespan.

Code information

All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8HALF1B; UDI-DI (Product Code): 00840331272291 (HALF18-R8HALF1B). 2. Model Number: R8HALF1H; UDI-DI (Product Code): 00840331272314 (HALF18-R8HALF1H). 3. Model Number: R8HALF2B; UDI-DI (Product Code): 00840331272338 (HALF28-R8HALF2B). 4. Model Number: R8HALF2H; UDI-DI (Product Code): 00840331272345 (HALF28-R8HALF2H). 5. Model Number: R8HALF3B; UDI-DI (Product Code): 00840331272352 (HALF38-R8HALF3B). 6. Model Number: R8HALF3H; UDI-DI (Product Code): 00840331272369 (HALF38-R8HALF3H). 7. Model Number: R8HALF4B; UDI-DI (Product Code): 00840331272376 (HALF48-R8HALF4B). 8. Model Number: R8HALF4H; UDI-DI (Product Code): 00840331272383 (HALF48-R8HALF4H). 9. Model Number: R8HALF5B; UDI-DI (Product Code): 00840331272390 (HALF58-R8HALF5B). 10. Model Number: R8HALF5H; UDI-DI (Product Code): 00840331272406 (HALF58-R8HALF5H). 11. Model Number: R8HALF6B; UDI-DI (Product Code): 00840331272420 (HALF68-R8HALF6B). 12. Model Number: R8HALF6H; UDI-DI (Product Code): 00840331272352 (HALF68-R8HALF6H). 13. Model Number: R8HALFSETB; UDI-DI (Product Code): 00840331272413 (HALFSET8-R8HALFSETB). 14. Model Number: R8HALFSETH; UDI-DI (Product Code): 00840331272420 (HALFSET8-R8HALFSETH). 15. Model Number: S8HALF1H; UDI-DI (Product Code): 00840331272451 (HALF18-S8HALF1H). 16. Model Number: S8HALF2B; UDI-DI (Product Code): 00840331272475 (HALF28-S8HALF2B). 17. Model Number: S8HALF2H; UDI-DI (Product Code): 00840331272482 (HALF28-S8HALF2H). 18. Model Number: S8HALF3B; UDI-DI (Product Code): 00840331272499 (HALF38-S8HALF3B). 19. Model Number: S8HALF3H; UDI-DI (Product Code): 00840331272505 (HALF38-S8HALF3H). 20. Model Number: S8HALF4B; UDI-DI (Product Code): 00840331272512 (HALF48-S8HALF4B). 21. Model Number: S8HALF4H; UDI-DI (Product Code): 00840331272529 (HALF48-S8HALF4H). 22. Model Number: S8HALF5B; UDI-DI (Product Code): 00840331272536 (HALF58-S8HALF5B). 23. Model Number: S8HALF5H; UDI-DI (Product Code): 00840331272543 (HALF58-S8HALF5H). 24. Model Number: S8HALF6H; UDI-DI (Product Code): 00840331272499 (HALF68-S8HALF6H). 25. Model Number: S8HALFSETH; UDI-DI (Product Code): 00840331272567 (HALFSET8-S8HALFSETH). 26. Model Number: U8HALF3B; UDI-DI (Product Code): 00840331272635 (HALF38-U8HALF3B). 27. Model Number: U8HALF3H; UDI-DI (Product Code): 00840331272642 (HALF38-U8HALF3H). 28. Model Number: U8HALF4H; UDI-DI (Product Code): 00840331272666 (HALF48-U8HALF4H). 29. Model Number: U8HALF5H; UDI-DI (Product Code): 00840331272680 (HALF58-U8HALF5H). 30. Model Number: U8HALF6H; UDI-DI (Product Code): 00840331272635 (HALF68-U8HALF6H).

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.

device · product 11 of 13

Burlington Medical, Demi Half Aprons.

Z-1763-2026

Recall number: Z-1763-2026
Initiated: February 11, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Burlington Medical, LLC
Quantity: 29 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for attenuation degradation over time, decreasing the lifespan.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for attenuation degradation over time, decreasing the lifespan.

Code information

All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8DHALFR; UDI-DI (Product Code): 00197513001485 (DHALF8-R8DHALFR-L), 00197513001478 (DHALF8-R8DHALFR-M), 00197513001461 (DHALF8-R8DHALFR-S), 00197513001492 (DHALF8-R8DHALFR-XL), 00197513001607 (DHALFSET8-R8DHALFR-SET).

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.

device · product 12 of 13

Burlington Medical, Blockers.

Z-1764-2026

Recall number: Z-1764-2026
Initiated: February 11, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Burlington Medical, LLC
Quantity: 51 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for attenuation degradation over time, decreasing the lifespan.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for attenuation degradation over time, decreasing the lifespan.

Code information

All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8BLOCKER1; UDI-DI (Product Code): 00840331272895 (BLOCKER8-R8BLOCKER1). 2. Model Number: R8BLOCKER2; UDI-DI (Product Code): 00840331272901 (BLOCKER8-R8BLOCKER2). 3. Model Number: R8BLOCKER3; UDI-DI (Product Code): 00840331272918 (BLOCKER8-R8BLOCKER3). 4. Model Number: R8BLOCKER4; UDI-DI (Product Code): 00840331272932 (BLOCKER8-R8BLOCKER4). 5. Model Number: R8BLOCKER5; UDI-DI (Product Code): 00840331272949 (BLOCKER8-R8BLOCKER5). 6. Model Number: R8BLOCKER6; UDI-DI (Product Code): 00840331272956 (BLOCKER8-R8BLOCKER6). 7. Model Number: S8BLOCKER1; UDI-DI (Product Code): 00840331272963 (BLOCKER8-S8BLOCKER1). 8. Model Number: S8BLOCKER2; UDI-DI (Product Code): 00840331272970 (BLOCKER8-S8BLOCKER2). 9. Model Number: S8BLOCKER3; UDI-DI (Product Code): 00840331272987 (BLOCKER8-S8BLOCKER3). 10. Model Number: U8BLOCKER1; UDI-DI (Product Code): 00840331273038 (BLOCKER8-U8BLOCKER1).

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.

device · product 13 of 13

Burlington Medical, Kilt Blockers.

Z-1765-2026

Recall number: Z-1765-2026
Initiated: February 11, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Burlington Medical, LLC
Quantity: 94 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for attenuation degradation over time, decreasing the lifespan.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for attenuation degradation over time, decreasing the lifespan.

Code information

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).

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.

Event summary

Source snapshots represented here

Every recalled product in this event

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