Skip to content
RecallWatchMedical Device Safety
Class IIOngoingZ-1753-2026

Burlington Medical, LLC recalls Burlington Medical

Burlington Medical, LLCNewport News, VA, United StatesReported Apr 8, 2026 · 3 months ago
Legal News Analyst ·

Reason for recall

Potential for attenuation degradation over time, decreasing the lifespan.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Burlington Medical, Thyroid Shield.

Lot / code information

Serial #
are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1
Model
R8COPEH
UDI
(Product Code): 00840331299052 (COPE-R8COPEH-LG). 2
Model
R8TSBBB
UDI
(Product Code): 00840331260311 (THYROIDSHIELDO8-R8TSBBB-SM). 3
Model
R8TSBBN
UDI
00840331260328; Product Codes: THYROIDSHIELDO8-R8TSBBN-LG, THYROIDSHIELDO8-R8TSBBN-MD, THYROIDSHIELDO8-R8TSBBN-SM. 4
Model
R8TSBBR
UDI
(Product Code): 00840331260359 (THYROIDSHIELDO8-R8TSBBR-LG), 00840331260366 (THYROIDSHIELDO8-R8TSBBR-MD), 00840331260373 (THYROIDSHIELDO8-R8TSBBR-SM). 5
Model
R8TSBBT
Show 207 more code fields
UDI
(Product Code): 00840331260397 (THYROIDSHIELDO8-R8TSBBT-MD), 00840331260403 (THYROIDSHIELDO8-R8TSBBT-SM). 6
Model
R8TSBHB
UDI
(Product Code): 00840331295948 (THYROIDSHIELDO8-R8TSBHB-MD), 00840331295955 (THYROIDSHIELDO8-R8TSBHB-SM). 7
Model
R8TSBHN
UDI
(Product Code): 00840331260427 (THYROIDSHIELDO8-R8TSBHN-MD ), 00840331260434 (THYROIDSHIELDO8-R8TSBHN-SM ). 8
Model
R8TSBHR
UDI
(Product Code): 00840331260465 (THYROIDSHIELDO8-R8TSBHR-SM ), 00840331260458 (THYROIDSHIELDO8-R8TSBHR-MD ), 00840331260441 (THYROIDSHIELDO8-R8TSBHR-LG ). 9
Model
R8TSBHT
UDI
(Product Code): 00840331260489 (THYROIDSHIELDO8-R8TSBHT-MD ), 00840331260496 (THYROIDSHIELDO8-R8TSBHT-SM ). 10
Model
R8TSBMB
UDI
(Product Code): 00840331295979 (THYROIDSHIELDOM8-R8TSBMB-MD ), 00840331295986 (THYROIDSHIELDOM8-R8TSBMB-SM ). 11
Model
R8TSBMN
UDI
(Product Code): 00840331260519 (THYROIDSHIELDOM8-R8TSBMN-MD ). 12
Model
R8TSBMR
UDI
(Product Code): 00840331260533 (THYROIDSHIELDOM8-R8TSBMR-LG ), 00840331260540 (THYROIDSHIELDOM8-R8TSBMR-MD ), 00840331260557 (THYROIDSHIELDOM8-R8TSBMR-SM ). 13
Model
R8TSBMT
UDI
(Product Code): 00840331260571 (THYROIDSHIELDOM8-R8TSBMT-MD ). 14
Model
R8TSCBB
UDI
(Product Code): 00840331270525 (THYROIDSHIELD8-R8TSCBB-LG ), 00840331270532 (THYROIDSHIELD8-R8TSCBB-MD ), 00840331270549 (THYROIDSHIELD8-R8TSCBB-SM ). 15
Model
R8TSCBN
UDI
(Product Code): 00840331260595 (THYROIDSHIELD8-R8TSCBN-LG ), 00840331260601 (THYROIDSHIELD8-R8TSCBN-MD ), 00840331260618 (THYROIDSHIELD8-R8TSCBN-SM ). 16
Model
R8TSCBR
UDI
(Product Code): 00840331260625 (THYROIDSHIELD8-R8TSCBR-LG ), 00840331260632 (THYROIDSHIELD8-R8TSCBR-MD ), 00840331260649 (THYROIDSHIELD8-R8TSCBR-SM ). 17
Model
R8TSCBS
UDI
(Product Code): 00840331270594 (THYROIDSHIELD8-R8TSCBS-MD ), 00840331270587 (THYROIDSHIELD8-R8TSCBS-SM ). 18
Model
R8TSCBT
UDI
(Product Code): 00840331260656 (THYROIDSHIELD8-R8TSCBT-LG ), 00840331260663 (THYROIDSHIELD8-R8TSCBT-MD ), 00840331260670 (THYROIDSHIELD8-R8TSCBT-SM ). 19
Model
R8TSCHB
UDI
(Product Code): 00840331270495 (THYROIDSHIELD8-R8TSCHB-LG ), 00840331270501 (THYROIDSHIELD8-R8TSCHB-MD ), 00840331270518 (THYROIDSHIELD8-R8TSCHB-SM ). 20
Model
R8TSCHN
UDI
(Product Code): 00840331260687 (THYROIDSHIELD8-R8TSCHN-LG ), 00840331260694 (THYROIDSHIELD8-R8TSCHN-MD ), 00840331260700 (THYROIDSHIELD8-R8TSCHN-SM ). 21
Model
R8TSCHR
UDI
(Product Code): 00840331260717 (THYROIDSHIELD8-R8TSCHR-LG ), 00840331260724 (THYROIDSHIELD8-R8TSCHR-MD ), 00840331260731 (THYROIDSHIELD8-R8TSCHR-SM ). 22
Model
R8TSCHS
UDI
(Product Code): 00840331270563 (THYROIDSHIELD8-R8TSCHS-MD ), 00840331270556 (THYROIDSHIELD8-R8TSCHS-SM ). 23
Model
R8TSCHT
UDI
(Product Code): 00840331260748 (THYROIDSHIELD8-R8TSCHT-LG ), 00840331260755 (THYROIDSHIELD8-R8TSCHT-MD ), 00840331260762 (THYROIDSHIELD8-R8TSCHT-SM ). 24
Model
R8TSCMB
UDI
(Product Code): 00840331270464 (THYROIDSHIELDM8-R8TSCMB-LG ), 00840331270471 (THYROIDSHIELDM8-R8TSCMB-MD ), 00840331270488 (THYROIDSHIELDM8-R8TSCMB-SM ). 25
Model
R8TSCMN
UDI
(Product Code): 00840331260786 (THYROIDSHIELDM8-R8TSCMN-MD ), 00840331260793 (THYROIDSHIELDM8-R8TSCMN-SM ). 26
Model
R8TSCMR
UDI
(Product Code): 00840331260809 (THYROIDSHIELDM8-R8TSCMR-LG ), 00840331260816 (THYROIDSHIELDM8-R8TSCMR-MD ), 00840331260823 (THYROIDSHIELDM8-R8TSCMR-SM ). 27
Model
R8TSCMS
UDI
(Product Code): 00840331260830 (THYROIDSHIELDM8-R8TSCMS-MD ), 00840331260847 (THYROIDSHIELDM8-R8TSCMS-SM ). 28
Model
R8TSCMT
UDI
(Product Code): 00840331260854 (THYROIDSHIELDM8-R8TSCMT-LG ), 00840331260861 (THYROIDSHIELDM8-R8TSCMT-MD ), 00840331260878 (THYROIDSHIELDM8-R8TSCMT-SM ). 29
Model
R8TSOBB
UDI
(Product Code): 00840331271430 (THYROIDSHIELDO8-R8TSOBB-MD ). 30
Model
R8TSOBN
UDI
(Product Code): 00840331260892 (THYROIDSHIELDO8-R8TSOBN-MD ). 31
Model
R8TSOBR
UDI
(Product Code): 00840331260922 (THYROIDSHIELDO8-R8TSOBR-MD ), 00840331260939 (THYROIDSHIELDO8-R8TSOBR-SM ). 32
Model
R8TSOHB
UDI
(Product Code): 00840331260939 (THYROIDSHIELDO8-R8TSOHB-MD, THYROIDSHIELDO8-R8TSOHB-SM ). 33
Model
R8TSOHR
UDI
(Product Code): 00840331261011 (THYROIDSHIELDO8-R8TSOHR-MD ), 00840331261028 (THYROIDSHIELDO8-R8TSOHR-SM ). 34
Model
R8TSOHT
UDI
(Product Code): 00840331261035 (THYROIDSHIELDO8-R8TSOHT-LG ). 35
Model
R8TSOMN
UDI
(Product Code): 00840331261080 (THYROIDSHIELDOM8-R8TSOMN-SM ). 36
Model
R8TSOMR
UDI
(Product Code): 00840331261097 (THYROIDSHIELDOM8-R8TSOMR-LG ), 00840331261103 (THYROIDSHIELDOM8-R8TSOMR-MD ), 00840331261110 (THYROIDSHIELDOM8-R8TSOMR-SM ). 37
Model
R8TSOMT
UDI
(Product Code): 00840331261141 (THYROIDSHIELDOM8-R8TSOMT-SM ). 38
Model
R8TSSBB
UDI
(Product Code): 00840331270976 (THYROIDSHIELD8-R8TSSBB-LG ), 00840331270983 (THYROIDSHIELD8-R8TSSBB-MD ), 00840331270990 (THYROIDSHIELD8-R8TSSBB-SM ). 39
Model
R8TSSBN
UDI
(Product Code): 00840331261165 (THYROIDSHIELD8-R8TSSBN-MD ), 00840331261172 (THYROIDSHIELD8-R8TSSBN-SM ), None (THYROIDSHIELDP8-R8TSSBN-PD ). 40
Model
R8TSSBR
UDI
(Product Code): 00840331261189 (THYROIDSHIELD8-R8TSSBR-LG ), 00840331261196 (THYROIDSHIELD8-R8TSSBR-MD ), 00840331261202 (THYROIDSHIELD8-R8TSSBR-SM ). 41
Model
R8TSSBS
UDI
(Product Code): 00840331271041 (THYROIDSHIELD8-R8TSSBS-MD ), 00840331271034 (THYROIDSHIELD8-R8TSSBS-SM ). 42
Model
R8TSSBT
UDI
(Product Code): 00840331261226 (THYROIDSHIELD8-R8TSSBT-MD ). 43
Model
R8TSSHB
UDI
(Product Code): 00840331270952 (THYROIDSHIELD8-R8TSSHB-MD ), 00840331270969 (THYROIDSHIELD8-R8TSSHB-SM ). 44
Model
R8TSSHN
UDI
(Product Code): 00840331261257 (THYROIDSHIELD8-R8TSSHN-MD ), 00840331261264 (THYROIDSHIELD8-R8TSSHN-SM ). 45
Model
R8TSSHR
UDI
(Product Code): 00840331261271 (THYROIDSHIELD8-R8TSSHR-LG ), 00840331261288 (THYROIDSHIELD8-R8TSSHR-MD ), 00840331261295 (THYROIDSHIELD8-R8TSSHR-SM ). 46
Model
R8TSSHS
UDI
(Product Code): 00840331271010 (THYROIDSHIELD8-R8TSSHS-MD ), 00840331271003 (THYROIDSHIELD8-R8TSSHS-SM ). 47
Model
R8TSSHT
UDI
(Product Code): 00840331261318 (THYROIDSHIELD8-R8TSSHT-MD ), 00840331261325 (THYROIDSHIELD8-R8TSSHT-SM ). 48
Model
R8TSSMB
UDI
(Product Code): 00840331270921 (THYROIDSHIELDM8-R8TSSMB-MD ), 00840331270938 (THYROIDSHIELDM8-R8TSSMB-SM ). 49
Model
R8TSSMN
UDI
(Product Code): 00840331261349 (THYROIDSHIELDM8-R8TSSMN-MD ), 00840331261356 (THYROIDSHIELDM8-R8TSSMN-SM ). 50
Model
R8TSSMR
UDI
(Product Code): 00840331261363 (THYROIDSHIELDM8-R8TSSMR-LG ), 00840331261370 (THYROIDSHIELDM8-R8TSSMR-MD ), 00840331261387 (THYROIDSHIELDM8-R8TSSMR-SM ). 51
Model
R8TSSMS
UDI
(Product Code): (THYROIDSHIELDM8-R8TSSMS-MD ), (THYROIDSHIELDM8-R8TSSMS-SM ). 52
Model
R8TSSMT
UDI
(Product Code): 00840331261400 (THYROIDSHIELDM8-R8TSSMT-MD ), 00840331261417 (THYROIDSHIELDM8-R8TSSMT-SM ). 53
Model
R8TSVBN
UDI
(Product Code): 00840331261431 (THYROIDSHIELD8-R8TSVBN-MD ). 54
Model
R8TSVBR
UDI
(Product Code): 00840331261462 (THYROIDSHIELD8-R8TSVBR-MD ), 00840331261479 (THYROIDSHIELD8-R8TSVBR-SM ). 55
Model
R8TSVHR
UDI
(Product Code): 00840331261547 (THYROIDSHIELD8-R8TSVHR-LG ), 00840331261554 (THYROIDSHIELD8-R8TSVHR-MD ), 00840331261561 (THYROIDSHIELD8-R8TSVHR-SM ). 56
Model
R8TSVHT
UDI
(Product Code): 00840331261561 (THYROIDSHIELD8-R8TSVHT-MD ), 00840331261622 (THYROIDSHIELD8-R8TSVHT-SM ). 57
Model
R8TSVMN
UDI
(Product Code): 00840331261646 (THYROIDSHIELDM8-R8TSVMN-MD ), 00840331261653 (THYROIDSHIELDM8-R8TSVMN-SM ). 58
Model
R8TSVMR
UDI
(Product Code): 00840331261660 (THYROIDSHIELDM8-R8TSVMR-LG ), 00840331261677 (THYROIDSHIELDM8-R8TSVMR-MD ), 00840331261684 (THYROIDSHIELDM8-R8TSVMR-SM ). 59
Model
R8TSVMT
UDI
(Product Code): 00840331261738 (THYROIDSHIELDM8-R8TSVMT-MD ), 00840331261745 (THYROIDSHIELDM8-R8TSVMT-SM ). 60
Model
S8TSBHR
UDI
(Product Code): 00840331296006 (THYROIDSHIELDO8-S8TSBHR-MD ). 61
Model
S8TSBHT
UDI
(Product Code): 00840331264197 (THYROIDSHIELDO8-S8TSBHT-LG ). 62
Model
S8TSBMB
UDI
(Product Code): 00840331264265 (THYROIDSHIELDOM8-S8TSBMB-MD ). 63
Model
S8TSBMR
UDI
(Product Code): 00840331264265 (THYROIDSHIELDOM8-S8TSBMR-MD ), 00840331264272 (THYROIDSHIELDOM8-S8TSBMR-SM ). 64
Model
S8TSCBB
UDI
(Product Code): 00840331270693 (THYROIDSHIELD8-S8TSCBB-SM ). 65
Model
S8TSCBN
UDI
(Product Code): 00840331264326 (THYROIDSHIELD8-S8TSCBN-MD ). 66
Model
S8TSCBR
UDI
(Product Code): 00840331264340 (THYROIDSHIELD8-S8TSCBR-LG ), 00840331264357 (THYROIDSHIELD8-S8TSCBR-MD ), 00840331264364 (THYROIDSHIELD8-S8TSCBR-SM ). 67
Model
S8TSCBT
UDI
(Product Code): 00840331264388 (THYROIDSHIELD8-S8TSCBT-MD ), 00840331264395 (THYROIDSHIELD8-S8TSCBT-SM ). 68
Model
S8TSCHN
UDI
(Product Code): 00840331264401 (THYROIDSHIELD8-S8TSCHN-LG ), 00840331264418 (THYROIDSHIELD8-S8TSCHN-MD ). 69
Model
S8TSCHR
UDI
(Product Code): 00840331264432 (THYROIDSHIELD8-S8TSCHR-LG ), 00840331264449 (THYROIDSHIELD8-S8TSCHR-MD ), 00840331264456 (THYROIDSHIELD8-S8TSCHR-SM ). 70
Model
S8TSCHT
UDI
(Product Code): 00840331264470 (THYROIDSHIELD8-S8TSCHT-MD ). 71
Model
S8TSCMB
UDI
(Product Code): 00840331270617 (THYROIDSHIELDM8-S8TSCMB-LG ). 72
Model
S8TSCMN
UDI
(Product Code): 00840331264517 (THYROIDSHIELDM8-S8TSCMN-SM ). 73
Model
S8TSCMR
UDI
(Product Code): 00840331264524 (THYROIDSHIELDM8-S8TSCMR-LG ), 00840331264531 (THYROIDSHIELDM8-S8TSCMR-MD ), 00840331264548 (THYROIDSHIELDM8-S8TSCMR-SM ). 74
Model
S8TSCMS
UDI
(Product Code): 00840331264555 (THYROIDSHIELDM8-S8TSCMS-MD ), 00840331264562 (THYROIDSHIELDM8-S8TSCMS-SM ). 75
Model
S8TSCMT
UDI
(Product Code): 00840331264579 (THYROIDSHIELDM8-S8TSCMT-LG ), 00840331264586 (THYROIDSHIELDM8-S8TSCMT-MD ), 00840331264593 (THYROIDSHIELDM8-S8TSCMT-SM ). 76
Model
S8TSOBR
UDI
(Product Code): 00840331264807 (THYROIDSHIELDO8-S8TSOBR-LG ), 00840331264784 (THYROIDSHIELDO8-S8TSOBR-SM ). 77
Model
S8TSSBN
UDI
(Product Code): 00840331264883 (THYROIDSHIELD8-S8TSSBN-MD ). 78
Model
S8TSSBR
UDI
(Product Code): 00840331264906 (THYROIDSHIELD8-S8TSSBR-LG ), 00840331264913 (THYROIDSHIELD8-S8TSSBR-MD ), 00840331264920 (THYROIDSHIELD8-S8TSSBR-SM ). 79
Model
S8TSSBT
UDI
(Product Code): 00840331264944 (THYROIDSHIELD8-S8TSSBT-MD ). 80
Model
S8TSSHR
UDI
(Product Code): 00840331264999 (THYROIDSHIELD8-S8TSSHR-LG ), 00840331265002 (THYROIDSHIELD8-S8TSSHR-MD ), 00840331265019 (THYROIDSHIELD8-S8TSSHR-SM ). 81
Model
S8TSSHS
UDI
(Product Code): 00840331271164 (THYROIDSHIELD8-S8TSSHS-MD ). 82
Model
S8TSSHT
UDI
(Product Code): 00840331265033 (THYROIDSHIELD8-S8TSSHT-MD ). 83
Model
S8TSSMN
UDI
(Product Code): 00840331265064 (THYROIDSHIELDM8-S8TSSMN-MD ). 84
Model
S8TSSMR
UDI
(Product Code): 00840331265088 (THYROIDSHIELDM8-S8TSSMR-LG ), 00840331265095 (THYROIDSHIELDM8-S8TSSMR-MD ), 00840331265101 (THYROIDSHIELDM8-S8TSSMR-SM ). 85
Model
S8TSSMS
UDI
(Product Code): (THYROIDSHIELDM8-S8TSSMS-MD ). 86
Model
S8TSSMT
UDI
(Product Code): 00840331265118 (THYROIDSHIELDM8-S8TSSMT-LG ), 00840331265132 (THYROIDSHIELDM8-S8TSSMT-SM ). 87
Model
S8TSVBB
UDI
(Product Code): 00840331271799 (THYROIDSHIELD8-S8TSVBB-MD ). 88
Model
S8TSVBR
UDI
(Product Code): 00840331265187 (THYROIDSHIELD8-S8TSVBR-MD ). 89
Model
S8TSVHR
UDI
(Product Code): 00840331265279 (THYROIDSHIELD8-S8TSVHR-MD ), 00840331265286 (THYROIDSHIELD8-S8TSVHR-SM ). 90
Model
S8TSVMR
UDI
(Product Code): 00840331265392 (THYROIDSHIELDM8-S8TSVMR-MD ), 00840331265408 (THYROIDSHIELDM8-S8TSVMR-SM ). 91
Model
U8TSBBR
UDI
(Product Code): 00840331267853 (THYROIDSHIELDO8-U8TSBBR-SM ). 92
Model
U8TSBMN
UDI
(Product Code): 00840331267990 (THYROIDSHIELDOM8-U8TSBMN-MD ). 93
Model
U8TSBMR
UDI
(Product Code): 00840331268010 (THYROIDSHIELDOM8-U8TSBMR-LG ), 00840331268027 (THYROIDSHIELDOM8-U8TSBMR-MD ). 94
Model
U8TSCBN
UDI
(Product Code): 00840331268089 (THYROIDSHIELD8-U8TSCBN-MD ). 95
Model
U8TSCBR
UDI
(Product Code): 00840331268102 (THYROIDSHIELD8-U8TSCBR-LG ), 00840331268119 (THYROIDSHIELD8-U8TSCBR-MD ), 00840331268126 (THYROIDSHIELD8-U8TSCBR-SM ). 96
Model
U8TSCBT
UDI
(Product Code): 00840331268140 (THYROIDSHIELD8-U8TSCBT-MD ). 97
Model
U8TSCHR
UDI
(Product Code): 00840331268201 (THYROIDSHIELD8-U8TSCHR-MD ), 00840331268218 (THYROIDSHIELD8-U8TSCHR-SM ). 98
Model
U8TSCMR
UDI
(Product Code): 00840331268294 (THYROIDSHIELDM8-U8TSCMR-MD ), 00840331268300 (THYROIDSHIELDM8-U8TSCMR-SM ). 99
Model
U8TSCMT
UDI
(Product Code): 00840331268324 (THYROIDSHIELDM8-U8TSCMT-MD ), 00840331268331 (THYROIDSHIELDM8-U8TSCMT-SM ). 100
Model
U8TSOMR
UDI
(Product Code): 00840331268560 (THYROIDSHIELDOM8-U8TSOMR-MD ). 101
Model
U8TSSBN
UDI
(Product Code): 00840331268621 (THYROIDSHIELD8-U8TSSBN-MD ). 102
Model
U8TSSBR
UDI
(Product Code): 00840331268652 (THYROIDSHIELD8-U8TSSBR-MD ). 103
Model
U8TSSHN
UDI
(Product Code): 00840331268713 (THYROIDSHIELD8-U8TSSHN-MD ). 104
Model
U8TSSHR
UDI
(Product Code): 00840331268737 (THYROIDSHIELD8-U8TSSHR-LG ), 00840331268744 (THYROIDSHIELD8-U8TSSHR-MD ). 105
Model
U8TSSMR
UDI
(Product Code): 00840331268829 (THYROIDSHIELDM8-U8TSSMR-LG ), 00840331268836 (THYROIDSHIELDM8-U8TSSMR-MD ), 00840331268843 (THYROIDSHIELDM8-U8TSSMR-SM ). 106
Model
U8TSSMS
UDI
(Product Code): None (THYROIDSHIELDM8-U8TSSMS-SM ). 107
Model
U8TSSMT
UDI
(Product Code): 00840331268867 (THYROIDSHIELDM8-U8TSSMT-MD ), 00840331268874 (THYROIDSHIELDM8-U8TSSMT-SM ). 108
Model
U8TSVMR
UDI
(Product Code): 00840331269130 (THYROIDSHIELDM8-U8TSVMR-MD ), 00840331269147 (THYROIDSHIELDM8-U8TSVMR-SM )

What the firm is doing

Burlington Medical notified consignees on about 02/11/2026 via "URGENT - FIELD SAFETY NOTICE (FSN)" letter. Consignees were instructed to ensure all users of the specific Burlington Medical radiation protection garments made aware of this Recall Notice, review inventory for affected units, arrange for the return of those affected units for proper disposal, and complete and return the Recall Response Form. Consignees were also instructed to notify appropriate individuals within your organization and to any organization where the potentially affected devices were transferred or sold.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

More Class II recalls