Burlington Medical, LLC: Burlington Medical, Kilt

Recall number

Z-1755-2026

Recalling firm

Burlington Medical, LLC

Product

Burlington Medical, Kilt

Status

Open, Classified

Initiated

2026-02-11

Posted

2026-04-02

Terminated

not on file

Reason

Potential for attenuation degradation over time, decreasing the lifespan.

Root cause

Process change control

Action

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

Quantity

15,216 units

Distribution

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.

Lot, serial or model codes

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 ).

510(k) numbers

not on file

PMA numbers

not on file

Product code

IWO

Firm FEI

1000120804

Firm city

Newport News

Firm state

VA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy