medical MODERATE Updated 2026-04-08

Burlington Medical, LLC recalls Burlington Medical, Kilt

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Recalled Product

Burlington Medical, Kilt

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Hazard / Issue

Potential for attenuation degradation over time, decreasing the lifespan.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: 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 ).

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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