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Burlington Medical, Kilt

Lot codes and dates: All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1
Model NumberC8K303
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 NumberR8K303
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 NumberR8KILT
UDI-DI (Product Code)
83 of 83 codes
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 )
Model NumberR8S302
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 NumberR8SKIRT
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 NumberS8K303
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 NumberS8KILT
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 NumberS8S302
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 NumberS8SKIRT
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 NumberU8K303
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 NumberU8KILT
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 NumberU8S302
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 )
Amount recalled: 15,216 units

This recall covers 13 products

The agency filed one notice per product. You are reading one of them; the other 12 are below.

Where it was sold

Nationwide

Why it was recalled

Potential for attenuation degradation over time, decreasing the lifespan.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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