Burlington Medical, LLC recalls Burlington Medical, Frontal Aprons

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: 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 ).