Burlington Medical, LLC recalls Burlington Medical, Wrap 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: C8EURO; UDI-DI (Product Code): 00840331297683 (WRAPC8-C8EURO-LF ), 00840331297683 (WRAPC8-C8EURO-LM ), 00840331297683 (WRAPC8-C8EURO-MF ), 00840331297683 (WRAPC8-C8EURO-MM ), 00840331297683 (WRAPC8-C8EURO-SF ), 00840331297683 (WRAPC8-C8EURO-SM ), 00840331297683 (WRAPC8-C8EURO-XLM ), 00840331297683 (WRAPT18-C8EURO-LF ), 00840331297683 (WRAPT18-C8EURO-LM ), 00840331297683 (WRAPT18-C8EURO-MM ), 00840331297683 (WRAPT18-C8EURO-PLUS ), 00840331297683 (WRAPT18-C8EURO-SM ). 2. Model Number: C8F111; UDI-DI (Product Code): 00840331297690 (WRAPT18-C8F111-MM). 3. Model Number: R8EURO; UDI-DI (Product Code): 00840331258721 (WRAPC18-R8EURO-2XF ), 00840331258738 (WRAPC18-R8EURO-2XM ), 00840331258745 (WRAPC18-R8EURO-3XF ), 00840331258752 (WRAPC18-R8EURO-3XM ), 00840331258769 (WRAPC8-R8EURO-LF ), 00840331258776 (WRAPC8-R8EURO-LM ), 00840331258783 (WRAPC8-R8EURO-MF ), 00840331258790 (WRAPC8-R8EURO-MM ), 00840331258806 (WRAPC8-R8EURO-PLUS ), 00840331258813 (WRAPC8-R8EURO-SF ), 00840331258820 (WRAPC8-R8EURO-SM ), 00840331258837 (WRAPC8-R8EURO-XLF ), 00840331258844 (WRAPC8-R8EURO-XLM ), 00840331258851 (WRAPC8-R8EURO-XSF ), 00840331258868 (WRAPC8-R8EURO-XSM ), 00840331258769 (WRAPS8-R8EURO-LF ), 00840331258776 (WRAPS8-R8EURO-LM ), 00840331258783 (WRAPS8-R8EURO-MF ), 00840331258790 (WRAPS8-R8EURO-MM ), 00840331258813 (WRAPS8-R8EURO-SF ), 00840331258820 (WRAPS8-R8EURO-SM ), 00840331258837 (WRAPS8-R8EURO-XLF ), 00840331258844 (WRAPS8-R8EURO-XLM ), 00840331270044 (WRAPT18-R8EURO-LF ), 00840331270051 (WRAPT18-R8EURO-LM ), 00840331270051 (WRAPT18-R8EURO-MF ), 00840331270051 (WRAPT18-R8EURO-MM ), 00840331270044 (WRAPT18-R8EURO-PLUS ), 00840331270044 (WRAPT18-R8EURO-SF ), 00840331270051 (WRAPT18-R8EURO-SM ), 00840331270044 (WRAPT18-R8EURO-XLF ), 00840331270051 (WRAPT18-R8EURO-XLM ), 00840331270051 (WRAPT18-R8EURO-XSM ), 00840331270044 (WRAPT28-R8EURO-2XF ), 00840331270051 (WRAPT28-R8EURO-2XM ), 00840331270044 (WRAPT28-R8EURO-3XF ), 00840331270051 (WRAPT28-R8EURO-3XM ), 00840331270044 (WRAPT28-R8EURO-4XF ), 00840331270051 (WRAPT28-R8EURO-4XM ), 00840331270044 (WRAPT28-R8EURO-5XF ), 00840331270051 (WRAPT28-R8EURO-5XM ), 00840331270044 (WRAPT38-R8EURO-6XF ), 00840331270051 (WRAPT38-R8EURO-6XM ), 00840331270044 (WRAPT38-R8EURO-7XF ), 00840331270051 (WRAPT38-R8EURO-7XM ), 00840331270044 (WRAPT38-R8EURO-8XF ), 00840331270051 (WRAPT38-R8EURO-8XM ), None (IWRAPC8-R8EURO-LFR ), None (IWRAPC8-R8EURO-MFR ), None (IWRAPC8-R8EURO-PLUSL ), None (IWRAPC8-R8EURO-SFS ). 4. Model Number: R8F111; UDI-DI (Product Code): 00840331259049 (WRAPC18-R8F111-2XF ), 00840331259056 (WRAPC18-R8F111-2XM ), 00840331259063 (WRAPC18-R8F111-3XF ), 00840331259087 (WRAPC8-R8F111-LF ), 00840331259094 (WRAPC8-R8F111-LM ), 00840331259100 (WRAPC8-R8F111-MF ), 00840331259117 (WRAPC8-R8F111-MM ), 00840331259124 (WRAPC8-R8F111-PLUS ), 00840331259131 (WRAPC8-R8F111-SF ), 00840331259148 (WRAPC8-R8F111-SM ), 00840331259155 (WRAPC8-R8F111-XLF ), 00840331259162 (WRAPC8-R8F111-XLM ), 00840331270105 (WRAPT18-R8F111-LF ), 00840331270112 (WRAPT18-R8F111-LM ), 00840331270105 (WRAPT18-R8F111-MF ), 00840331270112 (WRAPT18-R8F111-MM ), 00840331270105 (WRAPT18-R8F111-PLUS ), 00840331270105 (WRAPT18-R8F111-SF ), 00840331270112 (WRAPT18-R8F111-SM ), 00840331270105 (WRAPT18-R8F111-XLF ), 00840331270112 (WRAPT18-R8F111-XLM ), 00840331270112 (WRAPT18-R8F111-XSM ), 00840331270105 (WRAPT28-R8F111-2XF ), 00840331270112 (WRAPT28-R8F111-2XM ), 00840331270105 (WRAPT28-R8F111-3XF ), 00840331270112 (WRAPT28-R8F111-3XM ), 00840331270105 (WRAPT28-R8F111-4XF ), 00840331270112 (WRAPT28-R8F111-4XM ), 00840331270105 (WRAPT28-R8F111-5XF ), 00840331270112 (WRAPT28-R8F111-5XM ), 00840331270105 (WRAPT38-R8F111-6XF ), 00840331270112 (WRAPT38-R8F111-6XM ), 00840331270112 (WRAPT38-R8F111-8XM ), None (IWRAPC8-R8F111-MML ). 5. Model Number: R8F112; UDI-DI (Product Code): 00840331259209 (WRAPC18-R8F112-2XF ), 00840331259223 (WRAPC18-R8F112-3XF ), 00840331259247 (WRAPC8-R8F112-LF ), 00840331259254 (WRAPC8-R8F112-LM ), 00840331259261 (WRAPC8-R8F112-MF ), 00840331259278 (WRAPC8-R8F112-MM ), 00840331259292 (WRAPC8-R8F112-SF ), 00840331259308 (WRAPC8-R8F112-SM ), 00840331259315 (WRAPC8-R8F112-XLF ), 00840331259322 (WRAPC8-R8F112-XLM ), 00840331259339 (WRAPC8-R8F112-XSF ), 00840331259346 (WRAPC8-R8F112-XSM ), 00840331270167 (WRAPT18-R8F112-LF ), 00840331270174 (WRAPT18-R8F112-LM ), 00840331270167 (WRAPT18-R8F112-MF ), 00840331270174 (WRAPT18-R8F112-MM ), 00840331270167 (WRAPT18-R8F112-PLUS ), 00840331270167 (WRAPT18-R8F112-SF ), 00840331270174 (WRAPT18-R8F112-SM ), 00840331270167 (WRAPT18-R8F112-XLF ), 00840331270174 (WRAPT18-R8F112-XLM ), 00840331270174 (WRAPT18-R8F112-XSM ), 00840331270174 (WRAPT28-R8F112-2XM ), 00840331270167 (WRAPT28-R8F112-3XF ), 00840331270174 (WRAPT28-R8F112-4XM ), 00840331270167 (WRAPT28-R8F112-5XF ), 00840331270105 (WRAPT38-R8F112-6XF ), 00840331270105 (WRAPT38-R8F112-7XF ), 00840331270112 (WRAPT38-R8F112-7XM ), None (IWRAPC8-R8F112-2XML ), None (IWRAPC8-R8F112-LFR ), None (IWRAPC8-R8F112-LMR ), None (IWRAPC8-R8F112-MFR ), None (IWRAPC8-R8F112-MFS ), None (IWRAPC8-R8F112-MMR ), None (IWRAPC8-R8F112-MMS ), None (IWRAPC8-R8F112-PLUSL ), None (IWRAPC8-R8F112-PLUSR ), None (IWRAPC8-R8F112-SFS ), None (IWRAPC8-R8F112-SMS ), None (IWRAPC8-R8F112-XLFL ), None (IWRAPC8-R8F112-XLML ), None (IWRAPC8-R8F112-XSFS ), None (IWRAPC8-R8F112-XSMS ), None (IWRAPC8-R8F112-MML ). 6. Model Number: R8P600; UDI-DI (Product Code): 00197513001126 (PWRAPC8-R8P600-MD ). 7. Model Number: R8W113; UDI-DI (Product Code): 00197513007906 (WRAPC18-R8W113-2XF ), 00197513007890 (WRAPC18-R8W113-2XM ), 00197513007043 (WRAPC8-R8W113-MF ), 00197513007036 (WRAPC8-R8W113-MM ). 8. Model Number: R8W114; UDI-DI (Product Code): 00197513010210 (WRAPC18-R8W114-2XF ), 00197513010203 (WRAPC18-R8W114-2XM ), 00197513009351 (WRAPC8-R8W114-MF ), 00197513009344 (WRAPC8-R8W114-MM ). 9. Model Number: S8EURO; UDI-DI (Product Code): 00840331262476 (WRAPC18-S8EURO-2XF ), 00840331262483 (WRAPC18-S8EURO-2XM ), 00840331262490 (WRAPC18-S8EURO-3XF ), 00840331262506 (WRAPC18-S8EURO-3XM ), 00840331262513 (WRAPC8-S8EURO-LF ), 00840331262520 (WRAPC8-S8EURO-LM ), 00840331262537 (WRAPC8-S8EURO-MF ), 00840331262544 (WRAPC8-S8EURO-MM ), 00840331262551 (WRAPC8-S8EURO-PLUS ), 00840331262568 (WRAPC8-S8EURO-SF ), 00840331262575 (WRAPC8-S8EURO-SM ), 00840331262582 (WRAPC8-S8EURO-XLF ), 00840331262599 (WRAPC8-S8EURO-XLM ), 00840331262605 (WRAPC8-S8EURO-XSF ), 00840331262612 (WRAPC8-S8EURO-XSM ), 00840331262513 (WRAPS8-S8EURO-LF ), 00840331262520 (WRAPS8-S8EURO-LM ), 00840331262537 (WRAPS8-S8EURO-MF ), 00840331262544 (WRAPS8-S8EURO-MM ), 00840331262568 (WRAPS8-S8EURO-SF ), 00840331262575 (WRAPS8-S8EURO-SM ), 00840331262599 (WRAPS8-S8EURO-XLM ), 00840331270068 (WRAPT18-S8EURO-LF ), 00840331270075 (WRAPT18-S8EURO-LM ), 00840331270068 (WRAPT18-S8EURO-MF ), 00840331270075 (WRAPT18-S8EURO-MM ), 00840331270068 (WRAPT18-S8EURO-PLUS ), 00840331270068 (WRAPT18-S8EURO-SF ), 00840331270075 (WRAPT18-S8EURO-SM ), 00840331270068 (WRAPT18-S8EURO-XLF ), 00840331270075 (WRAPT18-S8EURO-XLM ), 00840331270068 (WRAPT18-S8EURO-XSF ), 00840331270075 (WRAPT18-S8EURO-XSM ), 00840331270068 (WRAPT28-S8EURO-2XF ), 00840331270075 (WRAPT28-S8EURO-2XM ), 00840331270068 (WRAPT28-S8EURO-3XF ), 00840331270075 (WRAPT28-S8EURO-3XM ), 00840331270068 (WRAPT28-S8EURO-4XF ), 00840331270075 (WRAPT28-S8EURO-4XM ), 00840331270068 (WRAPT28-S8EURO-5XF ), 00840331270075 (WRAPT28-S8EURO-5XM ), 00840331270068 (WRAPT38-S8EURO-6XF ), 00840331270075 (WRAPT38-S8EURO-6XM ), 00840331270068 (WRAPT38-S8EURO-7XF ), 00840331270075 (WRAPT38-S8EURO-7XM ), 00840331270068 (WRAPT38-S8EURO-8XF ), 00840331270075 (WRAPT38-S8EURO-8XM ). 10. Model Number: S8F111; UDI-DI (Product Code): 00840331262797 (WRAPC18-S8F111-2XF ), 00840331262803 (WRAPC18-S8F111-2XM ), 00840331262834 (WRAPC8-S8F111-LF ), 00840331262841 (WRAPC8-S8F111-LM ), 00840331262841 (WRAPC8-S8F111-MF ), 00840331262865 (WRAPC8-S8F111-MM ), 00840331262872 (WRAPC8-S8F111-PLUS ), 00840331262889 (WRAPC8-S8F111-SF ), 00840331262896 (WRAPC8-S8F111-SM ), 00840331262902 (WRAPC8-S8F111-XLF ), 00840331262919 (WRAPC8-S8F111-XLM ), 00840331270129 (WRAPT18-S8F111-LF ), 00840331270136 (WRAPT18-S8F111-LM ), 00840331270129 (WRAPT18-S8F111-MF ), 00840331270136 (WRAPT18-S8F111-MM ), 00840331270129 (WRAPT18-S8F111-PLUS ), 00840331270129 (WRAPT18-S8F111-SF ), 00840331270136 (WRAPT18-S8F111-SM ), 00840331270129 (WRAPT18-S8F111-XLF ), 00840331270136 (WRAPT18-S8F111-XLM ), 00840331270136 (WRAPT18-S8F111-XSM ), 00840331270129 (WRAPT28-S8F111-2XF ), 00840331270136 (WRAPT28-S8F111-2XM ), 00840331270129 (WRAPT28-S8F111-3XF ), 00840331270136 (WRAPT28-S8F111-3XM ), 00840331270129 (WRAPT28-S8F111-4XF ), 00840331270136 (WRAPT28-S8F111-4XM ), 00840331270129 (WRAPT28-S8F111-5XF ), 00840331270136 (WRAPT28-S8F111-5XM ), 00840331270129 (WRAPT38-S8F111-6XF ), 00840331270136 (WRAPT38-S8F111-6XM ), 00840331270129 (WRAPT38-S8F111-8XF ), 00840331270136 (WRAPT38-S8F111-8XM ). 11. Model Number: S8F112; UDI-DI (Product Code): 00840331262964 (WRAPC18-S8F112-2XM ), 00840331262995 (WRAPC8-S8F112-LF ), 00840331263008 (WRAPC8-S8F112-LM ), 00840331263015 (WRAPC8-S8F112-MF ), 00840331263022 (WRAPC8-S8F112-MM ), 00840331263046 (WRAPC8-S8F112-SF ), 00840331263053 (WRAPC8-S8F112-SM ), 00840331263077 (WRAPC8-S8F112-XLM ), 00840331270181 (WRAPT18-S8F112-LF ), 00840331270198 (WRAPT18-S8F112-LM ), 00840331270181 (WRAPT18-S8F112-MF ), 00840331270198 (WRAPT18-S8F112-MM ), 00840331270181 (WRAPT18-S8F112-PLUS ), 00840331270198 (WRAPT18-S8F112-SM ), 00840331270181 (WRAPT18-S8F112-XLF ), 00840331270198 (WRAPT18-S8F112-XLM ), 00840331270181 (WRAPT28-S8F112-2XF ), 00840331270198 (WRAPT28-S8F112-2XM ), 00840331270198 (WRAPT28-S8F112-3XM ), 00840331270181 (WRAPT28-S8F112-4XF ), 00840331270198 (WRAPT28-S8F112-5XM ). 12. Model Number: S8W113; UDI-DI (Product Code): 00197513000594 (WRAPT28-S8W113-3XF ). 13. Model Number: U8EURO; UDI-DI (Product Code): 00840331266207 (WRAPC18-U8EURO-2XF ), 00840331266214 (WRAPC18-U8EURO-2XM ), 00840331266245 (WRAPC8-U8EURO-LF ), 00840331266252 (WRAPC8-U8EURO-LM ), 00840331266269 (WRAPC8-U8EURO-MF ), 00840331266269 (WRAPC8-U8EURO-MM ), 00840331266283 (WRAPC8-U8EURO-PLUS ), 00840331266306 (WRAPC8-U8EURO-SM ), 00840331266313 (WRAPC8-U8EURO-XLF ), 00840331266320 (WRAPC8-U8EURO-XLM ), 00840331266337 (WRAPC8-U8EURO-XSF ), 00840331266344 (WRAPC8-U8EURO-XSM ), 00840331266245 (WRAPS8-U8EURO-LF ), 00840331266252 (WRAPS8-U8EURO-LM ), 00840331266269 (WRAPS8-U8EURO-MF ), 00840331266276 (WRAPS8-U8EURO-MM ), 00840331266306 (WRAPS8-U8EURO-SM ), 00840331266320 (WRAPS8-U8EURO-XLM ), 00840331270082 (WRAPT18-U8EURO-LF ), 00840331270099 (WRAPT18-U8EURO-LM ), 00840331270082 (WRAPT18-U8EURO-MF ), 00840331270099 (WRAPT18-U8EURO-MM ), 00840331270082 (WRAPT18-U8EURO-PLUS ), 00840331270082 (WRAPT18-U8EURO-SF ), 00840331270099 (WRAPT18-U8EURO-SM ), 00840331270082 (WRAPT18-U8EURO-XLF ), 00840331270099 (WRAPT18-U8EURO-XLM ), 00840331270099 (WRAPT18-U8EURO-XSM ), 00840331270082 (WRAPT28-U8EURO-2XF ), 00840331270099 (WRAPT28-U8EURO-2XM ), 00840331270082 (WRAPT28-U8EURO-3XF ), 00840331270099 (WRAPT28-U8EURO-3XM ), 00840331270082 (WRAPT28-U8EURO-4XF ), 00840331270099 (WRAPT28-U8EURO-4XM ), 00840331270082 (WRAPT28-U8EURO-5XF ), 00840331270099 (WRAPT28-U8EURO-5XM ), 00840331270082 (WRAPT38-U8EURO-6XF ), 00840331270099 (WRAPT38-U8EURO-6XM ), 00840331270082 (WRAPT38-U8EURO-7XF ), 00840331270099 (WRAPT38-U8EURO-7XM ), 00840331270099 (WRAPT38-U8EURO-8XM ). 14. Model Number: U8F111; UDI-DI (Product Code): 00840331266566 (WRAPC8-U8F111-LF ), 00840331266573 (WRAPC8-U8F111-LM ), 00840331266580 (WRAPC8-U8F111-MF ), 00840331266597 (WRAPC8-U8F111-MM ), 00840331266603 (WRAPC8-U8F111-PLUS ), 00840331266634 (WRAPC8-U8F111-XLF ), 00840331266641 (WRAPC8-U8F111-XLM ), 00840331270143 (WRAPT18-U8F111-LF ), 00840331270150 (WRAPT18-U8F111-LM ), 00840331270143 (WRAPT18-U8F111-MF ), 00840331270150 (WRAPT18-U8F111-MM ), 00840331270143 (WRAPT18-U8F111-PLUS ), 00840331270150 (WRAPT18-U8F111-SM ), 00840331270143 (WRAPT18-U8F111-XLF ), 00840331270150 (WRAPT18-U8F111-XLM ), 00840331270143 (WRAPT28-U8F111-2XF ), 00840331270150 (WRAPT28-U8F111-2XM ), 00840331270150 (WRAPT28-U8F111-3XM ), 00840331270143 (WRAPT28-U8F111-4XF ), 00840331270150 (WRAPT28-U8F111-4XM ), 00840331270143 (WRAPT28-U8F111-5XF ), 00840331270143 (WRAPT38-U8F111-6XF ), 00840331270150 (WRAPT38-U8F111-6XM ), 00840331270143 (WRAPT38-U8F111-7XF ), None (IWRAPC8-U8F111-2XMR ), None (IWRAPC8-U8F111-LMR ), None (IWRAPC8-U8F111-MMR ), None (IWRAPC8-U8F111-SMR ), None (IWRAPC8-U8F111-XLMR ). 15. Model Number: U8F112; UDI-DI (Product Code): 00840331266740 (WRAPC8-U8F112-MF ), 00840331270211 (WRAPT18-U8F112-MM ), 00840331270211 (WRAPT18-U8F112-XLM ), 00840331270211 (WRAPT28-U8F112-4XM ), 00840331270204 (WRAPT28-U8F112-5XF ), None (IWRAPC8-U8F112-2XMR ), None (IWRAPC8-U8F112-LMR ), None (IWRAPC8-U8F112-MMR ), None (IWRAPC8-U8F112-SMR ), None (IWRAPC8-U8F112-XLMR ), None (IWRAPC8-U8F112-XLMXL ). 16. Model Number: U8W113; UDI-DI (Product Code): 00197513000587 (WRAPT28-U8W113-3XF ). 17. Model Number: R8EURO; UDI-DI (Product Code): None (IWRAPC8-R8EURO-LMR).