Skip to content

EURO recallZ-1757-2026 · Burlington Medical, LLC · initiated Feb 11, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Burlington Medical, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for attenuation degradation over time, decreasing the lifespan.

FDA root cause category: Process change control

What the company is doing

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.

Recall details

Recall number
Z-1757-2026
Status
Open, Classified
Initiated by the company
Feb 11, 2026
Posted by the FDA
Apr 2, 2026
Recalling firm
Burlington Medical, LLC
Quantity
5,198 units
Product code
IWO
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.

Product description

Burlington Medical, Wrap Aprons.

Code information (models, lots, serial numbers)

Show the full code information (13k characters)

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).

Devices named in this recall

123 devices in the FDA device registry whose identifier appears in the recall's code information; the 100 most reported are shown.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 98415).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page