HALF APRON recallZ-1762-2026 · Burlington Medical, LLC · initiated Feb 11, 2026
Open, Classified
Is my device affected?
- 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.
- 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.
- 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-1762-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 11, 2026
- Posted by the FDA
- Apr 2, 2026
- Recalling firm
- Burlington Medical, LLC
- Quantity
- 402 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, Half Aprons.
Code information (models, lots, serial numbers)
Show the full code information (3k 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: R8HALF1B; UDI-DI (Product Code): 00840331272291 (HALF18-R8HALF1B). 2. Model Number: R8HALF1H; UDI-DI (Product Code): 00840331272314 (HALF18-R8HALF1H). 3. Model Number: R8HALF2B; UDI-DI (Product Code): 00840331272338 (HALF28-R8HALF2B). 4. Model Number: R8HALF2H; UDI-DI (Product Code): 00840331272345 (HALF28-R8HALF2H). 5. Model Number: R8HALF3B; UDI-DI (Product Code): 00840331272352 (HALF38-R8HALF3B). 6. Model Number: R8HALF3H; UDI-DI (Product Code): 00840331272369 (HALF38-R8HALF3H). 7. Model Number: R8HALF4B; UDI-DI (Product Code): 00840331272376 (HALF48-R8HALF4B). 8. Model Number: R8HALF4H; UDI-DI (Product Code): 00840331272383 (HALF48-R8HALF4H). 9. Model Number: R8HALF5B; UDI-DI (Product Code): 00840331272390 (HALF58-R8HALF5B). 10. Model Number: R8HALF5H; UDI-DI (Product Code): 00840331272406 (HALF58-R8HALF5H). 11. Model Number: R8HALF6B; UDI-DI (Product Code): 00840331272420 (HALF68-R8HALF6B). 12. Model Number: R8HALF6H; UDI-DI (Product Code): 00840331272352 (HALF68-R8HALF6H). 13. Model Number: R8HALFSETB; UDI-DI (Product Code): 00840331272413 (HALFSET8-R8HALFSETB). 14. Model Number: R8HALFSETH; UDI-DI (Product Code): 00840331272420 (HALFSET8-R8HALFSETH). 15. Model Number: S8HALF1H; UDI-DI (Product Code): 00840331272451 (HALF18-S8HALF1H). 16. Model Number: S8HALF2B; UDI-DI (Product Code): 00840331272475 (HALF28-S8HALF2B). 17. Model Number: S8HALF2H; UDI-DI (Product Code): 00840331272482 (HALF28-S8HALF2H). 18. Model Number: S8HALF3B; UDI-DI (Product Code): 00840331272499 (HALF38-S8HALF3B). 19. Model Number: S8HALF3H; UDI-DI (Product Code): 00840331272505 (HALF38-S8HALF3H). 20. Model Number: S8HALF4B; UDI-DI (Product Code): 00840331272512 (HALF48-S8HALF4B). 21. Model Number: S8HALF4H; UDI-DI (Product Code): 00840331272529 (HALF48-S8HALF4H). 22. Model Number: S8HALF5B; UDI-DI (Product Code): 00840331272536 (HALF58-S8HALF5B). 23. Model Number: S8HALF5H; UDI-DI (Product Code): 00840331272543 (HALF58-S8HALF5H). 24. Model Number: S8HALF6H; UDI-DI (Product Code): 00840331272499 (HALF68-S8HALF6H). 25. Model Number: S8HALFSETH; UDI-DI (Product Code): 00840331272567 (HALFSET8-S8HALFSETH). 26. Model Number: U8HALF3B; UDI-DI (Product Code): 00840331272635 (HALF38-U8HALF3B). 27. Model Number: U8HALF3H; UDI-DI (Product Code): 00840331272642 (HALF38-U8HALF3H). 28. Model Number: U8HALF4H; UDI-DI (Product Code): 00840331272666 (HALF48-U8HALF4H). 29. Model Number: U8HALF5H; UDI-DI (Product Code): 00840331272680 (HALF58-U8HALF5H). 30. Model Number: U8HALF6H; UDI-DI (Product Code): 00840331272635 (HALF68-U8HALF6H).
Devices named in this recall
26 devices in the FDA device registry whose identifier appears in the recall's code information.
- HALF APRON R8HALF1HBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON R8HALF3HBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON R8HALF4HBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON R8HALF5HBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON R8HALF6HBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON R8HALF1BBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON R8HALF2BBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON R8HALF3BBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON R8HALFS8TBBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON R8HALF4BBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON R8HALF5BBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON R8HALF6BBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON S8HALF3HBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON S8HALF4HBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON S8HALF5HBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON S8HALF6HBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON S8HALF1BBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON S8HALF2BBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON S8HALF3BBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON S8HALFS8TBBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON S8HALF4BBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON S8HALF6BBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON U8HALF6HBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON U8HALF1BBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON U8HALF3BBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON U8HALF4BBurlington Medical, LLC · Apron, Protective1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 98415).
- Z-1753-2026 · Open, ClassifiedBurlington Medical, Thyroid Shield.
- Z-1754-2026 · Open, ClassifiedBurlington Medical, Vest
- Z-1755-2026 · Open, ClassifiedBurlington Medical, Kilt
- Z-1756-2026 · Open, ClassifiedBurlington Medical, Frontal Aprons
- Z-1757-2026 · Open, ClassifiedBurlington Medical, Wrap Aprons.
- Z-1758-2026 · Open, ClassifiedBurlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.
- Z-1759-2026 · Open, ClassifiedBurlington Medical, Protective Sleeves.
- Z-1760-2026 · Open, ClassifiedBurlington Medical, Caps.
- Z-1761-2026 · Open, ClassifiedBurlington Medical, Leg Wraps.
- Z-1763-2026 · Open, ClassifiedBurlington Medical, Demi Half Aprons.
- Z-1764-2026 · Open, ClassifiedBurlington Medical, Blockers.
- Z-1765-2026 · Open, ClassifiedBurlington Medical, Kilt Blockers.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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