DHALF recallZ-1763-2026 · 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-1763-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 11, 2026
- Posted by the FDA
- Apr 2, 2026
- Recalling firm
- Burlington Medical, LLC
- Quantity
- 29 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, Demi Half Aprons.
Code information (models, lots, serial numbers)
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8DHALFR; UDI-DI (Product Code): 00197513001485 (DHALF8-R8DHALFR-L), 00197513001478 (DHALF8-R8DHALFR-M), 00197513001461 (DHALF8-R8DHALFR-S), 00197513001492 (DHALF8-R8DHALFR-XL), 00197513001607 (DHALFSET8-R8DHALFR-SET).
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- DHALF R8DHALFR-SBurlington Medical, LLC · Apron, Protective1 recall0 reports
- DHALF R8DHALFR-MBurlington Medical, LLC · Apron, Protective1 recall0 reports
- DHALF R8DHALFR-LBurlington Medical, LLC · Apron, Protective1 recall0 reports
- DHALF R8DHALFR-XLBurlington Medical, LLC · Apron, Protective1 recall0 reports
- DHALF R8DHALFR-SETBurlington 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-1762-2026 · Open, ClassifiedBurlington Medical, 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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