Burlington Medical recalled 1,489 BAT Coverage units worldwide on 2026-02-11 after a design-related issue was identified. The recall targets attenuation material used in the device. The defect could affect the lifespan of the shielding. Healthcare providers and patients should stop using the device and follow manufacturer instructions. The recall is active as of 2026-04-08.
Potential for attenuation degradation over time, decreasing the lifespan.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Burlington Medical, LLC or your healthcare provider for instructions. Notification method: Letter
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Model Numbers: BATB and BATH. UDI-DI: 00197513011941 (BATC18-R8BATB-2XF, BATC18-R8BATB-3XF); 00197513011941 (BATC8-R8BATB-LF, BATC8-R8BATB-LM, BATC8-R8BATB-MF, BATC8-R8BATB-MM, BATC8-R8BATB-PLUS, BATC8-R8BATB-SF, BATC8-R8BATB-XLF, BATC8-R8BATB-XLM, BATC8-R8BATB-XSF). Model Number: BATH. UDI-DI: 00197513011934 (BATC18-R8BATH-2XF, BATC18-R8BATH-2XM, BATC18-R8BATH-3XF, BATC18-R8BATH-3XM); 00197513011934 (BATC8-R8BATH-LF, BATC8-R8BATH-LM, BATC8-R8BATH-MF, BATC8-R8BATH-MM). Distribution: Worldwide, including nationwide in the US and Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, at
The device uses Xenolite 800 attenuation material. Over time, the material may degrade, reducing the shielding lifespan and potentially compromising performance during procedures where attenuation is required.
No injuries or incidents have been reported.
1. Stop using the product. 2. Review recall instructions from the manufacturer. 3. Contact Burlington Medical, LLC or your healthcare provider for further instructions. 4. Follow guidance on replacement or refund as provided by the recall.
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1758-2026. Manufacturer contact details were not provided in the notice.
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