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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BAT Coverage is a radiation attenuation device designed to protect the breast, axilla, and thyroid areas during procedures.
Attenuation material may degrade over time, potentially reducing shielding effectiveness and shortening device lifespan.
This recall is not part of a broader industry pattern.
Affects 1,489 units worldwide with potential reduced protection during radiologic exams; users should stop use and await replacement or refund guidance.
On device labeling, packaging and the UDI printed on the product; FDA recall page linked above.
No specific timeline given; recall processes typically take 4-8 weeks after processing.
Keep recall letter, purchase records, model numbers, UDI codes, and all correspondence with the manufacturer
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
No injuries or incidents have been reported.
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