Burlington Medical recalled 1,129 protective sleeves worldwide after determining attenuation degradation over time. The sleeves were manufactured with Xenolite 800 attenuation material between 2025-01-16 and 2026-01-21. The recall affects products distributed in the United States and internationally. Providers and patients should stop using the sleeve and follow recall instructions from the maker.
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: R8SL; R8SL3; SL8-R8SL; SL38-R8SL3-LG; SL38-R8SL3-MD; SL38-R8SL3-SM; SL38-R8SL3-XL; SL38-R8SL3-XS; S8SL; SL8-S8SL; SL38-S8SL3-LG; SL38-S8SL3-MD; SL38-S8SL3-SM; SL38-S8SL3-XL; SL38-S8SL3-XS; U8SL; SL8-U8SL; SL38-U8SL3-LG; SL38-U8SL3-MD; SL38-U8SL3-SM; SL38-U8SL3-XL; SL38-U8SL3-XS Sold at: Worldwide distribution, including the United States and Canada, plus Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, Vietnam When sold: Manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026 Price: Unknown Quantity: 1
The recall cites attenuation degradation over time, which reduces the device’s lifespan. The issue could compromise performance of the protective sleeves used in medical settings.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow the recall instructions provided by the manufacturer. 3. Contact Burlington Medical, LLC or your healthcare provider for instructions. 4. Refund or replacement details are not specified in the recall notice. Check the FDA recall page for the latest instructions.
Recall URL: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1759-2026 Phone: Unknown Website: Unknown Hours: Unknown
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