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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Burlington Medical protective sleeves are medical device components used in clinical settings to provide protective coverage. They are distributed globally to hospitals and health systems.
Attenuation degradation over time reduces the device’s lifespan and could affect performance in medical procedures.
This recall is not described as part of a broader industry pattern.
Healthcare facilities may need to replace affected sleeves earlier than planned, potentially affecting inventory and procedures until replacements are secured.
Labels or packaging should include model numbers and UDI codes as shown in the recall.
4-8 weeks for refunds or replacements once authorized by the manufacturer and supplier.
Maintain copies of purchase receipts, model numbers, packaging labels, and all correspondence with Burlington Medical or distributors.
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
No injuries or incidents have been reported.
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