Burlington Medical, LLC recalled 103 leg wrap devices distributed worldwide through multiple retailers. The recall cites attenuation degradation over time that could shorten the devices' lifespan. Healthcare providers and patients should stop using them immediately and follow the manufacturer's recall instructions.
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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Leg wraps used for compression therapy, typically prescribed for edema or venous disease. They help manage swelling and improve circulation in the legs.
Attenuation degradation over time can reduce device lifespan and performance, potentially compromising sustained compression.
This recall is not part of a broader industry pattern.
Consumers may need to replace the device sooner than expected, incurring cost and coordinating with healthcare providers.
Recall notice and model/UDI details are on the FDA enforcement page. Look for the recall Z-1761-2026 page.
Not specified in the recall; monitor FDA updates and follow manufacturer communications.
Keep the recall letter, model numbers, dates, and all communications with the manufacturer. Photograph the device and store all correspondence.
103 units recalled. Distribution: Worldwide, including US nationwide and international sites in Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam. Models affected include R8LGW1, R8LGW2, R8LGW3, S8LGW1, S8LGW2, S8LGW3, S8LGW4, U8LGW1, LGW8SET-U8LGW2, U8LGW4, LGW8SET-U8LGW4. All serial numbers manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026 are affected. UDI-DI codes: 00840331272079 (LGW8SET-R8LGW1) through 00840331272147 (LGW8SET-U8LGW4). Price not disclosed.
No injuries or incidents have been reported.
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