Burlington Medical recalled 51 Blocker devices sold worldwide after a recall notice. The devices may degrade attenuation over time, shortening their lifespan. Stop using the devices immediately and follow the manufacturer’s recall instructions. Contact Burlington Medical, LLC or your healthcare provider for guidance. Distribution is worldwide.
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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Blockers are attenuation devices produced by Burlington Medical and used in certain medical procedures where attenuation control is required.
Over time the attenuation material may degrade, reducing device lifespan and potentially compromising performance.
This recall is not described as part of a broader industry pattern.
Clinicians may need to replace affected devices, potentially delaying procedures and increasing administrative work for recalls.
UDI-DI on the device label and packaging; recall notice letters from Burlington Medical.
Refunds or replacements typically take 4-8 weeks after processing.
Keep the recall letter, take photos of the device label, saving the model and UDI-DI, and maintain a log of communications.
Models: R8BLOCKER1, R8BLOCKER2, R8BLOCKER3, R8BLOCKER4, R8BLOCKER5, R8BLOCKER6, S8BLOCKER1, S8BLOCKER2, S8BLOCKER3, U8BLOCKER1. UDI-DI codes listed with each model: BLOCKER8-R8BLOCKER1, BLOCKER8-R8BLOCKER2, BLOCKER8-R8BLOCKER3, BLOCKER8-R8BLOCKER4, BLOCKER8-R8BLOCKER5, BLOCKER8-R8BLOCKER6, BLOCKER8-S8BLOCKER1, BLOCKER8-S8BLOCKER2, BLOCKER8-S8BLOCKER3, BLOCKER8-U8BLOCKER1. Material: Xenolite 800 attenuation material. Manufactured with this material from 2025-01-16 to 2026-01-21. Distribution: Worldwide including US, Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Peru,
No injuries or incidents have been reported.
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