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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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,
The devices may experience attenuation degradation over time. This could shorten the device lifespan and affect performance.
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. The recall notification will be sent by letter.
Phone: Unknown. Website: Unknown. Hours: Unknown.
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