Burlington Medical recalled 94 Kilt Blockers sold worldwide through distributors and healthcare providers. The devices may attenuate over time, shortening their lifespan. Stop using immediately and contact Burlington Medical or your healthcare provider for 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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Kilt Blockers are medical devices produced by Burlington Medical for use in clinical settings. This recall affects devices manufactured with Xenolite 800 attenuation material during a defined period and distributed worldwide.
Attenuation degradation over time may shorten device lifespan and impact performance. This creates a potential safety concern in clinical use.
This recall is not described as part of a broader industry pattern.
Affecting 94 units, the recall could require clinicians to replace or service affected devices. No injuries have been reported yet. Consumers should stop using affected devices immediately.
Consult the FDA enforcement page for recall Z-1765-2026 and Burlington Medical recall communications.
Recall events began on 2026-02-11; resolution timelines are not specified. Expect updates from the manufacturer.
Keep the recall notice, model numbers, and manufacturing dates. Save correspondence with the manufacturer and healthcare provider.
Model numbers affected include R8KILTBLOCKER10X12, R8KILTBLOCKER12X12, R8KILTBLOCKER18X20, R8KILTBLOCKER20X24, R8KILTBLOCKER24X24, S8KILTBLOCKER10X10, S8KILTBLOCKER10X12, S8KILTBLOCKER12X12, S8KILTBLOCKER18X20, S8KILTBLOCKER20X24, S8KILTBLOCKER24X24, U8KILTBLOCKER12X12, U8KILTBLOCKER18X20, U8KILTBLOCKER20X24, U8KILTBLOCKER24X24. All serial numbers manufactured with Xenolite 800 attenuation material between 2025-01-16 and 2026-01-21 are affected. Distribution is worldwide to hospitals, clinics, and other healthcare providers.
No injuries or incidents have been reported.
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