HIGH

Burlington Medical, Kilt

Potential for attenuation degradation over time, decreasing the lifespan.

Quick Facts at a Glance

Recall Date
February 11, 2026
Hazard Level
HIGH
Brand
Burlington Medical
Geographic Scope
1 states

Hazard Information

Potential for attenuation degradation over time, decreasing the lifespan.

What You Should Do

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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Full Description

Burlington Medical, Kilt. Reason: Potential for attenuation degradation over time, decreasing the lifespan.. Classification: Class II. Quantity: 15,216 units. Distribution: Worldwide distribution. Nationwide distribution in the US and international distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam.

View Original Recall on FDA - Medical Devices

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Product Classification

Product Details

Model Numbers
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: C8K303
UDI-DI (Product Code): 00840331297638 (FKILTC18-C8K303-2XM
FKILTC8-C8K303-LF
FKILTC8-C8K303-LM
FKILTC8-C8K303-MF
+15 more
Affected States
ALL
Report Date
April 8, 2026
Recall Status
ACTIVE

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