HIGH

Burlington Medical Kilt Recall: 15,216 Units Worldwide Over Attenuation Degradation (2026)

Burlington Medical recalled 15,216 Kilt devices distributed worldwide. The recall follows a potential degradation in attenuation over time that could shorten the device lifespan. Stop using the device immediately and follow the manufacturer’s recall instructions, per the company and FDA notice dated 2026-02-11.

Quick Facts at a Glance

Recall Date
February 11, 2026
Hazard Level
HIGH
Brand
Burlington Medical
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

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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About This Product

The Burlington Medical Kilt is a medical device that employs Xenolite 800 attenuation material. It has a worldwide distribution through healthcare channels since 2025.

Why This Is Dangerous

Attenuation material degradation over time could reduce the device’s lifespan and effectiveness, potentially compromising its shielding function.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

The recall affects 15,216 units globally. There are no reported injuries or incidents at this time. The recall is active and ongoing.

Practical Guidance

How to identify if yours is affected

  1. Check if your device is labeled with model numbers in the recall list (C8K303 and FKILTC8-C8K303 variants).
  2. Verify if your device contains Xenolite 800 attenuation material.
  3. Confirm manufacture date between 01/16/2025 and 01/21/2026.

Where to find product info

Model numbers and UDI codes are listed in the recall notice and FDA enforce page. Look on the device label and accompanying documentation.

What timeline to expect

Remedy processing typically takes 4-8 weeks after qualification steps.

If the manufacturer is unresponsive

  • Escalate to the manufacturer with documented requests
  • File a recall complaint with FDA if the manufacturer remains unresponsive
  • Consult your healthcare provider for interim guidance

How to prevent similar issues

  • Always verify attenuation materials and model numbers when acquiring similar devices
  • Request confirmation of attenuation material from suppliers
  • Monitor for recall updates and official remedies

Documentation advice

Keep copies of the recall notice, model numbers, UDI codes, dates, and all correspondence with the manufacturer for records.

Product Details

Model numbers span a range of FKIL and TT variants with C8K303 primary model. Affected units were manufactured with Xenolite 800 attenuation material between 01/16/2025 and 01/21/2026. 15,216 units distributed worldwide. UDI codes and product codes include: 00840331297638 (FKILTC18-C8K303-2XM), FKILTC8-C8K303-LF, FKILTC8-C8K303-LM, FKILTC8-C8K303-MF, FKILTC8-C8K303-MM, FKILTC8-C8K303-PLUS, FKILTC8-C8K303-SF, FKILTC8-C8K303-SM, FKILTC8-C8K303-XLF, FKILTC8-C8K303-XLM, FKILTC8-C8K303-XSF, FKILTT18-C8K303-LM, FKILTT18-C8K303-MM, FKILTT18-C8K303-PLUS, FKILTT18-C8K303-SM, FKILTT18-C8K303-XLM, FKILTT

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 15,216 units recalled
  • Worldwide distribution including US and multiple international markets
  • Attenuation material Xenolite 800 involved
  • Manufacture window 01/16/2025 to 01/21/2026
  • Model numbers include C8K303 and FKILTC8-C8K303 variants

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
C8K303
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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