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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Burlington Medical
- Product type
- Radiation Attenuation Device
- Model numbers
- C8K303, FKILTC18-C8K303-2XM, FKILTC8-C8K303-LF, FKILTC8-C8K303-LM, FKILTC8-C8K303-MF, FKILTC8-C8K303-MM, FKILTC8-C8K303-PLUS, FKILTC8-C8K303-SF +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 11, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check if your device is labeled with model numbers in the recall list (C8K303 and FKILTC8-C8K303 variants).
- Verify if your device contains Xenolite 800 attenuation material.
- 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.
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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
- 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
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Safety Guide
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