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
- Frontal X-ray Attenuation Apron
- Model numbers
- C8F17, FRONTALC18-C8F17-2XM, FRONTALC8-C8F17-LF, FRONTALC8-C8F17-LM, FRONTALC8-C8F17-MF, FRONTALC8-C8F17-MM, FRONTALC8-C8F17-SF, FRONTALC8-C8F17-SM +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
Frontal aprons are radiation-shielding garments worn by healthcare workers during X-ray procedures to protect vital organs.
Why This Is Dangerous
Over time, the Xenolite 800 attenuation material may degrade, reducing shielding effectiveness and potentially increasing radiation exposure risk.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals and clinics may need to halt use of affected aprons and coordinate replacements, potentially impacting workflow and safety budgets.
Practical Guidance
How to identify if yours is affected
- Check model numbers listed in the recall against your inventory.
- Review manufacturing dates to see if your aprons fall within 2025-01-16 to 2026-01-21 window.
- Inspect UDI-DI codes if available on labels (e.g., FRONTALC18-C8F17-2XM, FRONTALC8-R8601-LF, etc.).
Where to find product info
UDI-DI labels, product tags, and device documentation.
What timeline to expect
Remedy details will be issued by Burlington Medical; expect replacement or repair guidance to follow recall notices.
If the manufacturer is unresponsive
- Escalate to hospital compliance or safety officer.
- Document your outreach attempts and keep records of replies.
How to prevent similar issues
- Verify shielding material quality during procurement.
- Ask for documentation of shielding material integrity and certification.
- Establish a recall tracking process for all protective garments.
Documentation advice
Keep a record of the recall notice, model numbers, date codes, correspondence with the manufacturer, and any replacement shipments.
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Product Details
Model numbers include C8F17 and the R8601 family, with multiple UDI-DI codes listed. Distributed worldwide, including US nationwide and international markets (Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, Vietnam). Manufactured with Xenolite 800 attenuation material from 2025-01-16 to 2026-01-21. Quantity: 14,323 units. Sold through worldwide distribution to healthcare facilities.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution and nationwide US distribution
- Two model families affected: C8F17 and R8601
- Manufacture date range affected: 2025-01-16 to 2026-01-21
- AXIAL shielding material Xenolite 800 used in affected units
- High hazard level (attenuation degradation)
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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