Quick Facts at a Glance
- Recall Date
- February 11, 2026
- Hazard Level
- HIGH
- Brand
- Burlington Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Caps
- Model numbers
- R8CAP, S8CAP, U8CAP
- Sold at
- Unknown
- 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
Burlington Medical caps are used in medical devices that require attenuation materials for shielding. They are distributed worldwide to healthcare providers.
Why This Is Dangerous
Attenuation material may degrade over time, reducing the shielding lifespan and potentially affecting device performance.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The recall could disrupt medical workflows if devices in use require replacement or servicing. No injuries reported to date.
Practical Guidance
How to identify if yours is affected
- Check model numbers R8CAP, S8CAP, U8CAP.
- Verify Xenolite 800 attenuation material used in the cap.
- Check manufacture date 2025-01-16 to 2026-01-21.
Where to find product info
Serial numbers and UDIs are on the device labeling and packaging.
What timeline to expect
4-8 weeks for recall processing and replacement or disposition.
If the manufacturer is unresponsive
- Document all communications with Burlington Medical.
- File a complaint with the FDA if the manufacturer is unresponsive.
- Keep a record of all correspondence and dates.
How to prevent similar issues
- Verify recall status before use or purchase of medical caps.
- Ask for model numbers and serials before accepting devices.
- Inspect attenuation materials and documentation for Xenolite 800 in future purchases.
Documentation advice
Keep the recall notice, model numbers, UDIs, and all correspondence. Photograph labels and packaging for records.
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Product Details
Quantity: 961 units. Distribution: Worldwide. Models: R8CAP, S8CAP, U8CAP. UDI-DI codes: 00840331272185 (CAP8-R8CAP-LG_XL), 00840331272178 (CAP8-R8CAP-SM_MD); 00840331272208 (CAP8-S8CAP-LG_XL), 00840331272192 (CAP8-S8CAP-SM_MD); 00840331272222 (CAP8-U8CAP-LG_XL), 00840331272215 (CAP8-U8CAP-SM_MD). Manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. Sold to healthcare providers worldwide. Price not disclosed.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution including US and multiple international markets
- Affects model numbers R8CAP, S8CAP, U8CAP
- Date range of manufacture 2025-01-16 to 2026-01-21
- UDI codes provided for each model
- Remedy: stop use and follow manufacturer instructions
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Safety Guide
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