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
- Attenuation Blocker Device
- Model numbers
- R8BLOCKER1, R8BLOCKER2, R8BLOCKER3, R8BLOCKER4, R8BLOCKER5, R8BLOCKER6, S8BLOCKER1, S8BLOCKER2 +2 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
Blockers are attenuation devices produced by Burlington Medical and used in certain medical procedures where attenuation control is required.
Why This Is Dangerous
Over time the attenuation material may degrade, reducing device lifespan and potentially compromising performance.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Clinicians may need to replace affected devices, potentially delaying procedures and increasing administrative work for recalls.
Practical Guidance
How to identify if yours is affected
- Identify the model number from the device label: R8BLOCKER1-6, S8BLOCKER1-3, U8BLOCKER1.
- Check the UDI-DI where listed: BLOCKER8-R8BLOCKER1 through BLOCKER8-U8BLOCKER1.
- Verify the manufacturing date window: 2025-01-16 to 2026-01-21.
Where to find product info
UDI-DI on the device label and packaging; recall notice letters from Burlington Medical.
What timeline to expect
Refunds or replacements typically take 4-8 weeks after processing.
If the manufacturer is unresponsive
- Document all communications with Burlington Medical.
- File a consumer product safety complaint with CPSC if the company remains unresponsive.
- Consult your healthcare provider for interim management and replacement options.
How to prevent similar issues
- Verify attenuation-related components before use in any device applications.
- Ask suppliers for documentation on attenuation material and part dates.
- Monitor recall notices and register for updates from the manufacturer.
Documentation advice
Keep the recall letter, take photos of the device label, saving the model and UDI-DI, and maintain a log of communications.
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Product Details
Models: R8BLOCKER1, R8BLOCKER2, R8BLOCKER3, R8BLOCKER4, R8BLOCKER5, R8BLOCKER6, S8BLOCKER1, S8BLOCKER2, S8BLOCKER3, U8BLOCKER1. UDI-DI codes listed with each model: BLOCKER8-R8BLOCKER1, BLOCKER8-R8BLOCKER2, BLOCKER8-R8BLOCKER3, BLOCKER8-R8BLOCKER4, BLOCKER8-R8BLOCKER5, BLOCKER8-R8BLOCKER6, BLOCKER8-S8BLOCKER1, BLOCKER8-S8BLOCKER2, BLOCKER8-S8BLOCKER3, BLOCKER8-U8BLOCKER1. Material: Xenolite 800 attenuation material. Manufactured with this material from 2025-01-16 to 2026-01-21. Distribution: Worldwide including US, Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Peru,
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Total recalled: 51 units
- Active recall status as of 2026-04-08
- Manufacture window: 2025-01-16 to 2026-01-21
- Distribution: Worldwide to US, Canada, and additional international markets
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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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