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
- Kilt Blocker
- Model numbers
- R8KILTBLOCKER10X12, R8KILTBLOCKER12X12, R8KILTBLOCKER18X20, R8KILTBLOCKER20X24, R8KILTBLOCKER24X24, S8KILTBLOCKER10X10, S8KILTBLOCKER10X12, S8KILTBLOCKER12X12 +7 more
- Sizes
- 10x12, 12x12, 18x20, 20x24, 24x24 +10 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
Kilt Blockers are medical devices produced by Burlington Medical for use in clinical settings. This recall affects devices manufactured with Xenolite 800 attenuation material during a defined period and distributed worldwide.
Why This Is Dangerous
Attenuation degradation over time may shorten device lifespan and impact performance. This creates a potential safety concern in clinical use.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Affecting 94 units, the recall could require clinicians to replace or service affected devices. No injuries have been reported yet. Consumers should stop using affected devices immediately.
Practical Guidance
How to identify if yours is affected
- Identify if your device is one of the listed models.
- Check if the device was manufactured 2025-01-16 to 2026-01-21 and includes Xenolite 800 material.
- Confirm distribution status as worldwide.
Where to find product info
Consult the FDA enforcement page for recall Z-1765-2026 and Burlington Medical recall communications.
What timeline to expect
Recall events began on 2026-02-11; resolution timelines are not specified. Expect updates from the manufacturer.
If the manufacturer is unresponsive
- File a complaint with the FDA or CPSC if the manufacturer is unresponsive.
- Document all contact attempts and responses.
How to prevent similar issues
- When purchasing, verify attenuation materials and model numbers.
- Ask for documentation on device durability and recall status.
- Monitor for recall updates from the manufacturer and FDA.
Documentation advice
Keep the recall notice, model numbers, and manufacturing dates. Save correspondence with the manufacturer and healthcare provider.
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Product Details
Model numbers affected include R8KILTBLOCKER10X12, R8KILTBLOCKER12X12, R8KILTBLOCKER18X20, R8KILTBLOCKER20X24, R8KILTBLOCKER24X24, S8KILTBLOCKER10X10, S8KILTBLOCKER10X12, S8KILTBLOCKER12X12, S8KILTBLOCKER18X20, S8KILTBLOCKER20X24, S8KILTBLOCKER24X24, U8KILTBLOCKER12X12, U8KILTBLOCKER18X20, U8KILTBLOCKER20X24, U8KILTBLOCKER24X24. All serial numbers manufactured with Xenolite 800 attenuation material between 2025-01-16 and 2026-01-21 are affected. Distribution is worldwide to hospitals, clinics, and other healthcare providers.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Attenuation material: Xenolite 800
- Manufacture window: 2025-01-16 to 2026-01-21
- Recall status: ACTIVE
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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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