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
- Protective Sleeves
- Model numbers
- R8SL, R8SL3, SL8-R8SL, SL38-R8SL3-LG, SL38-R8SL3-MD, SL38-R8SL3-SM, SL38-R8SL3-XL, SL38-R8SL3-XS +14 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
Burlington Medical protective sleeves are medical device components used in clinical settings to provide protective coverage. They are distributed globally to hospitals and health systems.
Why This Is Dangerous
Attenuation degradation over time reduces the device’s lifespan and could affect performance in medical procedures.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Healthcare facilities may need to replace affected sleeves earlier than planned, potentially affecting inventory and procedures until replacements are secured.
Practical Guidance
How to identify if yours is affected
- Check model numbers against the recall list.
- Verify Xenolite 800 attenuation material was used in your units and confirm the manufacturing window 2025-01-16 to 2026-01-21.
- Assess inventory to identify any affected sleeves in use or storage.
Where to find product info
Labels or packaging should include model numbers and UDI codes as shown in the recall.
What timeline to expect
4-8 weeks for refunds or replacements once authorized by the manufacturer and supplier.
If the manufacturer is unresponsive
- Document all outreach attempts with the vendor.
- Escalate to hospital procurement leadership or compliance.
- File a consumer complaint with the CPSC if appropriate.
How to prevent similar issues
- Vet attenuation materials in new sleeves before purchasing.
- Request documentation of material stability and lifespan from suppliers.
- Prefer products with clear recall history and adverse-event reporting.
Documentation advice
Maintain copies of purchase receipts, model numbers, packaging labels, and all correspondence with Burlington Medical or distributors.
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Product Details
Model numbers: R8SL; R8SL3; SL8-R8SL; SL38-R8SL3-LG; SL38-R8SL3-MD; SL38-R8SL3-SM; SL38-R8SL3-XL; SL38-R8SL3-XS; S8SL; SL8-S8SL; SL38-S8SL3-LG; SL38-S8SL3-MD; SL38-S8SL3-SM; SL38-S8SL3-XL; SL38-S8SL3-XS; U8SL; SL8-U8SL; SL38-U8SL3-LG; SL38-U8SL3-MD; SL38-U8SL3-SM; SL38-U8SL3-XL; SL38-U8SL3-XS Sold at: Worldwide distribution, including the United States and Canada, plus Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, Vietnam When sold: Manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026 Price: Unknown Quantity: 1
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 1129 total units recalled
- Attenuation material: Xenolite 800
- Manufacture date window: 2025-01-16 to 2026-01-21
- Model numbers span R8SL, S8SL, U8SL families and variants
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Safety Guide
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