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
- Leg wrap (compression) device
- Model numbers
- R8LGW1, R8LGW2, R8LGW3, S8LGW1, S8LGW2, S8LGW3, S8LGW4, U8LGW1 +3 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
Leg wraps used for compression therapy, typically prescribed for edema or venous disease. They help manage swelling and improve circulation in the legs.
Why This Is Dangerous
Attenuation degradation over time can reduce device lifespan and performance, potentially compromising sustained compression.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may need to replace the device sooner than expected, incurring cost and coordinating with healthcare providers.
Practical Guidance
How to identify if yours is affected
- Check model numbers against the recall list: R8LGW1, R8LGW2, R8LGW3, S8LGW1, S8LGW2, S8LGW3, S8LGW4, U8LGW1, LGW8SET-U8LGW2, U8LGW4, LGW8SET-U8LGW4
- Verify Xenolite 800 attenuation material usage and manufacturing window 01/16/2025–01/21/2026
- Confirm serial numbers associated with affected lots if provided by the manufacturer
Where to find product info
Recall notice and model/UDI details are on the FDA enforcement page. Look for the recall Z-1761-2026 page.
What timeline to expect
Not specified in the recall; monitor FDA updates and follow manufacturer communications.
If the manufacturer is unresponsive
- Escalate to FDA Consumer Complaint Coordinator
- Consult your healthcare provider for interim guidance
- Seek legal advice if necessary
How to prevent similar issues
- When purchasing medical devices, verify model numbers and materials
- Register devices with the manufacturer if offered
- Check recall alerts on the FDA site regularly
Documentation advice
Keep the recall letter, model numbers, dates, and all communications with the manufacturer. Photograph the device and store all correspondence.
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Product Details
103 units recalled. Distribution: Worldwide, including US nationwide and international sites in Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam. Models affected include R8LGW1, R8LGW2, R8LGW3, S8LGW1, S8LGW2, S8LGW3, S8LGW4, U8LGW1, LGW8SET-U8LGW2, U8LGW4, LGW8SET-U8LGW4. All serial numbers manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026 are affected. UDI-DI codes: 00840331272079 (LGW8SET-R8LGW1) through 00840331272147 (LGW8SET-U8LGW4). Price not disclosed.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Manufactured with Xenolite 800 attenuation material
- Manufacturing window: 2025-01-16 to 2026-01-21
- Model numbers: R8LGW1, R8LGW2, R8LGW3, S8LGW1, S8LGW2, S8LGW3, S8LGW4, U8LGW1, LGW8SET-U8LGW2, U8LGW
- LGW8SET-U8LGW4
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Safety Guide
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