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U.S. Department of Health and Human Services

Class 2 Device Recall Burlington Medical, Leg Wraps

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 Class 2 Device Recall Burlington Medical, Leg Wrapssee related information
Date Initiated by FirmFebruary 11, 2026
Date PostedApril 02, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1761-2026
Recall Event ID 98415
Product Classification Apron, protective - Product Code IWO
ProductBurlington Medical, Leg Wraps.
Code Information All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8LGW1; UDI-DI (Product Code): 00840331272079 (LGW8SET-R8LGW1). 2. Model Number: R8LGW2; UDI-DI (Product Code): 00840331272086 (LGW8SET-R8LGW2). 3. Model Number: R8LGW3; UDI-DI (Product Code): 00840331272055 (LGW8SET-R8LGW3). 4. Model Number: S8LGW1; UDI-DI (Product Code): 00840331272116 (LGW8SET-S8LGW1). 5. Model Number: S8LGW2; UDI-DI (Product Code): 00840331272123 (LGW8SET-S8LGW2). 6. Model Number: S8LGW3; UDI-DI (Product Code): 00840331272093 (LGW8SET-S8LGW3). 7. Model Number: S8LGW4; UDI-DI (Product Code): 00840331272109 (LGW8SET-S8LGW4). 8. Model Number: U8LGW1; UDI-DI (Product Code): 00840331272154 (LGW8SET-U8LGW1). 9. Model Number: U8LGW2; UDI-DI (Product Code): 00840331272161 (LGW8SET-U8LGW2). 10. Model Number: U8LGW4; UDI-DI (Product Code): 00840331272147 (LGW8SET-U8LGW4).
FEI Number 1000120804
Recalling Firm/
Manufacturer		 Burlington Medical, LLC
3 Elmhurst St
Suite 112
Newport News VA 23603-1137
For Additional Information ContactRoger West
757-8888994
Manufacturer Reason
for Recall		Potential for attenuation degradation over time, decreasing the lifespan.
FDA Determined
Cause 2		Process change control
ActionBurlington Medical notified consignees on about 02/11/2026 via "URGENT - FIELD SAFETY NOTICE (FSN)" letter. Consignees were instructed to ensure all users of the specific Burlington Medical radiation protection garments made aware of this Recall Notice, review inventory for affected units, arrange for the return of those affected units for proper disposal, and complete and return the Recall Response Form. Consignees were also instructed to notify appropriate individuals within your organization and to any organization where the potentially affected devices were transferred or sold.
Quantity in Commerce103 units
DistributionWorldwide distribution. Nationwide distribution in the US and international distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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