Burlington Medical, Leg Wraps.

FDA device recall Z-1761-2026 · posted 2026-04-02 · Open, Classified

Recall details

Recalling firm

Burlington Medical, LLC

Reason for recall

Potential for attenuation degradation over time, decreasing the lifespan.

Action taken

Burlington 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.

Root cause

Process change control

Status

Open, Classified

Product code

IWO

Quantity affected

103 units

Distribution

Worldwide distribution. Nationwide distribution in the US and international distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwa

Date initiated

2026-02-11

Date posted

2026-04-02

Location

Newport News, VA