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Open, Classified

Burlington Medical, Protective Sleeves.

FDA Recall Z-1759-2026 · Posted 2026-04-02

Recalling FirmBurlington Medical, LLC
Recall StatusOpen, Classified
Product CodeIWO
Date Initiated2026-02-11
Product Quantity1,129 units

Reason for Recall

Potential for attenuation degradation over time, decreasing the lifespan.

Firm Action

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

Distribution Pattern

Worldwide 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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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