Recall Z-1760-2026 ยท IWO Apron, Protective
Burlington Medical, LLC
Burlington Medical, Caps.
| Date | Apr 2, 2026 (initiated Feb 11, 2026) |
| Status | Open, Classified |
| Reason | Potential for attenuation degradation over time, decreasing the lifespan. |
| Root cause | Process change control |
| 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. |
| Quantity | 961 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, Taiwan, Uruguay, and Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.