Z-1765-2026Class II

Burlington Medical, Kilt Blockers

Name: Z-1765-2026 Burlington Medical, Kilt Blockers
Creator: Burlington Medical, LLC
Published: 2026-02-11
License: https://open.fda.gov/license/

Burlington Medical LLC / initiated 2026-02-11 / Open, Classified

FDA source

Burlington Medical, LLC began a recall of Burlington Medical, Kilt Blockers on 2026-02-11. FDA classified it as Class II and gives the reason as "Potential for attenuation degradation over time, decreasing the lifespan". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1765-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-11
Posted: 2026-04-02
Recalling firm: Burlington Medical LLC
Product: Burlington Medical, Kilt Blockers.
Product code: IWO Apron, Protective
Reason for recall: Potential for attenuation degradation over time, decreasing the lifespan.
FDA 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 in commerce: 94 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.
Product codes and lots: All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8KILTBLOCKER10X12; UDI-DI (Product Code): 00840331272727 (KILTBLOCKER8-R8KILTBLOCKER10X12). 2. Model Number: R8KILTBLOCKER12X12; UDI-DI (Product Code): 00197513011293 (KILTBLOCKER8-R8KILTBLOCKER12X12). 3. Model Number: R8KILTBLOCKER18X20; UDI-DI (Product Code): 00840331272741 (KILTBLOCKER8-R8KILTBLOCKER18X20). 4. Model Number: R8KILTBLOCKER20X24; UDI-DI (Product Code): 00840331272758 (KILTBLOCKER8-R8KILTBLOCKER20X24). 5. Model Number: R8KILTBLOCKER24X24; UDI-DI (Product Code): 00840331272765 (KILTBLOCKER8-R8KILTBLOCKER24X24). 6. Model Number: S8KILTBLOCKER10X10; UDI-DI (Product Code): 00840331272772 (KILTBLOCKER8-S8KILTBLOCKER10X10). 7. Model Number: S8KILTBLOCKER10X12; UDI-DI (Product Code): 00840331272789 (KILTBLOCKER8-S8KILTBLOCKER10X12). 8. Model Number: S8KILTBLOCKER12X12; UDI-DI (Product Code): 00197513011309 (KILTBLOCKER8-S8KILTBLOCKER12X12). 9. Model Number: S8KILTBLOCKER18X20; UDI-DI (Product Code): 00840331272802 (KILTBLOCKER8-S8KILTBLOCKER18X20). 10. Model Number: S8KILTBLOCKER20X24; UDI-DI (Product Code): 00840331272819 (KILTBLOCKER8-S8KILTBLOCKER20X24). 11. Model Number: S8KILTBLOCKER24X24; UDI-DI (Product Code): 00840331272826 (KILTBLOCKER8-S8KILTBLOCKER24X24). 12. Model Number: U8KILTBLOCKER12X12; UDI-DI (Product Code): 00197513011316 (KILTBLOCKER8-U8KILTBLOCKER12X12). 13. Model Number: U8KILTBLOCKER18X20; UDI-DI (Product Code): 00840331272864 (KILTBLOCKER8-U8KILTBLOCKER18X20). 14. Model Number: U8KILTBLOCKER20X24; UDI-DI (Product Code): 00840331272871 (KILTBLOCKER8-U8KILTBLOCKER20X24). 15. Model Number: U8KILTBLOCKER24X24; UDI-DI (Product Code): 00840331272888 (KILTBLOCKER8-U8KILTBLOCKER24X24).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1765-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1753-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1754-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1755-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1756-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1757-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1758-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1759-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1760-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1761-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1762-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1763-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1764-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1765-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02

Product code IWO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)