FDA Device recall Z-1759-2026

Burlington Medical, Protective Sleeves

FDA Device
Class II
ongoing
Published 2026-04-08

On 2026-04-08 the FDA classified a Class II recall of Burlington Medical, Protective Sleeves by Burlington Medical, citing potential for attenuation degradation over time, decreasing the lifespan.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1759-2026
Classification	Class II
Status	ongoing
Initiated	2026-02-11
Published	2026-04-08
Last updated	2026-09-13 11:58 UTC
Company	Burlington Medical
Distribution	US

Product

Burlington Medical, Protective Sleeves.

Reason

Potential for attenuation degradation over time, decreasing the lifespan.

Identifiers

code_info	All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/… All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8SL; UDI-DI (Product Code): 00840331271904 (SL8-R8SL). 2. Model Number: R8SL3; UDI-DI (Product Code): 00840331271911 (SL38-R8SL3-LG), 00840331271928 (SL38-R8SL3-MD), 00840331271935 (SL38-R8SL3-SM), 00840186699816 (SL38-R8SL3-XL), 00840331271942 (SL38-R8SL3-XS). 3. Model Number: S8SL; UDI-DI (Product Code): 00840331271959 (SL8-S8SL). 4. Model Number: S8SL3; UDI-DI (Product Code): 00840331271966 (SL38-S8SL3-LG), 00840331271973 (SL38-S8SL3-MD), 00840331271980 (SL38-S8SL3-SM), 00840186699823 (SL38-S8SL3-XL), 00840331271997 (SL38-S8SL3-XS). 5. Model Number: U8SL; UDI-DI (Product Code): 00840331272000 (SL8-U8SL). 6. Model Number: U8SL3; UDI-DI (Product Code): 00840331272017 (SL38-U8SL3-LG), 00840331272024 (SL38-U8SL3-MD), 00840331272031 (SL38-U8SL3-SM), 00840186699830 (SL38-U8SL3-XL), 00840331272048 (SL38-U8SL3-XS).

code_info

All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/…

All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8SL; UDI-DI (Product Code): 00840331271904 (SL8-R8SL). 2. Model Number: R8SL3; UDI-DI (Product Code): 00840331271911 (SL38-R8SL3-LG), 00840331271928 (SL38-R8SL3-MD), 00840331271935 (SL38-R8SL3-SM), 00840186699816 (SL38-R8SL3-XL), 00840331271942 (SL38-R8SL3-XS). 3. Model Number: S8SL; UDI-DI (Product Code): 00840331271959 (SL8-S8SL). 4. Model Number: S8SL3; UDI-DI (Product Code): 00840331271966 (SL38-S8SL3-LG), 00840331271973 (SL38-S8SL3-MD), 00840331271980 (SL38-S8SL3-SM), 00840186699823 (SL38-S8SL3-XL), 00840331271997 (SL38-S8SL3-XS). 5. Model Number: U8SL; UDI-DI (Product Code): 00840331272000 (SL8-U8SL). 6. Model Number: U8SL3; UDI-DI (Product Code): 00840331272017 (SL38-U8SL3-LG), 00840331272024 (SL38-U8SL3-MD), 00840331272031 (SL38-U8SL3-SM), 00840186699830 (SL38-U8SL3-XL), 00840331272048 (SL38-U8SL3-XS).

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1759-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.