FDA recall Z-1418-2023

Olympus Corporation of the Americas · Class II · device

Product

Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip

Reason for recall

There have been complaints that the clip did not come out of the tube sheath during the procedure.

Distribution

US Nationwide Distribution

Key facts

Status: Ongoing
Initiation date: 2023-02-23
Report date: 2023-04-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1418-2023