Recall Z-1418-2023— Olympus Corporation of the Americas

Name: FDA recall Z-1418-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-23

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2023-02-23. It names one FDA 510(k) clearance: K013066. 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: There have been complaints that the clip did not come out of the tube sheath during the procedure..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2023-02-23
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K013066 — HX-5/6-1 ENDOSCOPIC CLIPPING DEVICEOlympus America, Inc.·cleared 2001-12-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.