Olympus Corporation of the Americas: Medical Device Recall in 2023 - (Recall #: Z-1418-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: February 23, 2023

Date Posted: April 26, 2023

Recall Number: Z-1418-2023

Event ID: 91840

Reason for Recall:

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

Status: Ongoing

Product Quantity: 65.9 boxes (373 pieces)

Code Information:

1) UDI-DI 14953170353106; Model HX-201LR-135; Lot 1ZV 2) UDI-DI 14953170353113; Model HX-201UR-135; Lot 23V 3) UDI-DI 14953170353120; Model HX-201UR-135; Lot 24V 4) UDI-DI 14953170353168; Model HX-201UR-135L; Lot 24V

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated