Olympus Corporation of the Americas: Medical Device Recall in 2024 - (Recall #: Z-1167-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

ESG PK CUTTING FORCEPS, 5MM, 33CM

Product Classification:

Class II

Date Initiated: December 15, 2023

Date Posted: February 28, 2024

Recall Number: Z-1167-2024

Event ID: 93842

Reason for Recall:

The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.

Status: Ongoing

Product Quantity: 11,123 units

Code Information:

Model: PK-CF0533; UDI DI: 00821925035867; Lot Numbers: FR258486, FR261738, FR259544, FR263183, FR276278, FR279757, FR279625, FR279658, FR286369, FR287112, FR374622, FR207935, FR212413, FR212735, FR215061, FR216817, FR220525, FR222456, FR227254, FR227774, FR227781, FR232882, FR234845, FR247614, FR240430, FR246627, FR247039, FR248008, FR255679, FR248312, FR263636, FR263244, FR269280, FR269267, FR269269, FR287114, FR303799, FR297022, FR301062, PWO-308561, PWO-308562, PWO-308563, PWO-308560, PWO-308567, PWO-308566, PWO-308565, FR303864, FR313639, FR316869, FR319703, FR316872, FR327890, PWO-308972, FR335984, FR335990, FR337947, FR373912, FR401646, FR379790, FR347006;

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Mexico, P.R. China, Singapore, South Korea.

Voluntary or Mandated:

Voluntary: Firm initiated