Olympus Corporation of the Americas: Medical Device Recall in 2020 - (Recall #: Z-2197-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer

Product Classification:

Class II

Date Initiated: April 23, 2020

Date Posted: June 10, 2020

Recall Number: Z-2197-2020

Event ID: 85558

Reason for Recall:

A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.

Status: Terminated

Product Quantity: 18

Code Information:

Serial numbers: 1910PW30607705, 1910PW30607712, 1910PW30607601, 1910PW30607708, 1910PW30607709, 1910PW30607701, 1910PW30607814, 1910PW30607906, 1910PW30607603, 1910PW30607706, 1910PW30607802, 1910PW30607808, 1910PW30607809, 1910PW30607804, 1910PW30607713, 1910PW30607803 Lot Numbers: CG2003, CG2010, CG2011, CG2026, CG2027, CG2033, CG2035, CG2000, CG2025, CG2001, CG2019, CG2022, CG2029, CG2021, CG2008, CG2036, CG2037, CG2006, CG2004, CG2007, CG2012, CG2013, CG2015

Distribution Pattern:

Distribution US nationwide to states of: Texas, Ohio, New Mexico, California, Oklahoma, Michigan, Connecticut, North Carolina, Nebraska, and Pennsylvania; and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated