FDA-Device2020-06-10Class II
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Hazard
A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.
Sold states
Distribution US nationwide to states of: Texas, Ohio, New Mexico, California, Oklahoma, Michigan, Connecticut, North Carolina, Nebraska, and Pennsylvania; and Canada.
Affected count
18
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2197-2020More Olympus Corporation of the Americas recalls
- FDA-Device2026-07-22Olympus Ellik Evacuator Model 194 recalled for inadequate sterilization parameters
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Toomey Evacuator 50cc Model 188A recalled for inadequate sterilization parameters
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