Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2197-2020·Announced 2020-06-10

Olympus ShockPulse-SE Lithotripsy Transducers Recalled for Material Defect

Olympus is recalling 18 ShockPulse-SE Lithotripsy System transducers because a component was made with non-conforming material that could allow water ingress during sterilization.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential defect (water ingress) without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Olympus Corporation of the Americas is recalling 18 units of the OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer. The recall was initiated because a component of the transducer was manufactured with non-conforming material. This defect could allow water ingress during the autoclaving sterilization process.

The affected units were distributed nationwide in the United States to Texas, Ohio, New Mexico, California, Oklahoma, Michigan, Connecticut, North Carolina, Nebraska, and Pennsylvania, as well as to Canada. The recall includes specific serial numbers and lot numbers, which are listed in the official agency documentation.

Healthcare facilities and consumers should stop using the affected transducers immediately. Olympus is the recalling firm and is responsible for managing the recall. Users should contact Olympus or their local FDA office for instructions on how to return or replace the devices.

The recalled product

Product: OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Lithotripsy System
Hazard: water-ingress
sterilization-failure
Affected units: 18

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Same manufacturer · Olympus Corporation of the Americas

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