OLYMPUS ShockPulse-SE Lithotripsy System — Class II medical device recall Z-2197-2020
Terminated recall by Olympus Corporation of the Americas, reported 2020-06-10, distributed nationwide. A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allo
| Recall number | Z-2197-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2020-04-23 |
| Classified | 2020-06-01 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2024-10-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 18 |
| Lot numbers | CG2000, CG2001, CG2003, CG2004, CG2006, CG2007, CG2008, CG2010, CG2011, CG2012, CG2013, CG2015, CG2019, CG2021, CG2022, CG2025, CG2026, CG2027, CG2029, CG2033, CG2035, CG2036, CG2037 |
| Serial numbers | 1910PW30607601, 1910PW30607603, 1910PW30607701, 1910PW30607705, 1910PW30607706, 1910PW30607708, 1910PW30607709, 1910PW30607712, 1910PW30607713, 1910PW30607802, 1910PW30607803, 1910PW30607804, 1910PW30607808, 1910PW30607809, 1910PW30607814, 1910PW30607906 |
Product
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Reason for recall
A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2197-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.