Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name:… — Class II medical device recall Z-1477-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2026-03-11, distributed nationwide. Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase w
| Recall number | Z-1477-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2025-11-14 |
| Classified | 2026-02-27 |
| Reported by FDA | 2026-03-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BO, CA, CL, CN, IN, JP, KR, MX, SG |
| Quantity | 602 units |
| UPC / GTIN / UDI-DI | 00821925043824 |
Product
Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
Reason for recall
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
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-1477-2026. 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.