Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter — Class II medical device recall Z-0333-2022
Ongoing recall by Northgate Technologies, Inc., reported 2021-12-15. The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in th
| Recall number | Z-0333-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Northgate Technologies, Inc., Elgin, IL, United States |
| Recall initiated | 2021-10-25 |
| Classified | 2021-12-03 |
| Reported by FDA | 2021-12-15 |
| Quantity | 2,277 devices |
| UPC / GTIN / UDI-DI | 00817183020493 |
| Model numbers | M005466800 |
Product
Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.
Reason for recall
The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
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-0333-2022. 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.