Electrohydraulic lithotripter probe — Class II medical device recall Z-0073-2018
Terminated recall by Northgate Technologies, Inc., reported 2017-11-15, distributed in MA, NE, TN. The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. According to Nor
| Recall number | Z-0073-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Northgate Technologies, Inc., Elgin, IL, United States |
| Recall initiated | 2017-05-24 |
| Classified | 2017-11-08 |
| Reported by FDA | 2017-11-15 |
| Terminated | 2020-06-09 |
| Distributed | MA, NE, TN |
| Countries outside the US | CA |
| Quantity | 186 |
| Reason classes | labeling |
| Serial numbers | LDS12516 |
| Model numbers | 9-195-371DS, 9-201-00 |
Product
Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.
Reason for recall
The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. According to Northgate Technologies, the resistor in the probe will not allow the mislabeled product to be used with the incorrect generator. Could Delay Care.
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-0073-2018. 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.