CLASS II Device recall · Reported 15 Nov 2017 · FDA Enforcement Report
Electrohydraulic lithotripter probe recalled by Northgate Technologies
Northgate Technologies is recalling Electrohydraulic lithotripter probe, distributed nationwide in the US. The recall was initiated on 24 May 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0073-2018
- FDA event ID
- 77367
- Recalling firm
- Northgate Technologies, Elgin, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 May 2017
- FDA classified
- 8 Nov 2017
- Reported
- 15 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Surgical Instruments
Timeline
| 24 May 2017 | Recall initiated by company | |
| 8 Nov 2017 | Classified by FDA | +168 days |
| 15 Nov 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to the following states : MA, NE and TN and Internationally to Canada.
Questions about this recall
Is Electrohydraulic lithotripter probe recalled?
Yes. Northgate Technologies recalled Electrohydraulic lithotripter probe on 24 May 2017. The recall is Class II and its status is Terminated. Recall number Z-0073-2018.
Why was it recalled?
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.
Which lots are affected?
Model No. 9-195-371DS, Lot/Serial Number LDS12516
Where was it sold?
US Distribution to the following states : MA, NE and TN and Internationally to Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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