CLASS II Device recall · Reported 15 Jun 2022 · FDA Enforcement Report
Autolith Touch 9F Biliary Electrohydraulic Lithotripter Probe recalled
Northgate Technologies is recalling Autolith Touch 9F Biliary Electrohydraulic Lithotripter Probe, distributed nationwide in the US. The recall was initiated on 13 Apr 2022 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-1235-2022
- FDA event ID
- 90095
- Recalling firm
- Northgate Technologies, Elgin, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Apr 2022
- FDA classified
- 3 Jun 2022
- Reported
- 15 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 13 Apr 2022 | Recall initiated by company | |
| 3 Jun 2022 | Classified by FDA | +51 days |
| 15 Jun 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product labeled incorrectly.
Product as listed by the FDA
AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
Where it was distributed
US Nationwide distribution in the state of MA.
Questions about this recall
Is Autolith Touch 9F Biliary Electrohydraulic Lithotripter Probe recalled?
Yes. Northgate Technologies recalled Autolith Touch 9F Biliary Electrohydraulic Lithotripter Probe on 13 Apr 2022. The recall is Class II and its status is Terminated. Recall number Z-1235-2022.
Why was it recalled?
Product labeled incorrectly.
Which lots are affected?
NTI Catalog Number 72-00322-0 / BSC Catalog No. M00546620; Lot code: BSC15876; GTIN: 00817183020448.
Where was it sold?
US Nationwide distribution in the state of MA.
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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