AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic… recallZ-1235-2022 · Northgate Technologies, Inc. · initiated Apr 13, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Northgate Technologies, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product labeled incorrectly.
FDA root cause category: Under Investigation by firm
What the company is doing
The firm sent out the recall notification to their consignee on 04/13/2022 via email. The firm sent out a letter as well on 04/27/2022 which instructs the consignee to cease distribution, quarantine affected units and return affected product. If the distributor further distributed the product, they are asked to notify their customers.
Recall details
- Recall number
- Z-1235-2022
- Status
- Terminated
- Initiated by the company
- Apr 13, 2022
- Recalling firm
- Northgate Technologies, Inc.
- Quantity
- 55 probes
- Product code
- FFK
- FDA submissions
- K130368
- Distribution
- US Nationwide distribution in the state of MA.
Product description
AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
Code information (models, lots, serial numbers)
NTI Catalog Number 72-00322-0 / BSC Catalog No. M00546620; Lot code: BSC15876; GTIN: 00817183020448.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Lithotripsy Probe 1.9FR 375cm DS M00546620Northgate Technologies Inc. · Lithotriptor, Electro-Hydraulic1 recall1 death19 reports
Other devices under the same FDA submission
2 devices cleared under K130368 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Autolith Touch M005466800Northgate Technologies Inc. · Lithotriptor, Electro-Hydraulic1 recall12 reports
- Autolith Touch M0054668R0Northgate Technologies Inc. · Lithotriptor, Electro-Hydraulic1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page