Autolith Uro-Tch 9fr Probe 54cm recallZ-1884-2020 · Northgate Technologies, Inc. · initiated Mar 10, 2020
Class II Terminated All recalls posted in March 2020
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
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Northgate Technologies, Inc. notified customers on 03/11/2020 via "Urgent: medical Device Recall Notification" email. The recall notice identified the affected and requested the customers to cease distribution and destroy affected product. The customers were asked to complete the "Recall Acknowledgment Form".
Recall details
- Recall number
- Z-1884-2020
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 10, 2020
- Posted by the FDA
- Mar 24, 2020
- Recalling firm
- Northgate Technologies, Inc.
- Quantity
- 198 boxes. 3 units per box.
- Product code
- FFK
- FDA submissions
- K130368
- Distribution
- US Nationwide distribution. No governmental.
Product description
AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
Code information (models, lots, serial numbers)
NTI Catalog Number 9-203-0543.
Other devices under the same FDA submission
3 devices cleared under K130368 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Lithotripsy Probe 1.9FR 375cm DS M00546620Northgate Technologies Inc. · Lithotriptor, Electro-Hydraulic1 recall1 death19 reports
- Autolith Touch M005466800Northgate Technologies Inc. · Lithotriptor, Electro-Hydraulic1 recall12 reports
- Autolith Touch M0054668R0Northgate Technologies Inc. · Lithotriptor, Electro-Hydraulic1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 85204).
- Z-1883-2020 · TerminatedProbe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
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 18, 2026. Text above is shown as published by the FDA.
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