# FDA recall Z-1883-2020

> **Northgate Technologies, Inc.** · Class II · device recall initiated 2020-03-10.

## Product

Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.

## Reason for recall

As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

## Distribution

US Nationwide distribution. No governmental.

## Key facts

- **Recall number:** Z-1883-2020
- **Recalling firm:** Northgate Technologies, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-10
- **Report date:** 2020-05-13
- **Termination date:** 2021-02-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Elgin, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1883-2020

## Citation

> AI Analytics. FDA recall Z-1883-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1883-2020. Source: US FDA. Licensed CC0.

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