# FDA recall Z-2285-2023

> **Scican Ltd.** · Class II · device recall initiated 2023-06-22.

## Product

STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.  Model: G4 621103

## Reason for recall

The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, bio medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.

## Distribution

US Nationwide Distribution and in the country of Canada

## Key facts

- **Recall number:** Z-2285-2023
- **Recalling firm:** Scican Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-22
- **Report date:** 2023-08-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North York, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2285-2023

## Citation

> AI Analytics. FDA recall Z-2285-2023. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-2285-2023. Source: US FDA. Licensed CC0.

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