Scican Ltd.: Medical Device Recall in 2023 - (Recall #: Z-2285-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 22, 2023

Date Posted: August 9, 2023

Recall Number: Z-2285-2023

Event ID: 92682

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.

Status: Ongoing

Product Quantity: 19 units

Code Information:

UDI-DI: (01)07540196001786 Serial Numbers: 710423E00039 710423E00034 710423E00038 710423E00052 710423E00033 710423E00005 710423E00013 710423E00036 710423E00006 710423E00007 710423E00037 710423E00059 710423E00035 710423E00055 710423E00042 710423E00050 710423E00045 710423E00043 710423E00040

Distribution Pattern:

US Nationwide Distribution and in the country of Canada

Voluntary or Mandated:

Voluntary: Firm initiated