Z-2285-2023Class II

STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to...

Name: Z-2285-2023 STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to...
Creator: Scican Ltd.
Published: 2023-06-22
License: https://open.fda.gov/license/

Scican Ltd. / initiated 2023-06-22 / Open, Classified / root cause: manufacturing process

FDA source

Scican Ltd. began a recall of STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized... on 2023-06-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2285-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-22
Posted: 2023-08-03
Recalling firm: Scican Ltd.
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
Product code: FLE Sterilizer, Steam
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: SciCan Ltd issued Urgent Medical Device Recall Letter to Distributors on June 22, 2023. via email. Letter states reason for recall, health risk and action to take: " Please immediately reach out to any customers (end users of the autoclave) who have received an affected unit and inform them that they must stop using their unit until it has been checked and, if needed, the gaskets have been installed (please see the last page of this notification for a list of serial numbers affected that were delivered to your organization). From the information received from you, requested in the next step below, our sales representatives will be visiting the location of any affected unit to confirm if the gaskets are missing. " Please immediately complete the MEDICAL DEVICE RECALL RETURN RESPONSE, Acknowledgement and Receipt Form included as the last page of this notice. After all information has been completed, sign and return the form to Israa Howlader, copy Stacey Graf, Rich Strader and Teresa Boyce (their contact information is included on the form). " Please also indicate on the attached Acknowledgement and Receipt form that you have received and understood this correction notice. If you have further questions about the product or the recall, please immediately contact Teresa Boyce [email protected], Stacey Graf at [email protected] or Rich Strader [email protected]. " Once we receive your completed Acknowledgement and Receipt form, we will arrange for one of our sales representatives to visit your customer (the end user) or warehouse where the unit is located to confirm if the gaskets are missing from their unit(s). If the gaskets are missing, in order to apply the correction as soon as possible, our sales representatives will immediately provide the gaskets needed so your trained service technician can install them onto the unit. Please see the attached instructions for directions on how to install the gaskets. (For units that are still in your inve
Quantity in commerce: 19 units
Distribution: US Nationwide Distribution and in the country of Canada
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2285-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2285-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-02
Z-2286-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-02

Product code FLE

K190062Class IISTATCLAVE G4 Chamber AutoclaveScican , Ltd. / cleared 2019-07-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)