STATCLAVE G4 Medical Sterilizer Recalled for Incomplete Sterilization Risk
FDA recalls 19 units of the STATCLAVE G4 steam sterilizer (Class II). The device may result in incomplete sterilization when used with incompatible materials.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for a critical sterilization system where processing incompatible materials may result in incomplete sterilization. Although no reported illnesses or injuries are documented in the source, incomplete sterilization of medical instruments represents a significant risk of harm in healthcare settings. This qualifies as a High-severity risk-of-harm product where injury has not yet been reported.
Plain-English summary
Scican Ltd. is recalling 19 units of the STATCLAVE G4 Chamber Autoclave, a tabletop steam sterilizer used in healthcare settings to sterilize dental and medical instruments using pressurized steam. The affected units have been distributed nationwide in the United States and in Canada.
The STATCLAVE G4 is designed specifically for sterilizing instruments validated for steam sterilization and is not intended for use with liquid loads, biomedical waste, or materials incompatible with steam sterilization. Processing such incompatible materials in the device may result in incomplete sterilization of instruments and/or damage to the autoclave itself.
Healthcare providers should verify whether they operate any of the recalled units by checking the provided serial numbers. Facilities with affected equipment should ensure the sterilizer is used only with validated, steam-compatible loads to maintain proper sterilization of medical instruments.
The recalled product
- 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
- Manufacturer
- Scican Ltd.
- Hazard
- incomplete-sterilization
Distribution
Distributed nationwide across the United States.
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