STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended… — Class II medical device recall Z-2286-2023
Ongoing recall by Scican Ltd., reported 2023-08-09, distributed nationwide. The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health c
| Recall number | Z-2286-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Scican Ltd., North York, N/A, Canada |
| Recall initiated | 2023-06-22 |
| Classified | 2023-08-02 |
| Reported by FDA | 2023-08-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 3 units |
| UPC / GTIN / UDI-DI | 07540196001793 |
| Serial numbers | 710523E00005, 710523E00006, 710523E00007 |
| Model numbers | 622303 |
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 622303
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2286-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.