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Disinfector, Medical Devices
FDA product code MEC · Class 2 · General Hospital
763
Registered devices
1,323
Adverse events
31
Recalls
2
510(k) clearances
Devices with this code
Sterling P1800 — SKYTRON LLCNA — Corporation Steris CanadaAMSCO — Corporation Steris CanadaSteelco — STEELCO SPACleanStart — SKYTRON LLCHYDRIM C61WD G4 Instrument Washer-Disinfector — Scican LtdSterling P1000 Washer Disintector — SKYTRON LLCSterling Washers — SKYTRON LLCSterling P1800 — SKYTRON LLCSteelco — STEELCO SPAMiele — Miele & Cie. KGSterling P/M1000 Basket — SKYTRON LLCNA — Corporation Steris CanadaI-Series Washers — SKYTRON LLCSteelco — STEELCO SPASteelco — STEELCO SPAI-Series Washers — SKYTRON LLCI-Series Washers — SKYTRON LLCSterling Washers — SKYTRON LLCSkytron SCLF Neutral pH Detergent LF 2x Conc. — SKYTRON LLCAccessory — Getinge Disinfection ABSterling P/M1000 Manual loading cart — SKYTRON LLCAccessory — Getinge Disinfection ABSterling P1800 — SKYTRON LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-19 | Steris Corporation | Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within th |
| 2025-11-19 | Steris Corporation | Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within th |
| 2025-08-29 | Getinge Disinfection Ab | Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-press |
| 2025-04-02 | Getinge Disinfection Ab | The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in a |
| 2025-04-02 | Getinge Disinfection Ab | The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in a |
| 2023-04-10 | Steris Corporation | In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malf |
| 2022-04-22 | Steris Corporation | The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the dryin |
| 2022-04-13 | Getinge Usa Sales Inc | Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a cr |
| 2022-04-13 | Getinge Usa Sales Inc | Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a cr |
| 2022-04-01 | Getinge Usa Sales Inc | Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installati |
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