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Disinfector, Medical Devices
FDA product code MEC · Class 2 · General Hospital
761
Registered devices
1,315
Adverse events
31
Recalls
2
510(k) clearances
Devices with this code
Sterling P1800 — SKYTRON LLCSterling Washers — SKYTRON LLCSterling P/M1000 Rack — SKYTRON LLCSterling Washers — SKYTRON LLCSterling C2000 — SKYTRON LLCGETINGE 46-SERIES — Getinge Disinfection ABSteelco — STEELCO SPASteelco — STEELCO SPASteelco — STEELCO SPAAMSCO — Corporation Steris CanadaNiagara — MEDISAFE UK LIMITEDReliance Vision — Corporation Steris CanadaAccessory — Getinge Disinfection ABGETINGE 46-SERIES — Getinge Disinfection ABSteelco — STEELCO SPAVision — Corporation Steris CanadaSkytron Moderate Alkaline Detergent — SKYTRON LLCAccessory — Getinge Disinfection ABNA — Corporation Steris CanadaNA — Corporation Steris CanadaAMSCO — Corporation Steris CanadaAMSCO — Corporation Steris CanadaSterling Washers — SKYTRON LLCSterling P/M1000 High speed module — 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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