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Enbio PRO (ver. USA/CAN)
Enbio Group AG · Model Enbio PRO (ver. USA/CAN) · UDI-DI 07629999900769
10
510(k) clearances
1,502
Adverse events (1 deaths)
18
Recalls
61
Facilities
Description
The Enbio PRO is an air-removal (pre-vacuum) table-top 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 Enbio PRO has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-08 | Fort Defiance Industries, LLC | The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable f |
| 2023-06-22 | Scican Ltd. | 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 ste |
| 2023-06-22 | Scican Ltd. | 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 ste |
| 2021-08-19 | Fort Defiance Industries, LLC | The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground. |
| 2019-10-22 | Steris Corporation | Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers. |
| 2019-10-22 | Steris Corporation | The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the transfer carriage and lo |
| 2019-04-18 | Skytron, Div. The KMW Group, Inc | Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure |
| 2018-12-26 | Steris Corporation | The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in the loading car unexpectedly slid |
| 2018-05-24 | Fort Defiance Industries, LLC | During long-term storage (i.e. military depot), the interaction of stagnant water and dissimilar metals in the plumbing of the P2131 device produces deposits in the water system th |
| 2015-09-03 | Steris Corporation | In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.