Home › Device types › FLE
Sterilizer, Steam
FDA product code FLE · Class 2 · General Hospital
1,327
Registered devices
1,502
Adverse events
18
Recalls
185
510(k) clearances
Devices with this code
Amsco — Steris Mexico, S. de R.L. de C.V.AESCULAP — Aesculap AGGetinge 400 Series — GETINGE IC PRODUCTION POLAND SP Z O OAMSCO — Steris Mexico, S. de R.L. de C.V.AESCULAP — Aesculap AGAMSCO — Steris Mexico, S. de R.L. de C.V.AMSCO — Steris Mexico, S. de R.L. de C.V.Getinge 600 Series — GETINGE IC PRODUCTION POLAND SP Z O OGetinge 500 Series — GETINGE IC PRODUCTION POLAND SP Z O OAMSCO — Steris Mexico, S. de R.L. de C.V.Getinge 600 Series — GETINGE IC PRODUCTION POLAND SP Z O OSTATCLAVE G4 Chamber Autoclave — Dent4You AGGetinge 500 Series — GETINGE IC PRODUCTION POLAND SP Z O OGetinge 700 Series — GETINGE IC PRODUCTION POLAND SP Z O OAMSCO — Steris Mexico, S. de R.L. de C.V.Midmark — MIDMARK CORPORATIONNA — FORT DEFIANCE INDUSTRIES, LLCGetinge 500 Series — GETINGE IC PRODUCTION POLAND SP Z O OEnbio PRO (ver. USA/CAN) — Enbio Group AGAMSCO — Steris Mexico, S. de R.L. de C.V.Getinge 800 Series — GETINGE IC PRODUCTION POLAND SP Z O OSTATCLAVE G4 Chamber Autoclave — Dent4You AGPRIMUS Sterilizer — Primus Sterilizer Company, LLCAMSCO — Steris Mexico, S. de R.L. de C.V.
Recent 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 resul |
| 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 mean |
| 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 mean |
| 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 tran |
| 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 c |
| 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 |
| 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 |
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