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AESCULAP

Aesculap AG · Model JK785 · UDI-DI 04038653294367

FLE
10
510(k) clearances
1,502
Adverse events (1 deaths)
18
Recalls
61
Facilities

Description

Inner Lid, basis, Standard 3/4, red, outer length: 465 mm, outer width: 285 mm, outer heigth: 36 mm

Recalls

DateFirmReason
2026-07-08Fort Defiance Industries, LLCThe 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
2023-06-22Scican 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
2023-06-22Scican 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
2021-08-19Fort Defiance Industries, LLCThe rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.
2019-10-22Steris CorporationPotential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers.
2019-10-22Steris CorporationThe 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
2019-04-18Skytron, Div. The KMW Group, IncWeld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure
2018-12-26Steris CorporationThe 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
2018-05-24Fort Defiance Industries, LLCDuring 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
2015-09-03Steris CorporationIn 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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Data 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.