Generic Name: Washer-disinfector For Flexible Endoscopes — Trade Name: Efewd Benchtop Endoscope Washer-disinfector

Recall Summary The EFEWD Benchtop Endoscope Washer-Disinfector is being recalled because a kinked tube can prevent the enzymatic cleaning agent from dispensing properly, which may reduce the effectiveness of the disinfection process. The recall affects 222 units manufactured between January 2023 and October 2024, produced by Daiichi Medical Co., Ltd. No health injuries have been reported, and the manufacturer notes that users are instructed to perform manual pre-cleaning before using the device.

Recalling firm

Name of Manufacturer and Distributor: Daiichi Medical Co., Ltd. — Address of Manufacturer and Distributor: 2-27-16 Hongo, Bunkyo-ku, Tokyo — Type of License: Class I Medical Device Manufacturer...

Product

Lot: 対象製造番号 69001、69002、69003、69004、69005、69007、69008、69009、 69010、69011、69012、69013、69014、69015、69016、69017、 69018、69019、69020、69021、69022、69023、69024、69025、 69026、69027、69028、69029、69030、69031、69032、69033、 69034、69035、69036、69037、69038、69039、69040、69042、 69043、69044、69045、69046、69047、69048、69049、69050、 69051、69052、69053、69054、69055、69056、69057、69058、 69059、69060、69061、69062、69063、69064、69065、69066、 69067、69068、69069、69070、69071、69072、69073、69074、 69075、69076、69077、69078、69079、69080、69081、69082、 69083、69084、69085、69086、69087、69088、69089、69090、...

Reason

This device is used to clean and disinfect endoscopes. After removing proteins using an enzymatic cleaning agent, the device performs immersion disinfection using a disinfectant. We have confirmed several instances where the enzymatic cleaning agent was not dispensed properly due to the tube used to inject the agent into the device kinking (buckling). Since this malfunction may prevent the cleaning process from operating normally, we are implementing a voluntary recall.

Classification

Class II

Category

medical device recall

Country

Japan

Agency

PMDA-DEVICE

Status

Ongoing

Official recall notice from PMDA-DEVICE

Recall details on Nibble Recalls: https://trynibble.app/recalls/5f5dfd0b-629d-44ee-bc6d-0a7afaf090b1