medical Class II Updated 2021-09-22

Pentax of America Inc recalls Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family)

Recalled Product

Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK

Hazard / Issue

Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All devices distributed by Pentax in the US between April 2014 and May 2021
View official government recall

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