FDA recall Z-2448-2021

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Ongoing

Initiation date

2021-07-14

Report date

2021-09-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Montvale, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2448-2021