FDA recall Z-2449-2021

Product

Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK

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-2449-2021