Pentax of America Inc: Medical Device Recall in 2021 - (Recall #: Z-2449-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 14, 2021

Date Posted: September 22, 2021

Recall Number: Z-2449-2021

Event ID: 88440

Reason for Recall:

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

Status: Ongoing

Product Quantity: 28849 units Total

Code Information:

All devices distributed by Pentax in the US between April 2014 and May 2021

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated