Pentax of America Inc: Medical Device Recall in 2021 - (Recall #: Z-2448-2021)

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:

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

Product Classification:

Class II

Date Initiated: July 14, 2021

Date Posted: September 22, 2021

Recall Number: Z-2448-2021

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