PENTAX OF-B121Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04961333070442), received between Jan 31, 2023 and Jan 31, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Eject” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K963056); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2023Unintended Movement; Failure to Eject; Unintended Movement; Failure to Eject

  THE VALVE IS DEFECTIVE SO THE VALVE CONSTANTLY INSUFFLATES AIR. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16275390 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963056. One submission often covers many models, so check the product and lot details in each record.

• Z-2713-2017 · Jan 17, 2017 · Terminated
  Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. T
• Z-2277-2016 · Apr 6, 2016 · Terminated
  Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the