The Recall Desk
HighFDA (Devices)·Z-0334-2024·Announced 2023-11-29

Gastrointestinal videoscopes recalled due to unvalidated channel drying process

Aizu Olympus is recalling 3,627 gastrointestinal videoscopes because the channel air drying process was not validated. A small percentage of devices returned after repair had wet channels, creating potential for contamination and risk of infection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with no reported illnesses or injuries, but water contamination in invasive-use endoscopes constitutes a risk-of-harm product meeting the High-severity criterion per the rubric.

Plain-English summary

Aizu Olympus Co., Ltd. is recalling 3,627 gastrointestinal videoscopes used for examination of the upper digestive tract, including the esophagus, stomach, and duodenum. The recall affects multiple model numbers distributed worldwide and throughout the United States.

The channel air drying process for these endoscopes was not validated. As a result, a small percentage of devices returned to customers after repair had water remaining in the channel. Water remaining in the channel has the potential for contamination that could lead to risk of infection.

Healthcare facilities and medical practitioners who use these Olympus endoscope models are affected by this recall. The FDA classified this as a Class II recall.

The recalled product

Product
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q16
Manufacturer
Aizu Olympus Co., Ltd.
Category
Medical Device — Gastrointestinal Endoscope
Hazard
  • water-contamination
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • Model Numbers: GIF-1TH190 (04953170343360)
  • GIF-1TQ160 (Not recorded)
  • GIF-2T160 (04953170307492)
  • GIF-2TH180 (04953170339745)
  • GIF-H170 (04953170334115)
  • GIF-H180 (04953170339769)
  • GIF-H180J (04953170307539)
  • GIF-H190 (04953170305290)
  • GIF-HQ190 (04953170305276)
  • GIF-LV1 (04953170312373)
  • GIF-N180 (04953170307508)
  • GIF-Q150 (04953170307485)
  • GIF-Q160Z (04953170066795)
  • GIF-Q180 (04953170307522)
  • GIF-XP180N (04953170307515)
  • GIF-XP190N (04953170305313)
  • GIF-XTQ160 (04953170339837).

Distribution

Distributed nationwide across the United States.

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