The Recall Desk
HighFDA (Devices)·Z-1208-2024·Announced 2024-03-06

Colonoscope Model CF-Q180AL Recalled Due to Missing Protective Adhesive

Olympus is recalling two colonoscopes (Model CF-Q180AL, serial numbers 2602060 and 2603763) due to missing protective adhesive that normally guards against vibration, temperature changes, and shock loads.

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: This is an FDA Class II medical device recall. No illnesses or injuries have been reported, but the hazard is a manufacturing defect (missing protective adhesive) that could compromise device integrity. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

Olympus Corporation of the Americas is recalling two units of the Colonoscope, Model Number CF-Q180AL (serial numbers 2602060 and 2603763). These devices were repaired and reassembled without a protective adhesive that normally guards against vibration, temperature fluctuations, and severe shock loads.

The affected colonoscopes were distributed nationwide in the United States. Without the protective adhesive, these devices may not maintain their integrity when exposed to the physical stressors they were designed to withstand.

The recalled product

Product
Colonoscope, Model Number CF-Q180AL.
Manufacturer
Olympus Corporation of the Americas
Hazard
  • structural-defect
  • manufacturing-defect

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 (4)

  • Model Number: CF-Q180AL
  • UDI DI: 04953170307706
  • Serial Number: 2602060
  • 2603763

Distribution

Distributed nationwide across the United States.