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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Category
- Medical Device — Endoscopy
- Affected units
- 2
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.
Part of a larger recall action
This product is one of 10 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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