Colonoscope Model CF-HQ190L Recalled Due to Missing Protective Adhesive
Olympus Corporation is recalling 97 Colonoscope Model CF-HQ190L units distributed nationwide. The devices were assembled without protective adhesive, risking malfunction under vibration, temperature changes, or shock.
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 a Class II recall of a medical device with a structural defect—missing protective adhesive—that could cause malfunction under stress conditions. No illnesses or injuries have been reported, making it a risk-of-harm product without yet-reported injury.
Plain-English summary
Olympus Corporation of the Americas is recalling 97 units of the Colonoscope Model CF-HQ190L that were assembled without protective adhesive. These units were distributed nationwide in the United States.
The missing adhesive is designed to protect the colonoscope from certain physical conditions, including high levels of vibration, temperature fluctuations, and severe shock loads. Without this protection, the device may malfunction or fail to perform as intended during clinical use.
Healthcare facilities and clinics using these devices should immediately verify whether their colonoscopes match the recalled serial numbers. If a match is identified, the affected devices should be removed from service until replacement or repair options can be arranged through Olympus Corporation.
The recalled product
- Product
- Colonoscope, Model Number CF-HQ190L.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Affected units
- 97
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 (20)
- Model Number: CF-HQ190L
- UDI DI: 04953170305115
- Serial Number: 2082724
- 2082896
- 2082936
- 2083461
- 2083765
- 2084560
- 2085050
- 2186261
- 2187110
- 2187274
- 2187811
- 2188037
- 2188206
- 2200530
- 2201625
- 2201677
- 2201844
- 2202345
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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