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.
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 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
- Hazard
- protective-adhesive-missing
- equipment-malfunction
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.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03