Colonoscope Model PCF-H190L Recalled for Missing Protective Adhesive
Olympus Corporation recalled 31 colonoscopes lacking a protective adhesive that shields against vibration, temperature fluctuations, and shock. The missing adhesive may affect device structural integrity under physical stress.
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 recall of a medical device with a structural defect (missing protective adhesive). Although no injuries or illnesses have been reported, the defect creates a risk-of-harm situation where device malfunction is possible under physical stress conditions.
Plain-English summary
Olympus Corporation of the Americas recalled 31 Colonoscope Model PCF-H190L units distributed nationwide. The affected units are specific repaired colonoscopes that were assembled without a protective adhesive designed to shield the device from physical stress.
The missing adhesive normally protects against high levels of vibration, temperature fluctuations, and severe shock loads. Without it, the colonoscopes may not maintain their intended structural integrity or function reliably under these conditions.
Affected medical facilities should verify whether they received any of the 31 units with the affected serial numbers and contact Olympus Corporation of the Americas for further instructions.
The recalled product
- Product
- Colonoscope, Model Number PCF-H190L.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Hazard
- structural-defect
- malfunction-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 (20)
- Model Number: PCF-H190L
- UDI DI: 04953170305191
- Serial Number: 2201678
- 2201735
- 2301759
- 2301775
- 2301929
- 2301930
- 2302159
- 2302280
- 2302281
- 2302380
- 2302506
- 2303832
- 2303927
- 2404124
- 2404132
- 2404806
- 2404888
- 2404967
Distribution
Distributed nationwide across the United States.
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