Olympus Colonoscope Recall: Missing Protective Adhesive in 47 Units
Olympus is recalling 47 colonoscope units (Model PCF-H190DL) because they were assembled without protective adhesive. The missing adhesive may cause equipment failure 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 FDA recall of a medical device with no reported injuries or hospitalizations. The structural assembly defect in a risk-of-harm product where injury has not yet been reported meets the rubric criteria for severity score 3 (High).
Plain-English summary
Olympus Corporation of the Americas is recalling 47 colonoscope units, Model Number PCF-H190DL, due to a manufacturing assembly defect. Certain colonoscopes from this model were assembled without a protective adhesive component.
A protective adhesive normally shields the colonoscope from certain physical conditions, including high levels of vibration, fluctuations in temperature, and severe shock loads. The affected units lack this protective component.
The recall affects colonoscopes distributed nationwide in the United States. All 47 affected units have been identified by specific serial number. This is a Class II recall issued by the Food and Drug Administration.
The recalled product
- Product
- Colonoscope, Model Number PCF-H190DL.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device
- Hazard
- structural-defect
- equipment-failure
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-H190DL
- UDI DI: 04953170363672
- Serial Number: 2046148
- 2046377
- 2500549
- 2501714
- 2602501
- 2602549
- 2602675
- 2602884
- 2603086
- 2605185
- 2605189
- 2605279
- 2605338
- 2605343
- 2615621
- 2716237
- 2716306
- 2716379
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- 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 Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03