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.
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 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
- Affected units
- 47
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.
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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