Colonoscope Model PCF-HQ190L Recalled for Missing Protective Adhesive
Olympus is recalling 28 colonoscopes (Model PCF-HQ190L) due to missing adhesive that protects the device from vibration, temperature changes, and physical shock. The defect could cause device malfunction during procedures.
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: FDA Class II medical device with a structural defect (missing protective adhesive) that could impair function during use. No illnesses or injuries have been reported to date.
Plain-English summary
Olympus Corporation of the Americas is recalling 28 colonoscopes, Model Number PCF-HQ190L, distributed nationwide in the United States.
The recalled colonoscopes were repaired and assembled without a protective adhesive that shields the device from physical stresses including high levels of vibration, temperature fluctuations, and severe shock loads. Without this adhesive, the device may not function correctly during use.
No illnesses or injuries have been reported related to this defect.
The recalled product
- Product
- Colonoscope, Model Number PCF-HQ190L.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Affected units
- 28
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-HQ190L
- UDI DI: 4953170416118
- Serial Number: 2000569
- 2001007
- 2101185
- 2101301
- 2101313
- 2101860
- 2102339
- 2102634
- 2102740
- 2103215
- 2103257
- 2103483
- 2103614
- 2103674
- 2203899
- 2203915
- 2204096
- 2204400
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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