Colonoscope Model PCF-Q180AL Recalled Due to Missing Protective Adhesive
Olympus Corporation of the Americas is recalling Colonoscope Model PCF-Q180AL units that were assembled without protective adhesive. This missing adhesive protects the device from vibration, temperature fluctuations, and physical shock during use.
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 recall for a structural assembly defect in a medical device used for invasive procedures. The missing protective adhesive represents a potential risk of device malfunction during clinical use, and this meets the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling certain Colonoscope Model PCF-Q180AL units that were assembled without protective adhesive. Four specific units with serial numbers 2200140, 2603268, 2808983, and 2909332 are included in this recall.
The protective adhesive is designed to protect the device from certain physical conditions during use, including high levels of vibration, temperature fluctuations, and severe shock loads. Without this adhesive, the colonoscope may not function properly under these operational conditions.
The affected units were distributed nationwide throughout the United States. The device model number PCF-Q180AL (UDI DI: 4953170307720) can be used to identify affected units.
Healthcare facilities or individuals who own or operate one of these recalled colonoscopes should contact Olympus Corporation of the Americas for information about repair or replacement options.
The recalled product
- Product
- Colonoscope, Model Number PCF-Q180AL.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device
- Affected units
- 4
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 (6)
- Model Number: PCF-Q180AL
- UDI DI: 4953170307720
- Serial Number: 2200140
- 2603268
- 2808983
- 2909332
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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