Olympus colonovideoscope recalled for potential microbial contamination from veterinary use
An Olympus EVIS EXERA III colonovideoscope was used in veterinary endoscopy before being designated as a medical facility loaner, creating potential for microbial contamination.
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 risk-of-harm product (invasive medical device) where the hazard is potential microbial contamination, but no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
Olympus Corporation of the Americas is recalling a single EVIS EXERA III colonovideoscope (Model CF-Q180AL). This medical device is used for endoscopy and endoscopic surgery within the lower digestive tract.
A single unit was used in a veterinary endoscopy procedure before being assigned to a medical facility as a service loaner in error. This improper use creates potential for microbial contamination.
The recalled unit was distributed in the United States, with documented distribution in the states of California, Florida, Georgia, New York, Oregon, and Virginia.
The recalled product
- Product
- EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 1
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 (1)
- UDI: 04953170202315 Serial number 2807443
Distribution
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