Olympus BiCOAG Hemostasis Probe Recalled for Ceramic Tip Detachment Risk
Olympus is recalling 2,142 BiCOAG Hemostasis Probes because a manufacturing error may cause the ceramic tip to detach.
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: The recall involves a risk-of-harm medical device where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Olympus Corporation of the Americas is recalling 2,142 units of the Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector, Model CD-B620LA. The recall is due to a manufacturing defect where the probes were produced without the designated amount of adhesive, creating a potential for the ceramic tip to detach.
The affected products were distributed worldwide, including the United States, Canada, Latin America, Singapore, Hong Kong, and the European Union. The recall covers all unexpired lots of the product.
Healthcare professionals should stop using the affected probes and contact Olympus for further instructions. Consumers are not expected to have these medical devices in their possession.
The recalled product
- Product
- Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 2,142
Distribution
Distributed nationwide across the United States.
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