Olympus BiCOAG Hemostasis Probe Recalled for Potential Ceramic Tip Detachment
Olympus Corporation of the Americas is recalling 816 units of BiCOAG Hemostasis Probes because the ceramic tip may detach due to insufficient adhesive.
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 is classified as FDA Class II and involves a risk-of-harm product (medical device) where the hazard is potential detachment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Olympus Corporation of the Americas is recalling 816 units of the Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector, Model/Catalog Number CD-B622LA. The recall affects all unexpired lots of this specific model.
The recall was initiated because the probes were manufactured without the designated amount of adhesive, creating a potential for the ceramic tip to detach. This is classified as an FDA Class II recall.
The affected products were distributed worldwide, including the United States, Canada, Latin America, Singapore, Hong Kong, and the European Union. Users should stop using the affected probes and contact Olympus Corporation of the Americas for further instructions.
The recalled product
- Product
- Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 816
Distribution
Distributed nationwide across the United States.
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