Olympus Biopsy Valve Recall - Rubber Fragment Detachment
Summary
The FDA has initiated a Class II recall for Olympus Single Use Biopsy Valves (Model MAJ-210) due to the potential for rubber fragments to detach during use. The recall impacts nationwide distribution in the US.
What changed
The FDA has classified a recall of Olympus Single Use Biopsy Valves, Model MAJ-210, as Class II. The reason for the recall is the potential for rubber fragments to detach during use, which could pose a risk to patients. The product was distributed nationwide in the US.
Healthcare providers and medical device distributors who have these valves in stock should be aware of this recall and follow appropriate procedures for handling and reporting. While no specific compliance deadline is mentioned, prompt action is expected to mitigate patient risk. This recall signifies a potential product defect that requires immediate attention from entities involved in the supply chain and clinical use of this device.
What to do next
- Review inventory for Olympus Single Use Biopsy Valves, Model MAJ-210.
- Follow FDA and manufacturer guidelines for handling and reporting recalled devices.
- Notify relevant clinical staff and potentially affected patients.
Source document (simplified)
Olympus Corporation of the Americas
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1488-2026 · 20260311 · Ongoing
Product
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent ...
Reason for Recall
Potential for rubber fragment detachment during use.
Distribution
US Nationwide distribution.
Source: openFDA Enforcement API
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