Changeflow GovPing Healthcare Olympus Biopsy Valve Recall - Rubber Fragment D...
Urgent Enforcement Removed Final

Olympus Biopsy Valve Recall - Rubber Fragment Detachment

Favicon for changeflow.com FDA: Device Recalls Class II
Filed March 11th, 2026
Detected March 29th, 2026
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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

  1. Review inventory for Olympus Single Use Biopsy Valves, Model MAJ-210.
  2. Follow FDA and manufacturer guidelines for handling and reporting recalled devices.
  3. 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

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
March 11th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Z-1488-2026

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical Device Recalls
Geographic scope
United States US

Taxonomy

Primary area
Product Safety
Operational domain
Compliance
Topics
Medical Devices Healthcare

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