# FDA recall Z-2148-2019

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2019-04-01.

## Product

Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209    Product Usage:  This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

## Reason for recall

There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.

## Distribution

The products were distributed US Nationwide.

## Key facts

- **Recall number:** Z-2148-2019
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-01
- **Report date:** 2019-08-14
- **Termination date:** 2020-06-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2148-2019

## Citation

> AI Analytics. FDA recall Z-2148-2019. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-2148-2019. Source: US FDA. Licensed CC0.

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