# FDA recall Z-1686-2024

> **Electro Medical Systems SA** · Class II · device recall initiated 2024-03-13.

## Product

Brand Name: CLEANER BOTTLE  Product Name: CLEANER BOTTLE  Model/Catalog Number: EG-1000  Software Version: N/A  Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER /  EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning.  Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

## Reason for recall

Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

## Distribution

Worldwide distribution - U.S. Nationwide in the states of IL and TX. The countries of  ALBANIA, ARMENIA, AUSTRALIA, AZERBAIJAN, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, EGYPT, FRANCE, GEORGIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA  REPUBLIC OF, KOSOVO, KUWAIT, LUXEMBOURG, MALAYSIA, MEXICO, MOLDOVA REPUBLIC OF, NETHERLANDS, NEW ZEALAND, OMAN, PALESTINE, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, Thailand, UKRAINE,UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VIETNAM.

## Key facts

- **Recall number:** Z-1686-2024
- **Recalling firm:** Electro Medical Systems SA
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-13
- **Report date:** 2024-05-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Nyon, N/A, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1686-2024

## Citation

> AI Analytics. FDA recall Z-1686-2024. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1686-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*