Device recall

Z-1686-2024: Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number…

FDA device recall · Class II · Electro Medical Systems SA

Key facts

Recall number (Z-number) Z-1686-2024
Recall event 94293
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…
Product code ELC
Recalling firm Electro Medical Systems SA
Recall class Class II
Status Open, Classified
510(k) numbers K190124
FEI number 3002806910

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)