Draeger, Inc.: Device Recall

Recall #Z-1493-2025 · 03/12/2025

Class I: Dangerous

Recall Details

Recall Number
Z-1493-2025
Classification
Class I
Product Type
Device
Recalling Firm
Draeger, Inc.
Status
Ongoing
Date Initiated
03/12/2025
Location
Telford, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
65150 units

Reason for Recall

The potential for cracks forming in the breathing circuit hose.

Product Description

Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult patients. The breathing circuit is intended for single use only. Component: Not applicable

Distribution Pattern

Domestic: Nationwide Distribution. International - following countries: Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy, Japan, Panama, Philippines, Portugal, Singapore, South Africa, Spain, Sweden, United Kingdom

Other Recalls by Draeger, Inc.

View all recalls by Draeger, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.