Draeger, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1493-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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

Product Classification:

Class I

Date Initiated: March 12, 2025

Date Posted: April 9, 2025

Recall Number: Z-1493-2025

Event ID: 96342

Reason for Recall:

The potential for cracks forming in the breathing circuit hose.

Status: Ongoing

Product Quantity: 65150 units

Code Information:

Model/Catalog Number: MP00355; UDI Number 04048675248996; All lot numbers

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

Voluntary or Mandated:

Voluntary: Firm initiated