Draeger, Inc. medical device recall: Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96342
- Recall initiated
- Mar 12, 2025
- Classified by FDA
- Apr 3, 2025
- Posted in Enforcement Report
- Apr 9, 2025
- Recalling firm
- Draeger, Inc.
- Firm location
- Telford, PA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 7
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
The potential for cracks forming in the breathing circuit hose.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Mar 12, 2025. FDA classified it 22 days later, on Apr 3, 2025. This recall event covers 7 separate products, each with its own FDA recall number. Distribution reported by FDA: 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 Draeger, Inc. has 7 recalls in our records.
Recalled products (7)
Z-1493-2025 Class I Ongoing
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
Codes / lots: Model/Catalog Number: MP00355; UDI Number 04048675248996; All lot numbers
Quantity: 65150 units
Z-1494-2025 Class I Ongoing
Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult Component: Not applicable
Codes / lots: Model/Catalog Number: MP01347; UDI Number 04048675249337; All lot numbers.
Quantity: 3325 units
Z-1495-2025 Class I Ongoing
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
Codes / lots: Model/Catalog Number: MP02737; UDI Number 04048675389620; All lot numbers.
Quantity: 3140
Z-1496-2025 Class I Ongoing
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
Codes / lots: Model/Catalog Number: MP02738; UDI Number 04048675389637; All lot numbers.
Quantity: 780 units
Z-1497-2025 Class I Ongoing
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only
Codes / lots: Model/Catalog Number: MP02744; UDI Number 040486775389675; All lot numbers.
Quantity: 293660 units
Z-1498-2025 Class I Ongoing
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
Codes / lots: Model/Catalog Number: MP02752; UDI Number 04048675389729; All lot numbers.
Quantity: 9250 units
Z-1499-2025 Class I Ongoing
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only
Codes / lots: Model/Catalog Number: MP17103; UDI Number 04048675695660; All lot numbers.
Quantity: 13620 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 96342
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.