The Recall Desk
SevereFDA (Devices)·Z-1493-2025·Announced 2025-04-09

VentStar Flex 220 Breathing Circuit Recalled for Potential Hose Cracks

Draeger, Inc. is recalling 65,150 units of the VentStar Flex 220 breathing circuit due to the potential for cracks to form in the hose. A crack could affect gas delivery during anesthesia or ventilation procedures.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification establishes a minimum severity of 4. While no deaths or reported injuries are documented in the source, the agency determined the potential for serious adverse health consequences from a structural defect in a critical medical device used during anesthesia and ventilation.

Plain-English summary

The VentStar Flex 220 breathing circuit (Model MP00355), manufactured by Draeger, Inc., is being recalled due to the potential for cracks to form in the breathing circuit hose. This device is used to convey breathing gases between an anesthesia machine or ventilator and adult patients.

A crack in the breathing circuit hose could affect the delivery of breathing gases during anesthesia or ventilation procedures. The FDA classified this as a Class I recall due to the serious potential impact on patient safety.

Approximately 65,150 units have been distributed nationwide in the United States and to 21 other countries. All lot numbers of Model MP00355 (UDI Number 04048675248996) are affected.

The recalled product

Product
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 in
Manufacturer
Draeger, Inc.
Category
Medical Device — Anesthesia Equipment
Hazard
Affected units
65,150

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Draeger, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

Same manufacturer · Draeger, Inc.

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Same hazard · hose crack

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