HIGH

Draeger Recalls Airway Connector Over Cracking Hazard

Draeger recalled 118,850 airway connectors on November 10, 2025, due to cracking hazards. This recall affects multiple countries, including the United States and Australia. The device poses a serious risk to mechanically ventilated patients.

Quick Facts at a Glance

Recall Date
November 10, 2025
Hazard Level
HIGH
Brand
Draeger
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
10 states
At-Risk Groups
GENERAL

Hazard Information

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Draeger, Inc. or your healthcare provider for instructions. Notification method: Letter

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About This Product

The ErgoStar CM 55 is an airway connector used in mechanical ventilation to conduct respiratory gases. Healthcare providers typically use this device for patients requiring respiratory assistance.

Why This Is Dangerous

Cracks in the hose can compromise the integrity of gas delivery, leading to potential respiratory distress for patients. This defect could result in inadequate ventilation during critical care situations.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall requires immediate cessation of use, potentially impacting patient care and requiring alternative solutions for healthcare providers.

Practical Guidance

How to identify if yours is affected

  1. Check for the model number MP01855 on the airway connector.
  2. Inspect the hose for any visible cracks or damage.
  3. Refer to the recall letter from Draeger, Inc. for further instructions.

Where to find product info

The model number and UDI can typically be found printed on the device packaging or on the connector itself.

What timeline to expect

Refund processing may take 4-8 weeks after the recall submission is completed.

If the manufacturer is unresponsive

  • Document all communication attempts with Draeger, Inc.
  • Reach out to the FDA if the company remains unresponsive to your inquiries.
  • Consider seeking legal advice for unresolved issues.

How to prevent similar issues

  • Always check for product recalls before use of medical devices.
  • Ensure that devices are inspected regularly for any signs of wear or damage.
  • Educate healthcare staff on identifying potential hazards associated with medical equipment.

Documentation advice

Keep all records of communications, receipts, and photos of the product, including any damage, for your reference.

Product Details

The recalled product is the ErgoStar CM 55, Model/Catalog Number: MP01855. It was distributed worldwide, including states like California, Florida, and New York. The device is used for conducting respiratory gases between the breathing system and patient interface.

Key Facts

  • Model: ErgoStar CM 55, MP01855
  • Quantity recalled: 118,850 units
  • Distribution: Worldwide
  • Hazard classification: Class I
  • Immediate action required from users

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Brand
Model Numbers
Model/Catalog Number: MP01855
UDI Number: 04048675420705
Lot numbers: All lot numbers
Affected States
CA, FL, IL, NY, OH, OK, PA, SC, TX, WI
Report Date
December 17, 2025
Recall Status
ACTIVE

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