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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Draeger
- Product type
- Airway Connector
- Model numbers
- Model/Catalog Number: MP01855, UDI Number: 04048675420705, Lot numbers: All lot numbers
- Sold at
- Unknown
- Where affected
- CA, FL, IL, NY, OH, OK, PA, SC +2 more
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 10, 2025
Reported by FDA DEVICE
December 17, 2025
RecallRadar source check
December 24, 2025
Consumer action
Use the official remedy and keep documentation.
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
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
- Check for the model number MP01855 on the airway connector.
- Inspect the hose for any visible cracks or damage.
- 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.
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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
- Hazard classification: Class I
- Immediate action required from users
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