Quick Facts at a Glance
- Recall Date
- November 10, 2025
- Hazard Level
- HIGH
- Brand
- Draeger
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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: MP01860, UDI Number: 04048675420699, Lot numbers: All lot numbers
- Sold at
- Multiple Retailers
- 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 60 is an airway connector used in healthcare settings to facilitate the conduction of respiratory gases. It is typically employed in the care of mechanically ventilated patients, ensuring effective gas exchange during treatment.
Why This Is Dangerous
The product may develop cracks in the hose, which can interfere with proper ventilation and pose a risk to patient safety. Such defects can lead to inadequate delivery of oxygen or other gases during mechanical ventilation.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause significant disruption for healthcare providers relying on this equipment. Immediate action is required to ensure patient safety, which may lead to temporary shortages of alternative devices.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the product, which is MP01860.
- Check the packaging or device itself for the recall notification.
- Confirm whether your device has been identified in the recall.
Where to find product info
Look for the model number on the connector's body or packaging, typically printed or engraved on the device.
What timeline to expect
Expect a response regarding refunds or replacements within 4-6 weeks after contacting Draeger, Inc.
If the manufacturer is unresponsive
- Document your correspondence with Draeger, Inc.
- Follow up with a phone call if you do not receive a timely response.
- Consider contacting relevant health authorities if issues persist.
How to prevent similar issues
- Check for recalls regularly on medical devices before use.
- Ensure that alternative devices are available as backups.
- Consult with healthcare providers about the safest equipment options.
Documentation advice
Keep a record of your purchase information, correspondence with the manufacturer, and any receipts related to the recalled product.
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Product Details
The recalled product is the ErgoStar CM 60, Model/Catalog Number MP01860. It connects respiratory gases between the breathing system and patient interface, such as an endotracheal tube. The product was distributed worldwide, including several U.S. states.
Key Facts
- Recall date: November 10, 2025
- Quantity recalled: 2,050 units
- Class I recall indicating high risk
- Worldwide distribution including U.S. states CA, FL, IL, NY, TX
- Contact Draeger, Inc. for instructions
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Safety Guide
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