Draeger ErgoStar Catheter Mounts Recalled for Cracks in the Hose

Agency Publication Date: December 8, 2025

Summary

Draeger, Inc. is recalling 326,790 units of ErgoStar CM catheter mounts because cracks can form in the hose. The recall affects models CM 40, CM 45, CM 55, and CM 60, which are airway connectors used to deliver respiratory gases to mechanically ventilated patients. Multiple complaints have been reported regarding cracks forming in these specific mounts.

Risk

Cracks in the breathing hose can cause gas leaks, which may prevent the patient from receiving enough oxygen or proper ventilation during mechanical breathing support.

What You Should Do

This recall affects Draeger ErgoStar CM 40, CM 45, CM 55, and CM 60 catheter mounts with catalog numbers MP01840, MP01845, MP01855, and MP01860. All lot numbers for these models are included in the recall.
Stop using the recalled devices immediately to prevent potential system leaks and patient harm.
Contact Draeger, Inc. or your equipment distributor to arrange for the return, replacement, or correction of the affected units.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional information about this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: ErgoStar CM 40

Model / REF:

MP01840

Lot Numbers:

All lot numbers

UDI:

04048675420736

Recall #: Z-0590-2026

Product: ErgoStar CM 45

Model / REF:

MP01845

Lot Numbers:

All lot numbers

UDI:

04048675420729

Recall #: Z-0591-2026

Product: ErgoStar CM 55

Model / REF:

MP01855

Lot Numbers:

All lot numbers

UDI:

04048675420705

Recall #: Z-0592-2026

Product: ErgoStar CM 60

Model / REF:

MP01860

Lot Numbers:

All lot numbers

UDI:

04048675420699

Recall #: Z-0593-2026

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97923

Status: Active

Manufacturer: Draeger, Inc.

Sold By: Medical device distributors

Manufactured In: United States

Units Affected: 4 products (14420 units; 191470 units; 118850 units; 2050 units)

Distributed To: California, Florida, Illinois, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Draeger ErgoStar CM 40, CM 45, CM 55, and CM 60 catheter mounts with catalog numbers MP01840, MP01845, MP01855, and MP01860. All lot numbers for these models are included in the recall.

Stop using the recalled devices immediately to prevent potential system leaks and patient harm.

Contact Draeger, Inc. or your equipment distributor to arrange for the return, replacement, or correction of the affected units.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional information about this recall.

Affected Products

Product: ErgoStar CM 40

Model / REF:

MP01840

Lot Numbers:

All lot numbers

UDI:

04048675420736

Recall #: Z-0590-2026

Product: ErgoStar CM 45

Model / REF:

MP01845

Lot Numbers:

All lot numbers

UDI:

04048675420729

Recall #: Z-0591-2026

Product: ErgoStar CM 55

Model / REF:

MP01855

Lot Numbers:

All lot numbers

UDI:

04048675420705

Recall #: Z-0592-2026

Product: ErgoStar CM 60

Model / REF:

MP01860

Lot Numbers:

All lot numbers

UDI:

04048675420699

Recall #: Z-0593-2026

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97923

Status: Active

Manufacturer: Draeger, Inc.

Sold By: Medical device distributors

Manufactured In: United States

Units Affected: 4 products (14420 units; 191470 units; 118850 units; 2050 units)

Distributed To: California, Florida, Illinois, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Wisconsin