ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathin
FDA device recall Z-0593-2026 · posted 2025-12-08 · Open, Classified
Recall details
- Recalling firm
- Draeger, Inc.
- Reason for recall
- Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
- Action taken
- On November 10, 2025, Urgent Medical Device Recall letters were sent to customers. Necessary Action: Identify if you have any affected product. Do not use any unused ErgoStar CM 40/CM 45/CM 55/CM 60 in your stock. Unused stock should be removed and returned to Draeger. Draeger recommends the alternative product MP01850 ErgoStar CM 50 as a suitable replacement. Please ensure that all potential users in your facility are made aware of this Urgent Medical Device Recall Notice and the information contained herein. If you have forwarded affected products to third parties, please also forward this Urgent Medical Device Recall notification.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- BZA
- Quantity affected
- 2050 units
- Distribution
- Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and WI; Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Ecuador, Finland, France,
- Date initiated
- 2025-11-10
- Date posted
- 2025-12-08
- Location
- Telford, PA
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