ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the b
Summary
The FDA issued a Class I for ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for condu by Draeger, Inc.. Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts..
Details
Source
Device Recall
External ID
Z-0591-2026
Action Date
2025-12-17
Status
Ongoing
Category
device
Product Description
ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
Lot/Code Info: Model/Catalog Number: MP01845; UDI Number: 04048675420729; Lot numbers: All lot numbers;
Quantity Affected: 191470 units
Reason for Recall
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
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, Germany, Hungary, Indonesia, Italy, Japan, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkiye, Ukraine, and United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-10
Company
Telford, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 244 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Draeger, Inc. has 21 FDA actions in our database, including 21 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Draeger, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Draeger, Inc. have FDA actions?
Draeger, Inc. has 21 FDA actions in our database, including 21 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0591-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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