FDA Medical devices recall ·
ErgoStar CM 55, Model recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0592-2026
- Date
- (initiated November 10, 2025)
- Company / brand
- Draeger, Inc.
3135 Quarry Rd, Telford, PA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 118850 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ErgoStar CM 55, Model/Catalog Number: MP01855, 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.
Why was it recalled?
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model/Catalog Number: MP01855; UDI Number: 04048675420705; Lot numbers: All lot numbers;
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.
States: California Florida Illinois New York Ohio Oklahoma Pennsylvania South Carolina Texas Wisconsin
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0592-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.