CLASS I ONGOING Device recall · Reported 17 Dec 2025 · FDA Enforcement Report

ErgoStar CM recalled by Draeger

Draeger is recalling ErgoStar CM 55, distributed in 10 states. The recall was initiated on 10 Nov 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel/Catalog Number: MP01855; UDI Number: 04048675420705; Lot numbers: All lot numbers;

Quantity recalled118850 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0592-2026
FDA event ID: 97923
Recalling firm: Draeger, Telford, PA
Classification: Class I
Status: Ongoing
Recall initiated: 10 Nov 2025
FDA classified: 8 Dec 2025
Reported: 17 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: CPAP & Ventilators

Timeline

10 Nov 2025	Recall initiated by company
8 Dec 2025	Classified by FDA	+28 days
17 Dec 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

California Florida Illinois New York Ohio Oklahoma Pennsylvania South Carolina Texas Wisconsin

Questions about this recall

Why was it recalled?

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

Which lots are affected?

Model/Catalog Number: MP01855; UDI Number: 04048675420705; Lot numbers: All lot numbers;

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 97923

This product is part of a recall event; the main page for the event is ErgoStar CM recalled by Draeger.

Reported	Class	Recall	Company	Reason	Where
17 Dec 2025	CLASS I	ErgoStar CM recalled by Draeger	Draeger	Device Malfunction	10 states
17 Dec 2025	CLASS I	ErgoStar CM recalled by Draeger	Draeger	Device Malfunction	10 states
17 Dec 2025	CLASS I	ErgoStar CM recalled by Draeger	Draeger	Device Malfunction	10 states

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