CLASS I Device recall · Reported 24 May 2023 · FDA Enforcement Report

VentStar Basic (P)180, MP00351 recalled by Draeger Medical

Draeger Medical is recalling VentStar Basic (P)180, MP00351, distributed nationwide in the US. The recall was initiated on 17 Apr 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI-DI: 04048675422068; All lots.

Quantity recalled325 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-1440-2023
FDA event ID: 92049
Recalling firm: Draeger Medical, Telford, PA
Classification: Class I
Status: Terminated
Recall initiated: 17 Apr 2023
FDA classified: 17 May 2023
Reported: 24 May 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

17 Apr 2023	Recall initiated by company
17 May 2023	Classified by FDA	+30 days
24 May 2023	Published in enforcement report	+7 days

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

Reason for recall

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Product as listed by the FDA

VentStar Basic (P)180, MP00351

Where it was distributed

Domestic: US Nationwide Distribution.

Nationwide

Questions about this recall

Is VentStar Basic (P)180, MP00351 recalled?

Yes. Draeger Medical recalled VentStar Basic (P)180, MP00351 on 17 Apr 2023. The recall is Class I and its status is Terminated. Recall number Z-1440-2023.

Why was it recalled?

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Which lots are affected?

UDI-DI: 04048675422068; All lots.

Where was it sold?

Domestic: US Nationwide Distribution.

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

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