CLASS I ONGOING Device recall · Reported 1 Mar 2023 · FDA Enforcement Report

NovaStar TS, Anti-Asphyxia Valve, Reusable recalled by Draeger Medical

Draeger Medical is recalling NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577, distributed nationwide in the US. The recall was initiated on 23 Jan 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll Lot numbers. UDI-DI: 04048675041146 (MP10576); 04048675041153 (MP01577); 04048675041160 (MP01578)

Quantity recalled16 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-1137-2023
FDA event ID: 91538
Recalling firm: Draeger Medical, Telford, PA
Classification: Class I
Status: Ongoing
Recall initiated: 23 Jan 2023
FDA classified: 23 Feb 2023
Reported: 1 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

23 Jan 2023	Recall initiated by company
23 Feb 2023	Classified by FDA	+31 days
1 Mar 2023	Published in enforcement report	+6 days

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

Reason for recall

The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.

Product as listed by the FDA

NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.

Which lots are affected?

All Lot numbers. UDI-DI: 04048675041146 (MP10576); 04048675041153 (MP01577); 04048675041160 (MP01578)

Where was it sold?

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 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

1 other product · FDA event 91538

This product is part of a recall event; the main page for the event is NovaStar TS, Standard elbow, Reusable recalled by Draeger Medical.

Reported	Class	Recall	Company	Reason	Where
1 Mar 2023	CLASS I	NovaStar TS, Standard elbow, Reusable recalled by Draeger Medical	Draeger Medical	Other	Nationwide

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