CLASS I ONGOING Device recall · Reported 7 Oct 2026 · FDA Enforcement Report

VentStar Resus Neo recalled by Draeger

Draeger is recalling VentStar Resus Neo, distributed nationwide in the US. The recall was initiated on 3 Sep 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesPart Number MP00310. UDIDI: 04048675422358. All lot numbers.

Quantity recalled1,063,643 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-3252-2026
FDA event ID: 99787
Recalling firm: Draeger, Telford, PA
Classification: Class I
Status: Ongoing
Recall initiated: 3 Sep 2026
FDA classified: 30 Sep 2026
Reported: 7 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

3 Sep 2026	Recall initiated by company
30 Sep 2026	Classified by FDA	+27 days
7 Oct 2026	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

Potential cracks in the hose, which could lead to leakage or the hose falling off.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.

Where it was distributed

US Nationwide distribution including in the states of IN, AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VT, WA, WI, WV, WY, MS, SC, UT, VA, AR, and territories AS and PR. The countries of Canada, Germany, United Kingdom, Spain, Italy, Ireland, Poland, Australia, Switzerland, Netherlands, Portugal, France, Austria, Hong Kong, Malaysia, Costa Rica, Andorra, Belgium, Sweden, Cyprus, Greece, Latvia, Romania, Albania, Moldavia, Kazakhstan, Croatia, Libya, Mauritius, Honduras, Suriname, Uruguay, Syria, Israel, Kuwait, Bahrain, Qatar, Utd.Arab.Emir., Oman, Denmark, Norway, New Zealand, Brunei Darussalam, Singapore, China, India, Japan.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Delaware Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Michigan Minnesota Missouri

Questions about this recall

Why was it recalled?

Potential cracks in the hose, which could lead to leakage or the hose falling off.

Which lots are affected?

Part Number MP00310. UDIDI: 04048675422358. 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 13 Oct 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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