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Stop using now Medical device recall · FDA · Published September 3, 2026

Draeger VentStar Resus Neo Neonatal Breathing Circuit: Potential Hose Cracks

Draeger recalls 1,063,643 VentStar Resus Neo neonatal breathing circuits due to potential hose cracks causing leakage or disconnection. Stop using immediately.

🇺🇸 FDA recall #Z-3252-2026Medical deviceDraeger ›
✎ GovInfoNow plain-language explainer

Draeger is recalling 1,063,643 VentStar Resus Neo neonatal breathing circuits because they may have cracks in the hose that could leak or fall off during use. This poses a serious risk to newborns during resuscitation. Read more at govinfonow.com/recall/1449218-draeger-inc-recalls-ventstar-resus-neo-neonatal-25-units-per.

Source Summary by GovInfoNow · govinfonow.com/recall/1449218-draeger-inc-recalls-ventstar-resus-neo-neonatal-25-units-per · Updated October 14, 2026 · FDA enforcement record: FDA #Z-3252-2026

Cite this page

“Draeger VentStar Resus Neo Neonatal Breathing Circuit: Potential Hose Cracks.” GovInfoNow, updated October 14, 2026. https://govinfonow.com/recall/1449218-draeger-inc-recalls-ventstar-resus-neo-neonatal-25-units-per. Based on FDA recall #Z-3252-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3252-2026%22&limit=1).

Draeger, Inc. voluntarily recalled VentStar Resus Neo Neonatal Disposable Breathing Circuits (Part Number MP00310) due to potential hose cracks that could cause leakage or disconnection, the FDA said on Sept. 3, 2026.

How to tell if you have it

  • Brand: Draeger
  • Product: VentStar Resus Neo Neonatal Disposable Breathing Circuit
  • Part Number: MP00310
  • UDIDI: 04048675422358
  • Lot codes: All lot numbers
  • Quantity: 1,063,643 units

The hazard

The recall addresses potential cracks in the breathing circuit hose, which could lead to leakage or the hose falling off during use. The FDA classified this as a Class I recall.

Context

GovInfoNow's records show Draeger, Inc. has initiated six other recalls since March 12, 2025. Other recent recalls of similar products include Medline Neonatal Breathing Circuits Risk of Sporadic Failure in Infants (July 13, 2026), Medline Hudson RCI Breathing Circuits Recall: Risk of Infant Respiratory Failure (July 13, 2026), and Medline Breathing Circuits Recall: Risk of Infant Breathing Failure (July 13, 2026).

How to tell if you have this one

Check for the part number MP00310 on the circuit packaging. The product was sold nationwide in the US and internationally from 2026-09-03 onward. All lot numbers are affected.

  • Brand
    Draeger
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Stop using it now

    Immediately stop using the VentStar Resus Neo neonatal breathing circuit if it has the part number MP00310.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 43 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 34 days after the firm started it.

1. Firm started the recall: Sep 3, 202612. FDA classified it Class I: Sep 30, 202623. Published in FDA’s Enforcement Report: Oct 7, 202634. Added to GovInfoNow: Oct 13, 202642026
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Where was the product sold?

The product was sold nationwide in the US and internationally in countries including Canada, Germany, the United Kingdom, and many others.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-3252-2026 (September 3, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3252-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on October 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA