VentStar Resus Neo
VentStar Resus Neo disposable breathing circuit may have cracks in the hose, which could lead to leakage or the hose falling off.
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
What happened
Draeger, Inc. recalled 1,063,643 units of the VentStar Resus Neo neonatal disposable breathing circuit due to potential cracks in the hose, which could lead to leakage or the hose falling off. The company began the recall on September 3, 2026, and the FDA classified it on September 30, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your box affected?
Affected if its UDI-DI matches.
VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
- UDI-DI
- 04048675422358
- Lot
- All lot numbers.
Details
- Company began the recall
- Sold in
US Nationwide distribution including in the states of Indiana, Alaska, Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, Wisconsin, West Virginia, Wyoming, Mississippi, South Carolina, Utah, Virginia, Arkansas, 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.
- Event ID
- 99787
- Recall No.
- Z-3252-2026
- Company
- Draeger, Inc.Telford, Pennsylvania
- Hazard
- Device defect
- Quantity recalled
- 1,063,643 units
Company began the recall
Classified by FDA
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
