VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resu
Summary
The FDA issued a Class I for VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposab by Draeger, Inc.. Reason: Potential cracks in the hose, which could lead to leakage or the hose falling off..
Details
Source
Device Recall
External ID
Z-3252-2026
Action Date
2026-10-07
Status
Ongoing
Category
device
Product Description
VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
Lot/Code Info: Part Number MP00310. UDIDI: 04048675422358. All lot numbers.
Quantity Affected: 1,063,643 units
Reason for Recall
Potential cracks in the hose, which could lead to leakage or the hose falling off.
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 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-03
Company
Telford, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 238 device recalls issued in the same week, part of 518 device-related FDA actions this month.
Draeger, Inc. has 22 FDA actions in our database, including 22 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Draeger, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Draeger, Inc. have FDA actions?
Draeger, Inc. has 22 FDA actions in our database, including 22 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3252-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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