FDAFDA recall Z-3252-2026 · Oct 7, 2026
Draeger, Inc.: VentStar Resus Neo recall
Recall found
Product
VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
Reason for recall
Potential cracks in the hose, which could lead to leakage or the hose falling off.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- Part Number MP00310. UDIDI: 04048675422358. All lot numbers.
- Quantity
- 1,063,643 units
- 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.
- Recalling firm
- Draeger, Inc., Telford, PA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-03
Source: openFDA enforcement record Z-3252-2026 · search recall number Z-3252-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.