Device recall
VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
- Recall number
- Z-3252-2026
- Event id
- 99787
- Status
- Ongoing
- FDA classification
- Class I
- Recalling firm
- Draeger, Inc.
- Report date
- Oct 7, 2026
- Posted
- Oct 1, 2026
- Initiated
- Sep 3, 2026
- Center classification date
- Sep 30, 2026
- Product code
- BYE
- Device type
- Attachment, Breathing, Positive End Expiratory Pressure
- Reason
- Potential cracks in the hose, which could lead to leakage or the hose falling off.
- Root cause
- Under Investigation by firm
- Quantity
- 1,063,643 units
- Code info
- Part Number MP00310. UDIDI: 04048675422358. All lot numbers.
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K092029
- Location
- Telford, PA, United States