Z-3252-2026 Class I Ongoing

Recalled by Draeger, Inc. — Telford, PA

FDA device recall Z-3252-2026 was initiated by Draeger, Inc. on Sep 3, 2026 and is designated Class I. Reason for recall: Potential cracks in the hose, which could lead to leakage or the hose falling off. The recall status is ongoing. Affected quantity: 1,063,643 units.

Recall Details

Product Type
Devices
Report Date
Oct 7, 2026
Initiation Date
Sep 3, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,063,643 units

Product Description

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.

Distribution Pattern

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.

Code Information

Part Number MP00310. UDIDI: 04048675422358. All lot numbers.

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-3252-2026
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.