Recall Z-3252-2026 ยท BYE Attachment, Breathing, Positive End Expiratory Pressure
Draeger, Inc.
VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
| Date | Oct 1, 2026 (initiated Sep 3, 2026) |
| Status | Open, Classified |
| Reason | Potential cracks in the hose, which could lead to leakage or the hose falling off. |
| Root cause | Under Investigation by firm |
| Action | Draeger notified consignees on about 09/03/2026 via emailed Urgent Medical Device Recall letter. Consignees were informed of the issue of a cracked hose and that currently there are no alternative products from other manufacturers that have been tested and approved by Draeger for use with these devices, nor are there substitute products available within the Draeger portfolio in the U.S. Consignees were instructed to carefully inspect the hoses for damages prior to use according to the product s Instructions for Use (IFU), discard products that show cracks or have a detached hose, inform all po |
| 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 Ki |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092029 | VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 Draeger Medical AG & Co. KG, Aug 6, 2010 |