Z-3252-2026

VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use...

Name: Z-3252-2026 VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use...
Creator: Draeger, Inc.
Published: 2026-09-03
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2026-09-03 / Open, Classified

FDA source

Recall record

Recall number: Z-3252-2026
Status: Open, Classified
Initiated: 2026-09-03
Posted: 2026-10-01
Recalling firm: Draeger, Inc.
Product: VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
Product code: BYE Attachment, Breathing, Positive End Expiratory Pressure
Reason for recall: Potential cracks in the hose, which could lead to leakage or the hose falling off.
FDA 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 potential users within the facility, and if affected products have been transferred or distributed, to notify those customers. Additionally, customers were requested to complete and return the provided Medical Device Recall Return Response Acknowledgement and Receipt Form. Draeger will replace the affected circuits free of charge after a correction is implemented based on the quantity indicated on the Medical Device Recall Return Response Acknowledgement and Receipt Form.
Quantity in commerce: 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.
Product codes and lots: Part Number MP00310. UDIDI: 04048675422358. All lot numbers.

Product code BYE

K092029Class IIVentstar Resuscitaire, Model Mp00311, Ventstar Resuscitaire Ceu, Model Mp00310Draeger Medical AG & Co. KG / cleared 2010-08-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-09. View this recall on fda.gov (opens on fda.gov)