VentStar Resus Neo. Neonatal. 25 Units per Box. Part… recallZ-3252-2026 · Draeger, Inc. · initiated Sep 3, 2026

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Draeger, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential cracks in the hose, which could lead to leakage or the hose falling off.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number: Z-3252-2026
Status: Open, Classified
Initiated by the company: Sep 3, 2026
Posted by the FDA: Oct 1, 2026
Recalling firm: Draeger, Inc.
Quantity: 1,063,643 units
Product code: BYE
FDA submissions: K092029
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 description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

VentStar Resuscitaire CEU MP00310
Drägerwerk AG & Co. KGaA · Attachment, Breathing, Positive End Expiratory Pressure
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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