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Open, Classified

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

FDA Recall Z-3252-2026 · Posted 2026-10-01

Recalling FirmDraeger, Inc.
Recall StatusOpen, Classified
Product CodeBYE
Date Initiated2026-09-03
Product Quantity1,063,643 units

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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