Class 1 Device Recall VentStar Resus Neo

• Date Initiated by Firm: September 03, 2026
• Date Posted: October 01, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3252-2026
• Recall Event ID: 99787
• 510(K)Number: K092029
• Product Classification: Attachment, breathing, positive end expiratory pressure - Product Code BYE
• Product: VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
• Code Information: Part Number MP00310. UDIDI: 04048675422358. All lot numbers.
• FEI Number: 2517967
• Recalling Firm/ Manufacturer: Draeger, Inc.; 3135 Quarry Rd; Telford PA 18969-1042
• For Additional Information Contact: Karina Howard; 01-445-2240698
• Manufacturer Reason for Recall: Potential cracks in the hose, which could lead to leakage or the hose falling off.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = BYE