Recall Z-3252-2026— Draeger, Inc.

Name: FDA recall Z-3252-2026
Creator: U.S. Food and Drug Administration
Published: 2026-09-03

Class I · Ongoing

Class I FDA medical device recall by Draeger, Inc., initiated 2026-09-03. It names one FDA 510(k) clearance: K092029. Product: VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.. Reason: Potential cracks in the hose, which could lead to leakage or the hose falling off..

Recalling firm: Draeger, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2026-09-03
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K092029 — VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310Draeger Medical AG & Co. KG·cleared 2010-08-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.