Ventlab Premium Small Child Resuscitator Recalled for Valve Leakage
Ventlab Corporation is recalling 14,602 Premium Small Child Resuscitators due to possible volume leakage through the inlet valve during compressions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that poses a risk of harm (inadequate resuscitation) but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Ventlab Corporation is recalling 14,602 units of the Ventlab Premium Small Child Resuscitator. The recall is due to a defect where volume may leak through the inlet valve during compressions of the resuscitator bag.
The affected units are identified by Product Code VN4100OB and Lot #102015. These devices were distributed nationwide, including in Illinois, Ohio, New York, and Tennessee.
Consumers and healthcare facilities should stop using the affected resuscitators and contact Ventlab Corporation for further instructions on the recall.
The recalled product
- Product
- Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.
- Manufacturer
- Ventlab Corporation
- Category
- Medical Device — Resuscitator
- Hazard
- Affected units
- 14,602
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Code: VN4100OB
- Lot #102015.
Distribution
Part of a larger recall action
This product is one of 12 recalled by Ventlab Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
Same manufacturer · Ventlab Corporation
See all →- ModerateVentlab V*Care Infant Resuscitator Recalled for Potential Volume Leakage
FDA (Devices) · 2012-11-07
- SevereVentlab Infant Resuscitator Recalled for Possible Volume Leakage
FDA (Devices) · 2012-11-07
- HighVentlab Premium Small Adult Resuscitator Recalled for Valve Leakage
FDA (Devices) · 2012-11-07
- SevereVentlab AirFlow Infant Resuscitator Recalled for Inlet Valve Leakage
FDA (Devices) · 2012-11-07
- HighVentlab AirFlow Resuscitator Recalled for Possible Volume Leakage
FDA (Devices) · 2012-11-07
Same hazard · device defect
See all →- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22