Ventlab Premium Small Adult Resuscitator Recalled for Valve Leakage
Ventlab Corporation is recalling 14,602 Premium Small Adult Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.
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 intended for life-support during cardiopulmonary arrest. While no injuries or illnesses are reported in the source text, the potential failure of a critical life-support device represents a risk of harm where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Ventlab Corporation is recalling 14,602 units of the Ventlab Premium Small Adult Resuscitator, product code VN500MX, lot #102194. These disposable resuscitators are intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
The recall was initiated because of a possible volume leakage through the inlet valve during compressions of the resuscitator bag. This defect could compromise the device's ability to provide adequate respiratory support.
The affected units were distributed nationwide, including in Illinois, Ohio, New York, and Tennessee. Users should stop using the affected devices and contact Ventlab Corporation for further instructions.
The recalled product
- Product
- Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly a
- Manufacturer
- Ventlab Corporation
- 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: VN500MX
- Lot #102194.
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
- 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
- HighVentlab Safe Spot Infant Resuscitator Recalled for Valve Leakage
FDA (Devices) · 2012-11-07
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- HighNeuroguard IEP Carotid Stent and Balloon System Recalled for Filter Failure Risk
FDA (Devices) · 2026-08-12
- HighIntegrated Medcraft Recalls First Aid Kits with Defective Airway Tips
FDA (Devices) · 2026-08-12