Ventlab Pro-5000 Adult Resuscitator Recalled for Volume Leakage
Ventlab Corporation is recalling 14,602 Pro-5000 Series Adult Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Possible volume leakage through the inlet valve during compressions of the resuscitator bag."
Plain-English summary
Ventlab Corporation is recalling 14,602 units of the Pro-5000 Series Adult Resuscitator, Single Patient Use. These disposable resuscitators are intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. The recall covers units with Product Code PRO-5009P and Lot #102217.
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 to patients.
The affected units were distributed nationwide, including in Illinois, Ohio, New York, and Tennessee. Healthcare facilities and users should stop using the affected resuscitators and contact Ventlab Corporation for further instructions or replacement.
The recalled product
- Product
- Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
- 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 (3)
- Product List 071012
- Product Code: PRO-5009P
- Lot #102217.
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 →- SevereVentlab Premium Small Adult Resuscitator Recalled for Valve Leakage
FDA (Devices) · 2012-11-07
- SevereVentlab Infant Resuscitator Recalled for Possible Volume Leakage
FDA (Devices) · 2012-11-07
- SevereVentlab V*Care Infant Resuscitator Recalled for Potential Volume Leakage
FDA (Devices) · 2012-11-07
- SevereVentlab AirFlow Infant Resuscitator Recalled for Inlet Valve Leakage
FDA (Devices) · 2012-11-07
- SevereVentlab AirFlow Resuscitator Recalled for Possible Volume Leakage
FDA (Devices) · 2012-11-07
Same hazard · device defect
See all →- SevereBard Access Systems Recalls Power-Trialysis Dialysis Catheters
FDA (Devices) · 2026-09-23
- SevereBoston 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
Similar recalls
- SevereVentlab Manual Resuscitator Bags Recalled Due to Valve Defect
FDA (Devices) · 2014-07-09
- HighVentlab AirFlow Manual Resuscitators Recalled for CO2 Rebreathing Risk
FDA (Devices) · 2023-11-29
- HighSun Med Recalls Medline Adult Manual Resuscitators Due to Port Detachment Risk
FDA (Devices) · 2018-06-20
- SevereSun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk
FDA (Devices) · 2018-06-20
- SevereVyaire Medical Recalls AirLife Adult Resuscitation Devices Due to Airflow Obstruction
FDA (Devices) · 2018-08-15
- HighSun Med Recalls Adult Manual Resuscitators Due to Port Retaining Ring Defect
FDA (Devices) · 2018-06-20