Ventlab STAT-Check Resuscitation Bag Recall Due to Non-Functional CO2 Indicators
Ventlab LLC is recalling STAT-Check Resuscitation Bags because the carbon dioxide indicators are non-functional and fail to change color during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 where a critical safety indicator (CO2 level) is non-functional, creating a risk of harm due to improper ventilation performance, although no specific injuries are reported in the source text.
Plain-English summary
Ventlab LLC is recalling specific models of STAT-Check Resuscitation Bags, including the SC9001B, SC9001C, SC9001C-C, and SC8001B. The recall involves 2,430 units distributed nationwide to Arizona, Mississippi, New York, Missouri, Florida, Wisconsin, Texas, and California. The affected lot numbers are 303320, 303612, 303400, 303523, 303791, and 303833.
The recall is issued because the carbon dioxide (CO2) indicators on these devices are non-functional. The indicator is yellow when not in use and should turn purple when not in use, but the color will not change during use. Consequently, the device will not indicate CO2 levels or the proper performance of cardiac massage and ventilation.
These devices are intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea. They should only be used by personnel trained in CPR procedures. Users should stop using the affected devices and contact Ventlab LLC for further instructions.
The recalled product
- Product
- STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should…
- Manufacturer
- Ventlab LLC
- Affected units
- 2,430
Distribution
Related recalls
Same manufacturer · Ventlab LLC
See all →- SevereVentlab Manual Resuscitator Bags Recalled Due to Valve Defect
FDA (Devices) · 2014-07-09
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- SevereVentlab Stat-Check Resuscitator Recalled for Possible Volume Leakage
FDA (Devices) · 2012-11-07
- HighManual resuscitators recalled due to carbon dioxide rebreathing defect
FDA (Devices) · 2023-11-29
- 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
- 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