Ventlab AirFlow Resuscitator Recalled for Inlet Valve Leakage
Ventlab Corporation is recalling 14,602 AirFlow Resuscitators due to possible volume leakage through the inlet valve during bag compressions.
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 classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Ventlab Corporation is recalling 14,602 units of the AirFlow Resuscitator, Adult Resuscitator, AF1000 Series. These single-use disposable resuscitators are intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
The recall is being conducted because of 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 products were distributed nationwide, including in Illinois, Ohio, New York, and Tennessee. Specific product codes and lot numbers are listed in the official recall documentation. Users should stop using the affected devices and contact Ventlab Corporation for instructions on return or replacement.
The recalled product
- Product
- AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, 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…
- 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 (20)
- Product List 071012
- Product Code: AF1040MB
- Lot #102091 and 102191
- AF1040MBP
- Lot #102106 and 102174
- AF1040MBS
- Lot #102189
- AF1040MB-S5
- Lot #102105
- AF1040MB-T
- Lot #101917 and 102151
- AF1100MB
- Lot #102227
- AF1140MB
- Lot #102081 and 102139
- AF1140MB-K
- Lot #102093 and 102165
- AF1140MB-P5
- Lot #102145
- AF1140MBP-T
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 malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
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
- SevereVyaire Medical Recalls AirLife Adult Resuscitation Devices Due to Airflow Obstruction
FDA (Devices) · 2018-08-15
- SevereTeleflex Recalls Lifesaver Manual Resuscitators Due to Potential Intake Port Blockage
FDA (Devices) · 2015-07-01
- SevereDraeger VentStar Resus Neo Neonatal Breathing Circuit Recall
FDA (Devices) · 2026-10-07
- HighAbbott INDEFLATOR Plus 30 Device Recalled for Leaks and Connection Faults
FDA (Devices) · 2022-04-20