CareFusion EnVe Ventilator Recalled for PEEP Pressure Control Failure
CareFusion 203, Inc. is recalling 266 EnVe Ventilators because they may fail to hold set pressure values or alarm for circuit faults, potentially compromising patient ventilation.
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 high-risk medical device where ventilation delivery may be compromised, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
CareFusion 203, Inc. is recalling 266 units of the CareFusion EnVe Ventilator. The device is designed for patients requiring respiratory support or mechanical ventilation who weigh at least 5 kg (11 lbs) and is used in hospital and transport environments.
The recall was initiated because the ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value intermittently or continuously, or it may alarm for a Patient Circuit Fault. While the unit activates audible and visual alarms to alert healthcare professionals, the source text states that ventilation delivery to the patient may be compromised.
The affected units were distributed nationwide, including in Arizona, California, Colorado, Florida, Illinois, Kentucky, Maine, Michigan, Missouri, Minnesota, Montana, North Dakota, New Jersey, New Mexico, Nevada, New York, Oklahoma, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Wisconsin, and West Virginia. Specific serial numbers are listed in the agency's recall record.
The recalled product
- Product
- CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure
- Manufacturer
- CareFusion 203, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 266
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)
- serial numbers: 26562
- 43634
- 43642
- 43643
- 44536
- 44537
- 44540
- 44541
- 44542
- 44543
- 44544
- 44545
- 44546
- 44552
- 44553
- 44554
- 44555
- 44557
- 44558
- 44559
Distribution
Related recalls
Same manufacturer · CareFusion 203, Inc.
See all →- HighCareFusion EnVe and ReVel Ventilators Recalled for Power Connector Damage Risk
FDA (Devices) · 2014-10-01
Same hazard · pressure control failure
See all →- HighConstellation Vision System surgical units recalled for pressure control defect
FDA (Devices) · 2023-10-18
Other medical device recalls
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract System Convenience Kit Recalled for Performance Failures
FDA (Devices) · 2026-09-02