Vyaire Medical Recalls bellavista 1000 Ventilators Due to Alarm Failures
Vyaire Medical is recalling 116 bellavista 1000 ventilators because they may fail to sound high-priority alarms or respond to touch screen input.
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 is classified as FDA Class II, and the hazard involves a medical device failure (alarm and touch screen) that poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Vyaire Medical is recalling 116 units of the bellavista 1000 ventilator, catalog number 301.100.030. The recall was initiated because the devices may experience intermittent failures, specifically a lack of acoustic high-priority alarms, a 'no alarm' condition, or a non-responsive touch screen.
The affected ventilators were distributed nationwide in the states of Alabama, California, Colorado, Florida, Georgia, Illinois, Maryland, Michigan, Pennsylvania, Texas, Washington, and Puerto Rico. The recall covers specific serial numbers listed in the agency's official documentation.
Consumers and healthcare facilities should stop using the affected ventilators and contact Vyaire Medical for instructions on how to proceed. The company is responsible for managing the recall and providing necessary support to affected users.
The recalled product
- Product
- bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxygen. Air enters through a fresh gas intake port and is…
- Manufacturer
- Vyaire Medical
- Category
- Medical Device — Ventilator
- Affected units
- 116
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: MB170104
- MB170118
- MB170151
- MB170202
- MB230000
- MB230020
- MB230024
- MB230027
- MB230031
- MB230033
- MB230035
- MB230036
- MB230037
- MB230038
- MB230039
- MB230040
- MB230041
- MB230046
- MB230048
- MB230049
Distribution
Related recalls
Same manufacturer · Vyaire Medical
See all →- SevereAirLife Infant Heated Wire Circuit Adapter Disconnection Risk Recall
FDA (Devices) · 2025-05-21
- SevereAirLife Infant Heated Wire Circuit Adapter Disconnection Risk
FDA (Devices) · 2025-05-21
- SevereAirLife Adult Manual Resuscitator units recalled for component failure
FDA (Devices) · 2024-03-06
- SevereAirLife Adult Manual Resuscitator recalled for ventilation failure risk
FDA (Devices) · 2024-03-06
- SevereAirLife Manual Resuscitator recalled for broken components causing ventilation failure
FDA (Devices) · 2024-03-06
Same hazard · alarm failure
See all →- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- HighTreatlife smoke and carbon monoxide detectors can fail to alarm
CPSC · 2026-06-25
- SevereAutomated Impella Controllers recalled over alarm, power and purge cassette faults
FDA (Devices) · 2026-06-03
- HighVital Sync remote monitoring may not receive bedside monitor alarms
FDA (Devices) · 2026-03-18
- HighSmoke alarms recalled because they may not sound in time
CPSC · 2026-02-12
Similar recalls
- SevereVyaire Medical Ventilators Recalled Due to Potential Ventilation Failure
FDA (Devices) · 2022-02-23
- Highbellavista 1000 Ventilator Recalled for Software Hang and Use Error Risk
FDA (Devices) · 2023-06-21
- Highbellavista 1000e Ventilator Software May Hang, Affecting Device Interface
FDA (Devices) · 2023-06-21
- HighBreas Vivo 50 Home Care Ventilator Recalled for Keypad Malfunction
FDA (Devices) · 2015-07-22
- SevereVyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
FDA (Devices) · 2018-05-16
- SevereResMed Stellar Ventilators Recalled for Potential Alarm Failure
FDA (Devices) · 2020-02-12