Device recall: bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e

FDA enforcement event 89366 · Class I · initiated 20 Dec 2021 · status Terminated · terminated 28 Aug 2024

DeviceVoluntary: Firm initiated1 product recordMettawa, IL

FDA enforcement event 89366 is a device recall by Vyaire Medical of Mettawa, IL, initiated 20 Dec 2021 and classified Class I, with 1 product record.

FDA defines Class I as 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. 8% of the 900 device enforcement events initiated in 2021 carry the same class.

Status: Terminated, terminated 28 Aug 2024. Initiation: voluntary: firm initiated. Vyaire Medical has 12 enforcement events on this register, with a median of 2 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Vyaire Medical, Mettawa, IL.

Reason for recall

"Potential cessation in ventilation can occur under specific conditions."

Distribution

"Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, CT, DC, FL, GA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OK, PA, SD, TX, VA, WA, WI and WV, including…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0622-2022	bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally, infant and neonatal patients.	4189 units	Class I	Terminated	23 Feb 2022

Context

8%of 2021 device events are Class I900 events that year

1product record in this eventfirm median: 2

12events on this register for the firm

Other enforcement events for Vyaire Medical

Initiated	Product (first record)	Type	Class	Records
10 Apr 2025	Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A P	Device	Class I	2
10 Jan 2024	AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,	Device	Class I	9
27 Oct 2023	vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ven	Device	Class II	2
5 May 2023	bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator	Device	Class II	2
25 Nov 2019	bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation	Device	Class II	1
13 Mar 2019	enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.	Device	Class I	2
20 Jun 2018	The Tri-Flo Subglottic Suction System	Device	Class I	1
8 May 2018	AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8	Device	Class I	2
18 Jul 2017	AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2	Device	Class II	1
27 Apr 2017	AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usage: The AirLife Resuscitation devices are manua	Device	Class I	35

All 12 events for Vyaire Medical

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Potential cessation in ventilation can occur under specific conditions."

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, CT, DC, FL, GA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OK, PA, SD, TX, VA, WA, WI and WV, including…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 28 Aug 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.