Vyaire Medical recalls bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is…
Potential cessation in ventilation can occur under specific conditions.
Read the official notice →- Date
- 2022-02-23
- Country
- United States
- Brand
- Vyaire Medical
- Product
- bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is…
- Classification
- Class I
- Units
- Worldwide distribution - US Nationwide distribution in the states of AL, CA,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Vyaire Medical recalls
- 2025-05-21
USVyaire Medical recalls Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product…
Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
FDA · DeviceVyaire MedicalWorldwide distribution - US Nationwide and the countries of Germany, Poland,…Official notice →- 2024-05-15
- US
Vyaire Medical, Inc. recalls Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX.…
Potential of the nozzle separating during patient use.
- 2024-03-06
- US
Vyaire Medical recalls AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may…
FDA · DeviceVyaire MedicalWorldwide distribution. US nationwide, Brazil, Canada, Switzerland, France,…Official notice → - 2023-12-13
- US
Vyaire Medical recalls vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.
- 2023-06-21
- US
Vyaire Medical recalls bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application…
Other drugs & medical recalls in the United States
- 2022-02-23
- US
Hill-Rom, Inc. recalls Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015
Missing bushing on Liko M220 and M230 causing wear and potential for patient falling
FDA · DeviceHill-Rom, Inc.Worldwide distribution - US Nationwide and the countries of Austria, Austria,…Official notice → - US
Olympus Corporation of the Americas recalls OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible…
The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent…
- US
TELEFLEX MEDICAL INC recalls Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The…
The firm received reports indicating PTD tip separation during use.
FDA · DeviceTELEFLEX MEDICAL INCWorldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ,…Official notice → - US
BASE 10 GENETICS INC recalls RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen…
The product does not have 510(k) clearance.
FDA · DeviceBASE 10 GENETICS INCUS Nationwide distribution in the states of AL, CO, FL, GA, ID, IN, KY, MD,…Official notice → - US
Teligent Pharma, Inc. recalls Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by:…
Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
- US
Revive Rx LLC dba Revive Rx Pharmacy recalls HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded…
Non-sterility; bacterial contamination identified as Paenibacillus lautus.