ResMed Ltd. recalls Astral 100 and Astral 150 ventilators
If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low battery alarms will sound, but a fault leads to sudden power loss. If power fails, then ventilation stops and a…
Read the official notice →- Date
- 2023-11-01
- Country
- United States
- Brand
- ResMed
- Product
- Astral 100 and Astral 150 ventilators
- Classification
- Class I
- Units
- Worldwide - US Nationwide distribution including in the states of CA, NJ, VA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 ResMed recalls
- 2026-08-05
US
ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for…
Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.
FDA · DeviceResMed Ltd.Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice →- 2023-12-27
US
ResMed Ltd. recalls AirTouch F20 Full Face Mask and User Guide
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing…
FDA · DeviceResMed Ltd.US nationwide distribution including Puerto Rico, Guam, and Virgin Islands.…Official notice →
Other drugs & medical recalls in the United States
- 2023-11-01
US
Acclarent, Inc. recalls TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and…
FDA · DeviceAcclarent, Inc.US: CA, IL, WI, MA, TX, CO, FL, ID, KS, OH, OR, NE, MO, AZ, HI, TN, NY, ME,…Official notice →US
SynCardia Systems LLC recalls SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
FDA · DeviceSynCardia Systems LLCUS: FL, WI, AZ, TX, CA, OH, NC, IN, OK, IL, VA, NY, NE, PA, WA, OUS: Saudi…Official notice →US
B. Braun Medical, Inc. recalls 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to…
FDA · DeviceB. Braun Medical, Inc.Domestic distribution nationwide. Foreign distribution to Canada.Official notice →US
Universal Meditech Inc. recalls DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10
Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips…
FDA · DeviceUniversal Meditech Inc.U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: TaiwanOfficial notice →US
US
Biomic Sciences, LLC dba ION Intelligence of Nature recalls ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA
Microbial contamination of Non-Sterile Products
FDA · DrugBiomic Sciences, LLC dba ION Intelligence of NatureNationwide in the United States and to Canada, New Zealand, Australia,…Official notice →