SonarMed Inc recalls AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
The failure to detect the partial obstruction in a 2.5mm sensor.
Read the official notice →- Date
- 2024-04-24
- Country
- United States
- Brand
- SonarMed
- Product
- AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
- Classification
- Class I
- Units
- Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 SonarMed recalls
- 2024-04-24
USSonarMed Inc recalls AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
FDA · DeviceSonarMed Inc_AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA_Official notice →
Other drugs & medical recalls in the United States
- 2024-04-24
- US
Ethicon, Inc. recalls STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM)…
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
- US
Cook Incorporated recalls Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into…
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
FDA · DeviceCook IncorporatedWorldwide distribution - US Nationwide and the countries of AT, AU, BR, CA,…Official notice → - US
Baxter Healthcare Corporation recalls Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021,…
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate…
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Canada, Ireland,…Official notice → - US
Draeger Medical, Inc. recalls Dr¿ger Perseus A500 Anesthesia Workstation
Unexpected shutdown while operating on battery power.
FDA · DeviceDraeger Medical, Inc.Domestic: Nationwide Distribution; Foreign: Angola, Argentina, Australia,…Official notice → - US
Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
FDA · DevicePhilips Respironics, Inc.Domestic: Nationwide Distribution; Foreign: AE, AR, AT, AU, BD, BE, BG, BO,…Official notice → - US
Outset Medical, Inc. recalls Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that…
FDA · DeviceOutset Medical, Inc.US:FL, CA, NM, SC, AZ, TN, NC, TX, IL, MD, IN, DE, AL, MI, AK, KY, LA, ID, OK,…Official notice →