Route 92 Medical Inc. Recalls Catheter due to Distal Tip Separation at the Proximal Marker Band fda.gov/medical-device…

Safely Charge Hearing Aids, Glucose Monitors, Insulin Pumps, and Other Medical Devices to Avoid Overheating fda.gov/medical-device…

Safety and Quality Concerns with Getinge/Maquet Cardiovascular Devices - Letter to Health Care Providers fda.gov/medical-device…

Tandem Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ Technology Prompted by a Software Problem Leading to Pump Battery Depletion fda.gov/medical-device…

BioMérieux Inc. Recalls VITEK 2 AST Kit due to Incorrect Ceftriaxone Concentrations fda.gov/medical-device…

SonarMed Inc. Recalls Acoustic Sensors Due to a Restricted Inner Diameter of Airway Causing Suction Catheter Passage Difficulty fda.gov/medical-device…

SonarMed Inc. Recalls Airway Monitors Due to a Software Anomaly Resulting in Failure to Detect a Partial Obstruction in 2.5mm Sensors and Up To 3mm Distal to the Sensor Tip fda.gov/medical-device…

Elekta Instrument AB Recalls Disposable Biopsy Needle Kit for Leksell Stereotactic System for Possibly Containing Microscopic Stainless-Steel Debris on the Inside of the Biopsy Needle fda.gov/medical-device…

InfuTronix, LLC Recalls Nimbus and Nimbus II Infusion Pump Systems for Multiple Device Failures That May Cause Severe Injury and Death fda.gov/medical-device…

Draeger, Inc. Recalls Perseus A500 Anesthesia System for Risk of Sudden Unexpected Shutdown When Used on Battery Power fda.gov/medical-device…

Outset Medical, Inc. Recalls Tablo Hemodialysis System for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA fda.gov/medical-device…

Fresenius Medical Care Recalls Stay-Safe Catheter Extension Sets and Stay-Safe /Luer Lock Adapter for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA fda.gov/medical-device…

DeRoyal Industries, Inc. Recalls Tracecarts Containing 16FR Urine Meter Foley Under Recall by Nurse Assist fda.gov/medical-device…

Sapropterin Dihydrochloride Powder for Oral Solution 100 mg by Dr. Reddy's: Recall - Due to Sub-Potency fda.gov/safety/recalls…

Schwinnng Capsules by STOP CLOPEZ CORP: Recall - Due to the Presence of Undeclared Nortadalafil fda.gov/safety/recalls…

FDA Encourages the Public to Follow Established Choking Rescue Protocols - FDA Safety Communication fda.gov/medical-device…

Fresenius Kabi USA, LLC Recalls Ivenix Infusion Pump LVP Software for Anomalies That Have the Potential to Cause Serious Patient Harm or Death fda.gov/medical-device…

Boston Scientific Recalls Obsidio Embolic for Bowel Ischemia Risk fda.gov/medical-device…

Abbott/Thoratec Corp. Recalls Heartmate II and Heartmate 3 Left Ventricular Assist System (LVAS) Due to Long-term Buildup of biological material Causing an Obstruction fda.gov/medical-device…

Tejocote Products by Global Mix: Recall - Because of Possible Health Risk fda.gov/safety/recalls…