US FDA MedWatch

Disposable Surgical Stapler Cartridge Correction: Ethicon Endo-Surgery, LLC Issues Correction for Endopath Echelon to Address an Inadvertent Lockout During Surgical Procedures fda.gov/medical-device…

Arterial Cannula Recall: Edwards Lifesciences Removes Arterial Cannula due to Risk of Wire Exposure fda.gov/medical-device…

Early Alert: Infusion Pump Issue from Baxter fda.gov/medical-device…

Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Craniotomy Kits Containing Codman Disposable Perforators Due to Risk for Device Disassembly fda.gov/medical-device…

Continuous Ventilator (Respirator) Correction: Maquet Critical Care AB Updates Use Instructions for Servo Ventilator Systems Due to Risk of Inaccurate Compliance Measurement Leading to Improper Tidal Volume Delivery in Neonatal Patients fda.gov/medical-device…

Applicator Recall: Integra LifeSciences Removes MicroMyst Applicators Due to Potential Sterility Concerns fda.gov/medical-device…

Manual Resuscitator Recall: SunMed Holdings, LLC Removes Adult Manual Resuscitator Devices Due to Incorrect Assembly of B/V Filter fda.gov/medical-device…

Sucralfate Tablets USP, 1 Gram by Nostrum Laboratories: Recall - Due to Company Closure and Discontinuation of Quality Activities fda.gov/safety/recalls…

Cranial Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators Due to Risk of Device Disassembly fda.gov/medical-device…

Continuous Glucose Monitor Receiver Recall: Dexcom, Inc. Removes Certain Dexcom G6, G7, ONE, and ONE+ Receivers Due to Speaker Malfunction That May Cause Missed Alerts for Dangerous Blood Sugar Levels fda.gov/medical-device…

Portable Oxygen Concentrator Car DC Power Adapter Recall: Drive DeVilbiss Healthcare Removes iGo DV6X-619 DC Car Adapter Due to Power Adapter Possibly Becoming Hot to the Touch and/or Melting While Being Used fda.gov/medical-device…

One Additional Lot of Cefazolin for Injection by Sandoz: Recall Expansion - Due to Vials Being Potentially Mislabeled as Penicillin G Potassium for Injection fda.gov/safety/recalls…

Early Alert: Microbore Extension Set Issue from B. Braun Medical Inc. fda.gov/medical-device…

Early Alert: Infusion Set Performance Issue from BD fda.gov/medical-device…

Closed Suction Catheter Recall: Avanos Medical, Inc. Removes Ballard Closed Suction Systems Due to Risk of Non-Sterility fda.gov/medical-device…

Infant Breathing System Recall: AirLife/Vyaire Removes Infant Heated Wire Circuits Due to Risk for Inadvertent Adapter Disconnection During Ventilation fda.gov/medical-device…

FDA Advises Consumers Not to Inhale Nitrous Oxide Products. Due to Potential for Severe Adverse Events if Used for Recreational/Non-Food Purposes fda.gov/food/alerts-ad…

UPDATE: Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed: FDA Safety Communication fda.gov/medical-device…

Extended-Release Stimulants for ADHD: FDA Drug Safety Communication - FDA Requires Expanded Labeling about Weight Loss Risk in Patients Younger than 6 Years. Action Will Harmonize Labeling Across Extended-Release Stimulant Drug Class fda.gov/safety/medical…

Early Alert: Blood Pump Controller Issue from Abiomed fda.gov/medical-device…