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  1. Safety Communications

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.

2022 Safety Communications

Date Safety Communication Product Area Español
11/17/2022 UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication    
11/03/2022 Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition: FDA Safety Communication Neurological & Physical Medicine Devices Español
10/31/2022 Reuse Tracheostomy Tubes or Switch to Appropriate Alternatives During Shortage: FDA Safety Communication Respiratory Español
10/25/2022 Do Not Use Certain Mighty Bliss Electric Heating Pads Due to Risk of Injury: FDA Safety Communication Physical Medicine Español
09/15/2022 UPDATE: Pulse Oximeter Accuracy and Limitations: FDA Safety Communication   Español
09/08/2022 Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication Plastic and Reconstructive Surgery Español
09/06/2022 Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication Respiratory Español
08/29/2022 Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication Respiratory  Español
08/11/2022 At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication In Vitro Diagnostics  Español
07/21/2022 UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication Plastic and Reconstructive Surgery Español
07/20/2022 Do Not Use Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation: FDA Safety Communication Radiological Health Español
07/15/2022 Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety Communication In Vitro Diagnostics Español
06/30/2022 UPDATE: Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication Radiological Health Español
06/28/2022 Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication Physical Medicine Español
06/02/2022 UPDATE: FDA Updates Recommendations for the Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication Plastic and Reconstructive Surgery  
05/10/2022 Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA Safety Communication In Vitro Diagnostics  
04/19/2022 Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety Communication In Vitro Diagnostics Español
04/05/2022 Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication Gastrointestinal  
03/18/2022 Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm: FDA Safety Communication In Vitro Diagnostics  
03/14/2022 FDA Warns Against Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication Plastic and Reconstructive Surgery  
03/01/2022 Do Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication In Vitro Diagnostics  
03/01/2022 Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests: FDA Safety Communication In Vitro Diagnostics  
03/01/2022 Do Not Use Certain Celltrion DiaTrust COVID-19 Tests: FDA Safety Communication In Vitro Diagnostics  
02/08/2022 Potential Risk of Strangulation in Children Who Use Enteral Feeding Delivery Sets - FDA Safety Communication Drug Delivery  
02/04/2022 Do Not Use E25Bio COVID-19 Tests: FDA Safety Communication In Vitro Diagnostics  
01/28/2022 Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication In Vitro Diagnostics  
01/13/2022 Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems - FDA Safety Communication Cardiovascular  
01/11/2022 Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication In Vitro Diagnostics  

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