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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.

2021 Safety Communications

Device Name Date
Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication 11/12/2021
Potential for Medication Overdose with ENFit Low Dose Tip Syringe: FDA Safety Communication 10/12/2021
Do Not Use Needle-Free Devices for Injection of Dermal Fillers – FDA Safety Communication 10/08/2021
Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue: FDA Safety Communication 10/05/2021
Risk of Exposure to Unsafe Levels of Radiation with Safe-T-Lite UV WAND: FDA Safety Communication (updated 07/20/2022) 09/29/2021
Mammography Problems at Madison Avenue Radiology Center 190th Broadway in New York, New York: FDA Safety Communication 08/26/2021
UPDATE: Caution with Robotically-Assisted Surgical Devices in Mastectomy: FDA Safety Communication 08/20/2021
Potential Concerns with NuVasive MAGEC System Implants - FDA Safety Communication 07/15/2021
Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication (updated 11/12/2021) 06/30/2021
Flexible Bronchoscopes and Updated Recommendations for Reprocessing: FDA Safety Communication 06/25/2021
Stop Using Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety Communication 06/10/2021
Stop Using Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody Tests: FDA Safety Communication 05/28/2021
Mammography Problems at Advanced Women Imaging in Guttenberg, NJ: FDA Safety Communication (updated 2/7/23) 05/21/2021
Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication (updated 6/30/22) 05/20/2021
Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination: FDA Safety Communication 05/19/2021
Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction Differ in Complication Rates: FDA Safety Communication 03/31/2021
Mammography Problems at Tennessee Women’s Care P.C. in Nashville, TN: FDA Safety Communication 03/30/2021
Risk of Device Component Breaking in Patients with Stryker’s STAR Ankle: FDA Safety Communication 03/15/2021
Improper Use of Thermal Imaging Devices: FDA Safety Communication 03/04/2021
Pulse Oximeter Accuracy and Limitations: FDA Safety Communication 02/19/2021
Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication 01/04/2021



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