The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Please be aware, this recall is a correction, not a product removal. Recalled Product Product Names: AirFit and AirTouch masks Product Codes: See Recall Database Entries: Model Numbers: AirFit…
Certain Type of Medicines Approved for Type 2 Diabetes and Obesity: Drug Safety Communication – Update on FDA’s Ongoing Evaluation of Reports of Suicidal Thoughts or Actions
[Posted 01/11/2024] AUDIENCE: Patient, Health Professional, Endocrinology, Pharmacy ISSUE: The FDA has been evaluating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1 receptor agonists. These medicines are used to treat people with type 2 diabetes or to help those with obesity or overweight to lose weight. FDA’s…
Insulet Corporation Recalls Omnipod 5 Android App due to a Software Error
Please be aware, this recall is a correction, not a product removal. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Omnipod 5 App (on compatible Android smartphones) Product Codes: QFG Software Version…
Megadyne Medical Products, Inc. Recalls Mega Soft Universal Patient Return Electrode Due to Reports of Patient Burns
Please be aware, this recall is a correction, not a product removal. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Megadyne Mega Soft Universal, Megadyne Mega Soft Universal Dual, Megadyne Mega Soft Universal…
Potential Exposure to Certain Chemicals with Use of GE HealthCare EVair and EVair03 Compressors with Certain Ventilators – Letter to Health Care Providers
January 9, 2024 The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities about the potential for exposure to certain chemicals that may be released when General Electric (GE) HealthCare accessory components called the EVair or EVair 03 (Jun-air) compressors are used with certain ventilators. Compressors are optional accessories for ventilators…
Leiters Health Issues Voluntary Nationwide Recall of Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags Due to Potential for Superpotent Drug
Summary Company Announcement Date: January 05, 2024 FDA Publish Date: January 08, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential for superpotent drug Company Name: Leiters Health Brand Name: Brand Name(s) Leiters, Compounding Health Product Description: Product Description Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags Company Announcement FOR IMMEDIATE…
Getinge / Atrium Medical Corporation Issues Medical Device Correction for Nurse Assist Syringes Provided with Express Drains
Summary Company Announcement Date: January 03, 2024 FDA Publish Date: January 04, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Syringes provided with Express Drains could not be verified to be sterile. Company Name: Getinge/Atrium Medical Corporation Brand Name: Brand Name(s) Product Description: Product Description Express Drains Company Announcement On December 13,…
Do Not Use Synovo Total Hip Resurfacing System: FDA Safety Communication
Date Issued: January 3, 2024 The U.S. Food and Drug Administration (FDA) is providing recommendations for health care providers considering using the Total Hip System, including resurfacing implants, manufactured by Synovo Production, Inc. (Synovo) and for patients who may have received certain implants used in the Synovo Total Hip System after 2019. Three components of…
2024 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. 2024 Safety Communications Content current as of: 01/03/2024 Article source: http://www.fda.gov/medical-devices/safety-communications/2024-safety-communications
HSV-2 Tests for Genital Herpes Can Produce False Reactive Results – Letter to Clinical Laboratory Staff and Health Care Providers
December 27, 2023 The U.S. Food and Drug Administration (FDA) is reminding health care providers and clinical laboratory staff about the potential for false reactive (false positive) results in herpes simplex virus type 2 (HSV-2) serological tests for genital herpes. Recommendations The FDA recommends that health care providers and clinical laboratory staff do the following:…