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: Twin Tube Product Codes: BZC Model Numbers: V-707327 Distribution Dates: January 1, 2015 to June 30, 2023 Devices Recalled in the U.S.: 649 Date Initiated…

Summary Company Announcement Date: May 21, 2024 FDA Publish Date: May 22, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Potential Packaging Defect Company Name: Hospira Inc. Brand Name: Brand Name(s) Product Description: Product Description Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units Company…

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 Name: HeartMate 3 Left Ventricular Assist System Implant Kit Product Codes: See Recall…

Please be aware, this recall is a correction, not a product removal. Philips Respironics is providing a software update for its Trilogy Evo continuous ventilators. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices without the software update may cause serious injuries or death….

Date Issued: May 13, 2024 The U.S. Food and Drug Administration (FDA) is warning home test users, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests for Home and Over-the-Counter (OTC) Use and its COVID-19 Test intended for patient care settings due to increased risk of false results. Recommendations for Home Test…

May 8, 2024 The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities about our continued safety and quality concerns with the following Getinge/Maquet cardiovascular medical devices: Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and Getinge/Maquet Cardiohelp system and HLS Sets. The FDA recommends that health care facilities…

Summary Company Announcement Date: May 10, 2024 FDA Publish Date: May 10, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Reports of patient burn injuries Company Name: Megadyne Medical Products Inc. Brand Name: Brand Name(s) Ethicon Megadyne Product Description: Product Description Mega Soft Pediatric Patient Return Electrode Company Announcement Cincinnati, OH –…

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: Product Codes: QJP, DQY, NRY Model Numbers: K190431 Route 92 Medical Delivery Catheter (DQY), also known as Tenzing 7 and sold separately. K203043 Route 92…

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: Version 2.7 of the Apple iOS t:connect mobile app used in conjunction with…

Summary Company Announcement Date: April 22, 2024 FDA Publish Date: April 23, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Product is tainted with Nortadalafil Company Name: STOP CLOPEZ CORP Brand Name: Brand Name(s) Product Description: Product Description Herbal Dietary Supplement Company Announcement FOR IMMEDIATE RELEASE – 04/22/2024– Hollywood, FL, US, STOP CLOPEZ…