[Posted 02/04/2021] AUDIENCE: Patient, Health Professional, Pharmacy, Rheumatology, Gastroenterology, Cardiology, Oncology  ISSUE: The FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to another type of medicine called tumor necrosis…

Summary Company Announcement Date: February 02, 2021 FDA Publish Date: February 03, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Packaging error resulting in incorrect dosage listed Company Name: Apotex Corp Brand Name: Brand Name(s) Apotex Corp. Product Description: Product Description Enoxaparin Sodium Injection, USP Company Announcement Apotex Corp is voluntarily recalling two…

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 Products EMBLEM S-ICD Subcutaneous Electrode Model Number: 3501 Manufacturing Dates: March 2016 and November 2020 Distribution Dates: June 2017 to November 2020 Devices Recalled in the U.S.: 19,919…

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 Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology, also known as JET 7 Xtra Flex All Lots Model or Catalog Numbers: The FDA’s Recall Classification Database…

The list below contains recalls that were issued in 2021. 2021 Medical Device Recalls Content current as of: 01/29/2021 Regulated Product(s) Article source: http://www.fda.gov/medical-devices/medical-device-recalls/2021-medical-device-recalls

Summary Company Announcement Date: January 28, 2021 FDA Publish Date: January 28, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Can overheat causing smoke or spark, which may pose a fire hazard Company Name: Wahl Clipper Corporation Brand Name: Brand Name(s) Product Description: Product Description Deluxe Heat Therapy Massagers, Model 4212 Company…

Summary Company Announcement Date: January 27, 2021 FDA Publish Date: January 27, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeling Company Name: Meitheal Pharmaceuticals, Inc. Brand Name: Brand Name(s) Meitheal Pharmaceuticals, Inc. Product Description: Product Description Cisatracurium Besylate Injection, USP 10mg per 5mL Company Announcement Meitheal Pharmaceuticals, Inc. (“Meitheal”), announced today that…

Summary Company Announcement Date: January 11, 2021 FDA Publish Date: January 11, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Delivery System Issues Potential inability to release the delivery system Company Name: Boston Scientific Corporation Brand Name: Brand Name(s) LOTUS Edge™ Aortic Valve System Product Description: Product Description LOTUS Edge™ Aortic Valve…

January 8, 2021 The SARS-CoV-2 virus can mutate over time, resulting in genetic variation in the population of circulating viral strains. The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false negative results may occur with any molecular test for the detection of SARS-CoV-2 if a mutation…

Summary Company Announcement Date: January 08, 2021 FDA Publish Date: January 08, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter Company Name: Fresenius Kabi USA Brand Name: Brand Name(s) Fresenius Kabi Product Description: Product Description Ketorolac Tromethamine Injection, USP, 30 mg/mL Company Announcement Fresenius Kabi USA is voluntarily recalling…