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…
2021 Medical Device Recalls
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
Safety Recall for Deluxe Heat Therapy Massager
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…
Meitheal Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Cisatracurium Besylate Injection, USP 10mg per 5mL Due to Mislabeling
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…
Detección de cáncer de mama: el termograma no sustituye a la mamografía
Image English La Administración de Alimentos y Medicamentos de los EE. UU (FDA, por sus siglas en inglés) le recuerda que la mamografía (una imagen de rayos X de baja dosis de la mama) sigue siendo la prueba principal de detección de cáncer de mama más eficaz. Una prueba de detección adecuada del cáncer de…
Boston Scientific Announces LOTUS Edge™ Aortic Valve System Voluntary Recall and Product Discontinuation
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…
What Is Gene Therapy? How Does It Work?
[embedded content] Español The genes in your body’s cells play an important role in your health — indeed, a defective gene or genes can make you sick. Recognizing this, scientists have been working for decades on ways to modify genes or replace faulty genes with healthy ones to treat, cure or prevent a disease or…
Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2 – Letter to Clinical Laboratory Staff and Health Care Providers
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…
Fresenius Kabi Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter
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…
Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
Summary Company Announcement Date: January 04, 2021 FDA Publish Date: January 04, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA exceeds acceptable daily intake limit Company Name: Nostrum Laboratories Brand Name: Brand Name(s) Nostrum Laboratories Product Description: Product Description Metformin HCl Extended Release Tablets, USP 750 mg Company Announcement Nostrum Laboratories, Inc….