October 13, 2021 The U.S. Food and Drug Administration (FDA) continues to monitor the risk of Nontuberculous mycobacteria (NTM) infections in patients who have undergone cardiothoracic surgery using heater-cooler devices, and to collaborate with …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
Date Issued: October 12, 2021 The U.S. Food and Drug Administration (FDA) is informing patients and health care providers about the potential for overdose, under certain clinical use conditions, when using ENFit low dose tip (LDT) syringes. The FDA is …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
The recall described in this notice is for the same issue that was announced in Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue FDA Safety Communication on October 5, 2021. The FDA has …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
Date Issued: September 29, 2021 The U.S. Food and Drug Administration (FDA) is warning consumers about the potential risk of injury associated with the use of the Safe-T-Lite UV WAND, manufactured by Max-Lux Corporation Limited. Use of Max-Lux Safe-T-Lite …
September 27, 2021 The U.S. Food and Drug Administration (FDA) is informing health care providers of recent information about the potential for differences in procedural outcomes between women and men undergoing implant of a left atrial appendage occlusion …
Summary Company Announcement Date: September 25, 2021 FDA Publish Date: September 26, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Loss of potency Company Name: Eli Lilly and Company Brand Name: Product Description: Product …
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 AMSORB PLUS PREFILLED G-CAN 1.0L Product Codes and Lot Numbers: See Recall Database Entry …
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 Cordis SUPER TORQUE MB Angiographic Catheter with Radiopaque Marker Bands Lot Numbers: See …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
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: Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield …
September 17, 2021 The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers of a potential for false positive results with the Alinity m SARS-CoV-2 AMP Kit, List Number 09N78-095, and Alinity m Resp-4-Plex …
Summary Company Announcement Date: September 16, 2021 FDA Publish Date: September 16, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description N-nitroso-varenicline above acceptable daily intake level Company Name: Pfizer Brand Name: …
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: NORMOFLO Irrigation Fluid Warmer and NORMOFLO Irrigation Warming Set Product Codes: …
September 15, 2021 The U.S. Food and Drug Administration (FDA) is reminding health care providers about the use of certain fluid warmers and the potential for aluminum leaching and exposing the patient to high levels of aluminum. Based on information …
DATE NOTIFICATION INITIATED: August 18, 2021 PRODUCT / LOT NUMBER: Level 1® Fluid Warmer Model Numbers: H-1000, H-500 Level 1® Fluid Warming System Model Numbers: H-1028, H-1200 NORMOFLO® Fluid Warmer Model Number: H-1025 Level 1® Normothermic I.V. Fluid …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
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 (Include the following information) Product Names: Custom Convenience Kits containing the Cardinal …
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