FDA Press Releases

• Published on October 29, 2021 - 18:53 GMT

  

  Datascope/Getinge/Maquet Recalls Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs Due to Risk of Battery Failure

  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  Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs Product Codes and Lot Numbers: …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on October 29, 2021 - 18:00 GMT

  

  Zimmer Biomet Recalls ROSA One 3.1 Brain Application Due to Error in Software

  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  ROSA One 3.1 Brain Application Product Codes and Lot Numbers: See Recall Database Entry  Devices …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on October 27, 2021 - 22:34 GMT

  

  Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Cardinal Health’s Monoject™ Flush Prefilled ...

  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 …

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• Published on October 27, 2021 - 17:40 GMT

  

  artnaturals® Issues Voluntary Recall of Limited Batches of 8oz Bottles of Scent Free Hand Sanitizer Due to Presence of Impurities

  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 …

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• Published on October 20, 2021 - 21:00 GMT

  

  Merck Issues Voluntary Nationwide Recall of CUBICIN® (Daptomycin for Injection) 500 mg, Lot 934778, Due to Presence of Particulate ...

  Summary Company Announcement Date: October 19, 2021 FDA Publish Date: October 20, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains particulate matter identified as glass Company Name: Merck Brand Name: Product …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on October 19, 2021 - 19:54 GMT

  

  Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Methocarbamol 500mg Bottles Due to Mislabeling With the Incorrect ...

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on October 19, 2021 - 17:29 GMT

  

  Cook Medical Issues Voluntary Recall of Transseptal Needle and Transseptal Needle with Catheter

  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 …

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• Published on October 14, 2021 - 18:33 GMT

  

  Abbott Molecular, Inc. Recalls Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit for Potential False Positive SARS-...

  The recall described in this notice is due to the same issue that was announced in the September 17, 2021 Letter to Health Care Providers: Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on October 14, 2021 - 16:03 GMT

  

  Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of All Irbesartan Tablets and Irbesartan and Hydrochlorothiazide ...

  Summary Company Announcement Date: October 14, 2021 FDA Publish Date: October 14, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description API batches above the specification limit for the impurity, N-nitrosoirbesartan Company Name: …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on October 13, 2021 - 16:48 GMT

  

  UPDATE: Potential Risk of Infection When Using Heater-Cooler Devices – Letter to Health Care Providers

  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 …

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• Published on October 13, 2021 - 00:41 GMT

  

  Teligent Pharma, Inc.’s Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution 4% Due to Super Potency

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on October 12, 2021 - 17:27 GMT

  

  Potential for Medication Overdose with ENFit Low Dose Tip Syringe: FDA Safety Communication

  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 …

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• Published on October 12, 2021 - 16:35 GMT

  

  Efficient Laboratories, Inc. Expands Voluntary Nationwide Recall to Consumers to Include Twelve Additional Lots of Rompe Pecho CF, ...

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on October 11, 2021 - 10:06 GMT

  

  Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 30, 2021 - 23:13 GMT

  

  Coppertone® Issues Voluntary Nationwide Recall of Specific Lots of Pure & Simple SPF 50 Spray (2021 Launch), Sport Mineral SPF 50 ...

  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 …

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• Published on September 29, 2021 - 18:27 GMT

  

  Risk of Exposure to Unsafe Levels of Radiation with Safe-T-Lite UV WAND: FDA Safety Communication

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 27, 2021 - 16:09 GMT

  

  Left Atrial Appendage Occlusion (LAAO) Devices Potentially Associated with Procedural Outcome Differences Between Women and Men – ...

  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 …

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• Published on September 27, 2021 - 01:23 GMT

  

  Eli Lilly and Company Issues Voluntary Nationwide Recall of One Lot of GLUCAGON® Emergency Kit Due to Loss of Potency

  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 …

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• Published on September 23, 2021 - 18:32 GMT

  

  Armstrong Medical Limited Recalls AMSORB PLUS PREFILLED G-CAN 1.0L Due to Reduced Gas Flow to Patients During Anesthesia

  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  …

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• Published on September 22, 2021 - 21:41 GMT

  

  Cordis Recalls SUPER TORQUE MB Angiographic Catheter with Radiopaque Marker Bands Due to Potential for Marker Bands to Move or ...

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry