FDA Press Releases

• Published on November 30, 2021 - 05:00 GMT

  

  Teleflex Incorporated Announces Worldwide Recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR

  Summary Company Announcement Date: November 26, 2021 FDA Publish Date: November 30, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Inner lumen may detach from the device’s basket Company Name: Teleflex Incorporated …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on November 24, 2021 - 01:10 GMT

  

  P&G Issues Voluntary Recall of Specific Old Spice and Secret Aerosol Spray Antiperspirants and Old Spice Below Deck Aerosol Spray ...

  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 Summary Company …

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• Published on November 22, 2021 - 17:39 GMT

  

  Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Levetiracetam Injection, USP Due to Lack of Sterility Assurance

  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 November 19, 2021 - 20:44 GMT

  

  American Screening LLC issues a Voluntary Nationwide Recall of American Screening Hand Sanitizer Packaged in 8 oz Bottles Because ...

  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 November 18, 2021 - 05:01 GMT

  

  Odor-Eaters® Issues Voluntary Nationwide Recall of Specific Lots of Odor- Eaters® Spray Powder and Odor-Eaters® Stink Stoppers® ...

  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 November 17, 2021 - 21:05 GMT

  

  Leadless Pacing Systems: Risk of Major Complications Related to Cardiac Perforation During Implantation - Letter to Health Care ...

  November 17, 2021 The U.S. Food and Drug Administration (FDA) is reminding providers about the risk of major complications if cardiac perforation occurs during leadless pacemaker implantation. Cardiac perforation is a rare complication of any pacemaker …

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• Published on November 16, 2021 - 01:13 GMT

  

  SterRx, LLC Issues Voluntary Nationwide Recall of Certain SterRx Products

  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 Summary Company …

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• Published on November 12, 2021 - 20:19 GMT

  

  Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety ...

  Date Issued: 11/12/2021 The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication on Philips Respironics recalled ventilators, BiPAP, and CPAP machines. This update provides additional information on the recall and …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• 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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