FDA Press Releases

• Published on August 31, 2023 - 17:11 GMT

  

  Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Gas Loss and Gas Gain ...

  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: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra- …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 31, 2023 - 17:11 GMT

  

  Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Power Failures When Device is ...

  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 Recalled Product: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra- …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 31, 2023 - 17:11 GMT

  

  Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Autofill Failure Alarms ...

  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 Recalled Product: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra- …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 31, 2023 - 17:10 GMT

  

  Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for System Over Temperature ...

  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 Recalled Product: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra- …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 31, 2023 - 17:10 GMT

  

  UPDATE: Risk of Device Failures for Getinge’s Maquet/Datascope Cardiosave Intra-Aortic Balloon Pump (IABP) – Letter to Health Care ...

  August 31, 2023 The U.S. Food and Drug Administration (FDA) is providing an update about device failures for Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices. The FDA is issuing this letter to help ensure …

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• Published on August 31, 2023 - 17:10 GMT

  

  Marlex Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Digoxin Tablets USP, 0.125mg and Digoxin Tablets USP, 0.25mg ...

  Summary Company Announcement Date: August 30, 2023 FDA Publish Date: August 31, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Label Mix-Up Company Name: Marlex Pharmaceuticals, Inc. Brand Name: Brand Name(s) Marlex …

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• Published on August 31, 2023 - 16:42 GMT

  

  Universal Meditech Inc. Issues Nationwide Recall of All Products Manufactured Between March 2021 and November 2022

  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 August 30, 2023 - 16:02 GMT

  

  Hamilton Medical Inc. Recalls HAMILTON-C1, C2, C3, T1 Ventilators for Software Issues that May Cause Ventilators to Stop Without ...

  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 Device Use Hamilton ventilators are used for people who require full or partial breathing …

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• Published on August 26, 2023 - 15:31 GMT

  

  Dr. Berne’s Whole Health Products Issues Voluntary Nationwide Recall of Dr. Berne’s MSM Drops 5% and 15% Solution Eye Drops Due to ...

  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 August 23, 2023 - 22:17 GMT

  

  Inmar Supply Chain Solutions, LLC, Issues a Voluntary Recall of Product Stored at its Arlington, Texas Facility Due to Conditions ...

  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 August 23, 2023 - 18:26 GMT

  

  Draeger Recalls Carina Sub-Acute Care Ventilators for Contaminants in Airpath

  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. Please be aware, this recall is a voluntary correction, not a product removal. Draeger will be updating affected …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 17, 2023 - 20:51 GMT

  

  Abiomed Recalls the Labeling for Impella RP Flex with SmartAssist for Risk of Blood Clots

  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. Please be aware, this recall is a voluntary correction, not a product removal. Recalled Product Product Names: …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 17, 2023 - 16:37 GMT

  

  Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for PCBA Failures Affecting the ...

  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:  Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra- …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 14, 2023 - 20:40 GMT

  

  Philips Respironics Recalls Trilogy Evo, Evo O2, EV300, and Evo Universal Ventilators After Finding Dust and Dirt in Air Path That ...

  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  Device Use Philips Respironics Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators provide …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 13, 2023 - 23:59 GMT

  

  Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Unexpected Shutdowns

  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 Recalled Product: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra- …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 13, 2023 - 23:59 GMT

  

  Do Not Use Tests Manufactured by Universal Meditech, Inc.: FDA Safety Communication

  Date Issued: August 11, 2023 The U.S. Food and Drug Administration (FDA) is warning consumers and patients to not use the following tests manufactured by Universal Meditech, Inc. (UMI):  One Step Pregnancy Test  DiagnosUS One Step Ovulation Test  …

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• Published on August 12, 2023 - 11:54 GMT

  

  Getinge Recalls CARDIOHELP Emergency Drive due to an Impaired or Inability to Turn the Drive

  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: CARDIOHELP Emergency Drive Product Codes: See Recall Database Entry Model Numbers: …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 9, 2023 - 18:40 GMT

  

  Church & Dwight Initiates Voluntary Recall of One Specific Lot of TheraBreath Kids Strawberry Splash 16oz Sold Exclusively on ...

  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 July 31, 2023 - 21:03 GMT

  

  Baxter Healthcare Corporation Recalls SIGMA Spectrum Infusion Pumps with Master Drug Library and Spectrum IQ Infusion Systems with ...

  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: SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) and Spectrum IQ …

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• Published on July 31, 2023 - 15:06 GMT

  

  Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of TydemyTM (Drospirenone, Ethinyl Estradiol and ...

  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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