FDA Press Releases

• Published on March 21, 2024 - 18:44 GMT

  

  Vyaire Medical, Inc. Recalls AirLife Manual Resuscitators Due to Manufacturing Defect That Can Lead to Injury or Death

  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 and Codes:  AirLife™ Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask …

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• Published on March 21, 2024 - 14:56 GMT

  

  Abiomed Recalls the Instructions for Use for Impella Left Sided Blood Pumps due to Perforation Risks

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

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 20, 2024 - 20:46 GMT

  

  Voluntary Removal Announcement for the InfuTronix Nimbus Ambulatory Infusion Pump System

  Summary Company Announcement Date: March 20, 2024 FDA Publish Date: March 20, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Recall due to a high number (3698) of customer complaints related to the Nimbus Infusion …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 20, 2024 - 18:07 GMT

  

  Pyramid Wholesale Issues Recall of Various Brands of Products Sold as Dietary Supplements for Sexual Enhancement Because They ...

  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 March 19, 2024 - 18:45 GMT

  

  UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication

  Date Issued: March 19, 2024 The U.S. Food and Drug Administration (FDA) is providing an update on our ongoing evaluation of quality and performance issues related to plastic syringes made in China, and announcing additional recommendations and actions the …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 18, 2024 - 15:48 GMT

  

  Sleepnet Corporation Issues Worldwide Recall of CPAP and BIPAP Masks with Magnets Due to Potential Interference with Certain ...

  Summary Company Announcement Date: March 01, 2024 FDA Publish Date: March 18, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential interference with certain medical implants Company Name: Sleepnet Corporation …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 14, 2024 - 21:13 GMT

  

  Avanos Recalls MIC Gastric – Jejunal Feeding Tube Kits Containing Sterile Water Based Products Under Recall by Nurse Assist

  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 Avanos Medical MIC Gastric-Jejunal Feeding Tube and MIC Gastric-Jejunal Feeding Tube …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 12, 2024 - 21:04 GMT

  

  Par Pharmaceutical Issues Voluntary Nationwide Recall of One Lot of Treprostinil Injection Due to Potential for Silicone ...

  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 March 11, 2024 - 20:01 GMT

  

  Abbott Recalls HeartMate Touch Communication System for Unintentional Pump Start and Stop

  Please be aware, this recall is a correction, not a product removal.       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: …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 11, 2024 - 16:05 GMT

  

  Windstone Medical Packaging, Inc. Recalls Local Lower Extremity Pack, In House Ocular Pack and Closure Kit Containing Sterile ...

  Please be aware, this recall is a correction, not a product removal.  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 The Windstone …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 7, 2024 - 21:04 GMT

  

  Cardinal Health Recalls Sterile Monoject Luer-Lock and Enteral Syringes Due to a Change in Manufacturing

  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 Cardinal Health Monoject disposable syringes are used to inject fluid into or withdraw …

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• Published on March 7, 2024 - 19:56 GMT

  

  Ventec Life Systems Recalls VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) for Manufacturing Issue with Bonded ...

  Please be aware, this recall is a correction, not a product removal. 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: VOCSN Patient …

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• Published on March 7, 2024 - 17:35 GMT

  

  Medtronic Neurosurgery Recalls Duet External Drainage and Monitoring System Catheter Tubing due to a Potential for the Catheter ...

  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 The DUET External Drainage and Monitoring System (EDMS) is used for temporary drainage …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 6, 2024 - 19:29 GMT

  

  Baxter Healthcare Recalls ExactaMix Pro 1200 and Pro 2400 Due to a Software Error

  Please be aware, this recall is a correction, not a product removal. 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 The ExactaMix Pro …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 5, 2024 - 21:43 GMT

  

  Smiths Medical ASD Inc. Recalls Medfusion Model 3500 Syringe Pump Due to Issues Associated with Earlier Software Versions

  Please be aware, this recall is a correction, not a product removal. Recalled Product Product Names: Medfusion syringe pump Product Codes: FRN Model Numbers: Model 3500 syringe pump Distribution Dates: August 9, 2002 to August 15, 2023 Devices Recalled in …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 4, 2024 - 09:55 GMT

  

  Teleflex and Arrow International Recall ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits for ...

  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 Name: ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on February 29, 2024 - 20:21 GMT

  

  Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication

  Date Issued: February 29, 2024 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers about a higher-than-expected risk of device failure with the Hintermann Series H3 Total Ankle Replacement (TAR) system, …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on February 29, 2024 - 19:57 GMT

  

  Wipro GE Healthcare Private Ltd. Recalls Care Plus, Care Plus models 1000-4000 and Lullaby Incubators Due to Problems with Door ...

  Please be aware, this recall is a correction, not a product removal. 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: Care Plus, …

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• Published on February 29, 2024 - 19:32 GMT

  

  Megadyne Reiterates Intended Use Population Change for Megadyne Mega Soft Universal and Universal Plus Patient Return Electrodes

  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 February 29, 2024 - 18:24 GMT

  

  Follow Instructions for Safe Use of Electrical Operating Room Tables - Letter to Health Care Providers

  February 29, 2024 The U.S. Food and Drug Administration (FDA) is raising awareness among health care providers and facilities about the safe use of electrical operating room tables. The FDA has received reports of adverse events associated with electrical …

  Distribution channels: Healthcare & Pharmaceuticals Industry