FDA Press Releases

• Published on July 28, 2023 - 11:32 GMT

  

  GE HealthCare Recalls TruSignal SpO2 Sensors for Issues That May Reduce Defibrillation Energy, Expose Patients to Unintended ...

  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:  TruSignal Adult Pediatric Sensor  TruSignal AllFit Sensor  TruSignal Sensitive …

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• Published on July 27, 2023 - 13:06 GMT

  

  Abiomed Recalls All Impella Left Sided Blood Pumps for Risk of Motor Damage After Contact with Transcatheter Aortic Valve ...

  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 and …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 26, 2023 - 14:46 GMT

  

  Abbott Recalls Amplatzer Steerable Delivery Sheath for Increased Risk of Air Embolism

  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: Amplatzer Steerable Delivery Sheath  Product Model: ASDS-14F-075 Distribution Dates: …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 19, 2023 - 15:09 GMT

  

  Use Alternative Testing Method for the Quidel Cardiovascular Inc. Quidel Triage Cardiac Panel - Letter to Health Care Providers

  July 19, 2023 The U.S. Food and Drug Administration (FDA) is recommending health care providers, laboratory personnel, and facilities stop using the Quidel Triage Cardiac Panel, manufactured by Quidel Cardiovascular Inc. (QuidelOrtho). On May 25, 2023, …

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• Published on July 18, 2023 - 13:31 GMT

  

  Medtronic Recalls Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) ...

  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:  Cobalt XT, Cobalt, Crome ICDs and CRT-Ds Claria MRI, Amplia MRI, Compia MRI, Viva, …

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• Published on July 17, 2023 - 15:29 GMT

  

  Do Not Use RoyalVibe Health, CellQuicken, or Well-Being Reality Ultrasound Medical Devices: FDA Safety Communication

  Date Issued: July 17, 2023 The U.S. Food and Drug Administration (FDA) is warning consumers not to use ultrasound medical devices manufactured and distributed by RoyalVibe Health, CellQuicken, or Well-Being Reality. The devices have not been reviewed by …

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• Published on July 17, 2023 - 13:16 GMT

  

  Quidel Cardiovascular Inc. Recalls Quidel Triage Cardiac Panels for Risk of False Negative Troponin Results that Could Cause ...

  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: Quidel Triage Cardiac Panel Quidel Triage Cardiac Panel, Troponin I Quidel Triage …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 13, 2023 - 18:10 GMT

  

  NOxBOX Ltd. Recalls NOxBOXi Nitric Oxide System for Manifold Failure that May Cause Gas Leaks and Interrupt Therapy to Neonates

  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: NOxBOXi Nitric Oxide Delivery System Product Serial Numbers: See Recall Database …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 13, 2023 - 18:10 GMT

  

  Draeger Medical Recalls Oxylog 3000 Plus Emergency and Transport Ventilators for Risk of Unexpected Depleted Battery and ...

  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: Oxylog 3000 Plus Emergency and Transport Ventilator Part Numbers: 5704811 and …

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• Published on July 11, 2023 - 21:04 GMT

  UPDATE: Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease Unlikely to Increase Risk of Mortality - Letter to Health ...

  Available data no longer supports a probable late mortality risk associated with paclitaxel-coated devices used to treat femoropopliteal disease.

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 11, 2023 - 15:36 GMT

  UPDATE: Risk of Mortality Associated with Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease is No Longer Supported ...

  Available data no longer supports a probable late mortality risk associated with paclitaxel-coated devices used to treat femoropopliteal disease.

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 11, 2023 - 14:30 GMT

  

  Megadyne Recalls MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes for Risk of Serious Burn Injuries to Patients

  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 MEGA 2000 (Figure 1) and MEGA SOFT (Figure 2) Reusable Patient Return Electrodes are …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 9, 2023 - 15:58 GMT

  

  Hua Da Trading Inc dba Wefun Inc Issues Voluntary Nationwide Recall of WEFUN Capsules Due to Presence of Undeclared Sildenafil

  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 7, 2023 - 13:40 GMT

  

  Cipla Issues Voluntary Nationwide Recall of Six Batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) ...

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 28, 2023 - 15:27 GMT

  

  UPDATE: NuVasive Specialized Orthopedics’ Precice Devices - Letter to Health Care Providers

  June 28, 2023 The U.S. Food and Drug Administration (FDA) is providing an update to information and recommendations for the NuVasive Specialized Orthopedics’ (NuVasive) Precice Intra-medullary Limb Lengthening (IMLL) system, which includes Precice Short.  …

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• Published on June 26, 2023 - 16:45 GMT

  

  Teleflex and Arrow International Recall ARROW Endurance Extended Dwell Peripheral Catheter System for Risk of Catheter Separation ...

  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 Endurance Extended Dwell Peripheral Catheter System Product Codes: See Recall …

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• Published on June 14, 2023 - 15:55 GMT

  

  The Harvard Drug Group, LLC Issues Voluntary Nationwide Recall of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride ...

  Summary Company Announcement Date: June 13, 2023 FDA Publish Date: June 14, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Packaging may contain incorrect product due to labeling mix-up Company Name: The Harvard Drug Group, LLC …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 12, 2023 - 15:28 GMT

  

  BearCare, Inc. Recalls Rechargeable Walnut Wearable Smart Thermometers for Risks of Serious Injury, including Burns During Use

  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: Walnut Wearable Smart Thermometer Product Model Number: WT20 Product Lot Number: …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 11, 2023 - 17:04 GMT

  

  Do Not Use Certain Brands of Saline and Sterile Water Medical Products by Nurse Assist Because They May Not Be Sterile: FDA Safety ...

  Date Issued: November 6, 2023 The U.S. Food and Drug Administration (FDA) is warning consumers, health care providers, and health care facilities not to use recalled saline (0.9% sodium chloride) and sterile water medical products manufactured by Nurse …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 11, 2023 - 16:13 GMT

  

  Nurse Assist, LLC Issues Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP Nationwide and 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 Summary Company …

  Distribution channels: Healthcare & Pharmaceuticals Industry