FDA Press Releases

• Published on March 18, 2022 - 14:37 GMT

  

  Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm: FDA Safety Communication

  Date Issued: March 18, 2022 The U.S. Food and Drug Administration (FDA) is alerting people that there is a potential for harm if FDA authorized at-home COVID-19 tests are not used according to the manufacturer’s test instructions. The FDA is also reminding …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 17, 2022 - 16:50 GMT

  

  Celltrion USA Recalls Certain Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf ...

  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: Celltrion DiaTrust COVID-19 Ag Rapid Test  Product Code: 83QKP Lot Numbers: See …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 17, 2022 - 01:10 GMT

  

  SD Biosensor Recalls STANDARD Q COVID-19 Ag Home Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False ...

  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: SD Biosensor STANDARD Q COVID-19 Ag Home Test Product Codes and Lot Numbers: See …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 15, 2022 - 19:59 GMT

  

  Celltrion USA Recalls Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life

  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: Celltrion DiaTrust COVID-19 Ag Rapid Test  Product Code: 83QKP Lot Numbers: See …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 14, 2022 - 17:19 GMT

  

  LuSys Laboratories, Inc Recalls COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests Because They Are Not ...

  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: COVID-19 Antigen Test (Saliva) COVID-19 Antigen Test (Nasal) COVID-19 IgG/IgM …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 14, 2022 - 15:37 GMT

  

  FDA Warns Against Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication

  Date Issued: March 14, 2022 The U.S. Food and Drug Administration (FDA) is warning consumers and health care providers against the use of the Renuvion/J-Plasma device by Apyx Medical for certain aesthetic procedures. Specifically, the FDA is warning …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 11, 2022 - 23:17 GMT

  

  ACON Laboratories Issues a Recall of Non-EUA Authorized “Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-Testing)” Tests From the U....

  Summary Company Announcement Date: January 09, 2022 FDA Publish Date: March 11, 2022 Product Type: Medical Devices Counterfeit Reason for Announcement: Recall Reason Description Unauthorized U.S. distribution-counterfeited product Company Name: ACON …

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• Published on March 11, 2022 - 19:23 GMT

  

  Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ ...

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

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• Published on March 11, 2022 - 11:03 GMT

  

  Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition: FDA Safety Communication

  Date issued: 11/3/2022 The U.S. Food and Drug Administration (FDA) recommends that parents and caregivers do not use infant head shaping pillows intended to change an infant’s head shape or symmetry or claim to prevent or treat any medical condition. The …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 11, 2022 - 00:26 GMT

  

  Olympia Pharmacy Issues Voluntary Nationwide Recall of Seven Compounded Products Due to Being Out-of-Specification

  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 March 9, 2022 - 14:56 GMT

  

  Medtronic Recalls TurboHawk Plus Directional Atherectomy System Due to Risk of Tip Damage 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  Device Use The TurboHawk Plus Directional Atherectomy System consists of a catheter and a cutter …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 8, 2022 - 04:51 GMT

  

  Tennessee Technical Coatings Corp Issues Nationwide Voluntary Recall of Hand Sanitizer Isopropyl Alcohol Antiseptic 75% 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 March 7, 2022 - 21:38 GMT

  

  Fresenius Kabi Issues Voluntary Recall of Sodium Acetate Injection, USP Due to the Presence of Particulate Matter

  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 6, 2022 - 12:53 GMT

  

  Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or 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  Product Name: Philips Respironics V60 and V60 Plus Ventilator   Product Codes and Serial Numbers  …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 3, 2022 - 23:08 GMT

  

  B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride for Injection USP 250ML in Excel Due to Fluid ...

  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 February 28, 2022 - 15:19 GMT

  

  FDA Advisory Panel Recommendations on Lifelong Surveillance and Long-Term Postmarket Data Collection for Patients with AAA ...

  The U.S. Food and Drug Administration (FDA) is emphasizing to physicians and other health care providers the importance of lifelong surveillance, including imaging, for patients with abdominal aortic aneurysm (AAA) endovascular aortic repair (EVAR). …

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• Published on February 23, 2022 - 21:34 GMT

  

  Arrow International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola Percutaneous Thrombolytic Device Due to Risk of ...

  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: Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Model Number: See Recall …

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• Published on February 19, 2022 - 02:44 GMT

  

  Family Dollar Stores Issues Voluntary Recall of Certain FDA-Regulated Products in Six States Including Drugs, Devices, Cosmetics, ...

  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 February 18, 2022 - 15:44 GMT

  

  Baxter Issues Urgent Safety Communication to Reinforce Important Safety Information Regarding Upstream Occlusion Alarms for all ...

  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 February 18, 2022 - 15:02 GMT

  

  E25Bio Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False ...

  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 (Include the following information) Product Names: E25Bio COVID-19 Direct Antigen Rapid Test; Trade …

  Distribution channels: Healthcare & Pharmaceuticals Industry