FDA Press Releases

• Published on January 28, 2022 - 20:50 GMT

  

  Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication

  Date Issued: January 28, 2022 The U.S. Food and Drug Administration (FDA) is warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. These tests were distributed …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 28, 2022 - 20:50 GMT

  

  Empowered Diagnostics Recalls COVID-19 Tests due to Risk of False Results

  The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious adverse health consequences or death. Recalled Product  Empowered Diagnostics, LLC CovClear COVID-19 Rapid Antigen Test and ImmunoPass …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 28, 2022 - 17:02 GMT

  

  AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Polymyxin B for Injection USP, 500,000 Unit per Vial, Due to the ...

  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 January 27, 2022 - 22:01 GMT

  

  Blaine Labs Issues Voluntary Nationwide Recall of RevitaDerm Wound Care Gel Due to Bacterial Contamination

  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 January 26, 2022 - 19:51 GMT

  

  Philips Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked Questions

  In June 2021, Philips Respironics voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP), and continuous positive airway pressure (CPAP) machines due to potential health risks. The polyester- …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 26, 2022 - 19:51 GMT

  

  Philips Respironics Recalls Certain Trilogy EVO Ventilators for Potential Health Risks from PE-PUR Foam

  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 * Note: Trilogy 100 and 200 ventilators were previously recalled in June 2021 due to the same foam …

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• Published on January 21, 2022 - 14:52 GMT

  

  Medtronic Inc. Recalls HawkOne 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 HawkOne Directional Atherectomy System Product Codes and Lot Numbers: See Recall Database Entry …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 19, 2022 - 21:53 GMT

  

  UPDATE: Blood Specimen Collection Tube Conservation Strategies - Letter to Health Care and Laboratory Personnel

  January 19, 2022 The U.S. Food and Drug Administration (FDA) is aware the United States is experiencing significant interruptions in the supply of several blood specimen collection (blood draw) tubes because of an increase in demand during the COVID-19 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 19, 2022 - 19:43 GMT

  

  Getinge USA Sales, LLC Recalls the Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems Due to a 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: Vaporizer Sevoflurane, Maquet Filling for Flow Family Anesthesia Systems Model …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 19, 2022 - 16:26 GMT

  

  Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Recall of One Batch of Semglee® (insulin glargine injection), ...

  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 January 13, 2022 - 16:12 GMT

  

  Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems – FDA Safety Communication

  Date Issued: January 13, 2022 The U.S. Food and Drug Administration (FDA) is updating the December 2020 safety communication on the use of Endologix AFX endovascular grafts. This update includes a summary of information from our November 2021 advisory …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 12, 2022 - 18:42 GMT

  

  Buprenorphine: Drug Safety Communication - FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to ...

  [Posted 01/12/2022] AUDIENCE: Dentistry, Anesthesiology, Patient, Health Professional, Pharmacy ISSUE:  The FDA is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth.  The dental problems …

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• Published on January 12, 2022 - 18:42 GMT

  

  Lohxa LLC Issues Voluntary Nationwide Recall of Senna Syrup 8.8mg/5mL Due to Microbial Contamination

  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 January 12, 2022 - 17:06 GMT

  

  Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended- Release Tablets, USP 750 mg, Due to the ...

  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 January 12, 2022 - 15:40 GMT

  

  Oscor Inc. Issues Voluntary Worldwide Recall of Destino Twist Steerable Guiding Sheath Due to the Risk of the Device Hub Cap 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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 11, 2022 - 18:11 GMT

  

  2022 Safety Communications

  The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management. 2022 Safety Communications     Content current as of: …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 11, 2022 - 18:11 GMT

  

  Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication

  Date Issued: January 11, 2022 The U.S. Food and Drug Administration (FDA) is warning people to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test. The performance of these tests …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 10, 2022 - 16:07 GMT

  

  Cardiovascular Systems, Inc Recalls WIRION Embolic Protection Device Due to Complaints of Filter Breakage During Retrieval

  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: WIRION Embolic Protection Device Product Codes: …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 6, 2022 - 18:59 GMT

  

  Medtronic Recalls Synergy Cranial and StealthStation S7 Cranial Software Due to Potential Risk of Inaccurate Biopsy Depth Gauge ...

  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: Synergy Cranial and StealthStation S7 Cranial Software Model Numbers: See Recall …

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• Published on January 3, 2022 - 18:13 GMT

  

  2022 Medical Device Recalls

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