FDA Press Releases

• 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 11, 2022 - 14:16 GMT

  

  Teleflex Recalls Iso-Gard Filter S for Risk of Splitting or Detaching That May Cause Leakage and Insufficient Air Supply to ...

  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 Iso-Gard Filter S filters are breathing circuit bacterial filters that are connected to …

  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 8, 2022 - 11:05 GMT

  

  North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits That Are Not Authorized, Cleared, or Approved by ...

  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: Oral Rapid SARS-CoV-2 Rapid Antigen Test Kit, may also be called: Oral Rapid Test or …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 7, 2022 - 10:18 GMT

  

  Information Regarding Medically Necessary Specialty Infant Formulas: Notice to Health Care Providers

  July 1, 2022   The U.S. Food and Drug Administration is providing information to health care professionals to help their patients obtain access to medically necessary specialty, amino acid-based and metabolic infant formula products. The FDA is continuing …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 6, 2022 - 19:36 GMT

  

  Walmart Inc. Issues Voluntary Nationwide Recall of Various Artri Ajo King Joint Supplements Due to Potential Hidden Drug ...

  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 January 6, 2022 - 19:11 GMT

  

  Ukoniq (umbralisib): Drug Safety Communication - FDA Approval of Lymphoma Medicine is Withdrawn Due to Safety Concerns

  [Posted 06/01/2022]  AUDIENCE: Oncology, Patient, Health Professional, Pharmacy    ISSUE: Due to safety concerns, the FDA has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Updated findings from the UNITY-CLL clinical trial continued …

  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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