FDA Press Releases

• 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 4, 2022 - 19:04 GMT

  

  Best Brand Consumers Products, Inc. Issues Voluntary Recall of Mickey Mouse Hand Sanitizer Ethyl Alcohol 68% Due to Presence of ...

  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 4, 2022 - 17:49 GMT

  

  F&S Medical Supply, DBA Pink Toyz Issues Voluntary Nationwide Recall of Pink Pussycat Capsules Due to the Presence of Undeclared ...

  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 3, 2022 - 18:13 GMT

  

  2022 Medical Device Recalls

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

  

  Covidien, LP Recalls Puritan Bennett 980 Series Ventilator Due to Manufacturing Assembly Error

  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: Puritan Bennett 980 Series Ventilator Model Numbers: See Recall Database Entries  …

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• Published on January 3, 2022 - 15:05 GMT

  

  Do Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication

  Date Issued: March 1, 2021 The U.S. Food and Drug Administration (FDA) is warning people not to use certain ACON Laboratories COVID-19 tests.  People should not use the ACON Laboratories test named “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 3, 2022 - 13:31 GMT

  

  Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests: FDA Safety Communication

  Date Issued: March 1, 2022 The U.S. Food and Drug Administration (FDA) is warning people not to use the SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test. The test is not authorized, cleared, or approved by the FDA for distribution or use in the United …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 3, 2022 - 12:03 GMT

  

  Do Not Use Certain Celltrion DiaTrust COVID-19 Tests: FDA Safety Communication

  Date Issued: March 1, 2022 The U.S. Food and Drug Administration (FDA) is warning people not to use certain Celltrion USA Inc. DiaTrust COVID-19 Ag Rapid Tests. People should not use the Celltrion DiaTrust COVID-19 Ag Rapid Test that is in green and white …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on December 30, 2021 - 15:31 GMT

  

  Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Clobetasol Propionate Ointment USP, 0.05%, 60 g Tubes, Lot ...

  Summary Company Announcement Date: December 27, 2021 FDA Publish Date: December 30, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Ralstonia pickettii bacteria Company Name: Taro Pharmaceuticals USA, Inc. Brand Name …

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• Published on December 27, 2021 - 20:51 GMT

  

  Padagis Issues Voluntary Nationwide Recall for Nitroglycerin Lingual Spray Due to a Possible Defective Delivery System

  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 December 22, 2021 - 18:55 GMT

  

  Getinge’s Maquet/Datascope IABP Devices: Update on Device Failure – Letter to Health Care Providers

  December 22, 2021 The U.S. Food and Drug Administration (FDA) is providing updated information about our ongoing evaluation and monitoring of device failures associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices, including …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on December 17, 2021 - 21:41 GMT

  

  Possible False RPR Reactivity with BioPlex 2200 Syphilis Total & RPR Test Kit Following a COVID-19 Vaccine - Letter to Clinical ...

  December 17, 2021 The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false reactivity, or "false-positive", Rapid Plasma Reagin (RPR; non-treponemal) test results, when using the Bio- …

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• Published on December 16, 2021 - 14:28 GMT

  

  Getinge/Datascope/Maquet Recalls Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Due to Reports of Fluid ...

  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: Datascope/Getinge/Maquet Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on November 30, 2021 - 05:00 GMT

  

  Teleflex Incorporated Announces Worldwide Recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR

  Summary Company Announcement Date: November 26, 2021 FDA Publish Date: November 30, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Inner lumen may detach from the device’s basket Company Name: Teleflex Incorporated …

  Distribution channels: Healthcare & Pharmaceuticals Industry