FDA Press Releases

• Published on June 21, 2022 - 18:00 GMT

  

  Draeger, Inc Recalls SafeStar 55 Breathing System Filters for Possible Obstructions That May Block Oxygen Flow 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  Product Name: SafeStar 55 Breathing System Filter Product Model Numbers: MP01790 Lot Number: …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 21, 2022 - 16:31 GMT

  

  FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for ...

  Date Issued: May 17, 2019 Audience: People with diabetes who use continuous glucose monitoring systems (CGMs), insulin pumps, or automated insulin dosing (AID) systems to manage their diabetes Health care providers treating or managing patients with …

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• Published on June 21, 2022 - 15:04 GMT

  

  UPDATE on Type III Endoleaks Associated with Endovascular Graft Systems – Letter to Health Care Providers

  On October 28, 2019, the FDA issued a Safety Communication to provide an update on Type III Endoleaks Associated with Use of Endologix AFX Endovascular AAA Graft Systems. October 15, 2018 - The FDA has issued a Class I recall to notify patients and health …

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• Published on June 15, 2022 - 00:33 GMT

  

  Latin Foods Market Issues Voluntary Nationwide Recall of Artri King Reforzado Con Ortiga Y Omega 3 Due to the 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 …

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• Published on June 12, 2022 - 13:14 GMT

  

  Update on Endologix AFX Endovascular AAA Graft Systems and Risk of Type III Endoleak: FDA Safety Communication

  Date Issued: December 6, 2022 The U.S. Food and Drug Administration (FDA) is updating our January 2022 safety communication on the use of Endologix AFX endovascular grafts used to treat patients with abdominal aortic aneurysm (AAA).  On December 6, 2022, …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 10, 2022 - 03:46 GMT

  

  Green Pharmaceuticals Inc Issues Voluntary Nationwide Recall of SnoreStop NasoSpray 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 …

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• Published on June 9, 2022 - 18:13 GMT

  

  Philips Respironics Alerts Customers Worldwide of Updated Instructions and Labeling of Specific Sleep Therapy Masks That Contain ...

  Summary Company Announcement Date: September 06, 2022 FDA Publish Date: September 06, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description potential risk of serious injury Company Name: Royal Philips’ subsidiary Philips …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 9, 2022 - 16:26 GMT

  

  Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain ...

  September 6, 2022 The U.S. Food and Drug Administration (FDA) is alerting health care providers that Philips Respironics (Philips) has recalled certain masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 9, 2022 - 16:24 GMT

  

  Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain ...

  Date Issued: September 6, 2022 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain masks used with bilevel positive airway pressure (also known as …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 8, 2022 - 16:48 GMT

  

  Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum ...

  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 June 8, 2022 - 12:57 GMT

  

  Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect

  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: HVAD Pump Implant Kit Models: 1101, 1103, 1104, 1104JP, MCS1705PU Distribution Dates: …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 7, 2022 - 15:06 GMT

  

  Buzzagogo, Inc. Issues Voluntary Nationwide Recall of Allergy Bee Gone for Kids Nasal Swab Remedy Due to Potential Microbial ...

  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 June 7, 2022 - 09:56 GMT

  

  Mylan Pharmaceuticals Inc., a Viatris Company, Issues Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin ...

  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 June 7, 2022 - 09:42 GMT

  

  Getinge USA Sales Inc Recalls Flow-c and Flow-e Anesthesia Systems for Cracked or Broken Suction System Power Switches

  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: Flow-c and Flow-e Anesthesia Systems Product Codes: 6887700, 6887900 Product Serial …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 27, 2022 - 13:40 GMT

  

  ArjoHuntleigh Polska Recalls Sara Plus Floor Lift for Risk of Smoke or Fire When Lift Is Used with Depleted Battery

  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: ArjoHuntleigh Polska Sara Plus floor lift Product Serial Numbers: See recall …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 26, 2022 - 15:29 GMT

  

  Abbott Medical Recalls Dragonfly OpStar Imaging Catheter for Potential Loose Catheter Marker Band That May Cause Patient Harm

  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: Dragonfly OpStar Imaging Catheter Product Lot Numbers: See recall database entry …

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• Published on May 25, 2022 - 19:15 GMT

  

  Urgent Voluntary Recall: CorneaGen Cornea/ Cornea Patch Grafts; CorneaGen is voluntarily recalling Corneal Patch Grafts bearing ...

  Firm: CorneaGen 1200 6th Ave Suite 300 Seattle, WA 98101 T: 206-701-5840 Product Numbers: W419221004861104; W419221004861105; W419221004861106; W419221004861103 On January 5, 2022, CorneaGen discovered that Cornea Patch Grafts were obtained from a donor …

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• Published on May 23, 2022 - 19:07 GMT

  

  Teva Issues Voluntary Nationwide Recall of One Lot of Anagrelide Capsules, USP 0.5 mg Due to Dissolution Test Failure

  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 May 19, 2022 - 21:18 GMT

  

  2022 Biologics Recalls

  The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 19, 2022 - 20:59 GMT

  

  Urgent Voluntary Recall: CorneaGen Sclera / Scleral Patch Grafts; CorneaGen is voluntarily recalling the entire lot of Scleral ...

  Firm: CorneaGen 1200 6th Ave Suite 300 Seattle, WA 98101 T: 206-701-5840 Lot Number: W419221008338 Product Numbers: W419221008338005; W419221008338006; W419221008338007; W419221008338008; W419221008338009; W419221008338010; W419221008338011; …

  Distribution channels: Healthcare & Pharmaceuticals Industry