FDA Press Releases

• Published on February 8, 2022 - 19:26 GMT

  

  ABC SALES 1 INC Issues Voluntary Nationwide Recall of MAC DADDY RED and MAC DADDY PURPLE Capsules 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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on February 8, 2022 - 18:27 GMT

  

  Potential Risk of Strangulation in Children who Use Enteral Feeding Delivery Sets

  Date Issued: February 8, 2022 The U.S. Food and Drug Administration (FDA) is warning health care providers, parents and caregivers of pediatric patients (children) who receive enteral feeding that there is a risk of strangulation from the use of enteral …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on February 8, 2022 - 16:37 GMT

  

  Your Favorite Shop Issues Voluntary Nationwide Recall of the Red Pill Capsules, Due to the Presence of Undeclared Tadalafil

  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 February 8, 2022 - 15:19 GMT

  

  Distributor RFR, LLC, Voluntary Nationwide Recall of Sangter Energy Supplement Due to Presence of Undeclared Sildenafil

  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 February 6, 2022 - 16:08 GMT

  

  Baxter Issues Urgent Medical Device Correction to Reinforce Important Safety Information Regarding Possible Risk of Oxygen ...

  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 6, 2022 - 13:05 GMT

  

  Illumina Cybersecurity Vulnerability May Present Risks for Patient Results and Customer Networks: Letter to Health Care Providers

  June 2, 2022 The U.S. Food and Drug Administration (FDA) is informing laboratory personnel and health care providers about a cybersecurity vulnerability affecting software in the Illumina NextSeq 550Dx, the MiSeqDx, the NextSeq 500, NextSeq 550, MiSeq, …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on February 6, 2022 - 11:19 GMT

  

  Atrium Medical Corporation Recalls iCast Covered Stent for Potential Balloon or Catheter Hub Separation That May Cause Patient ...

  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: iCast Covered Stent Product Lot Numbers: See recall database entry Distribution Dates …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on February 6, 2022 - 10:23 GMT

  

  UPDATE: FDA Updates Recommendations for the Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety ...

  Date Issued: June 2, 2022 The U.S. Food and Drug Administration (FDA) is updating our safety communication issued in March 2022 to inform consumers and health care providers about a new handpiece for the Apyx Renuvion/J-Plasma device system that can be …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on February 5, 2022 - 17:57 GMT

  

  Philips Respironics Issues Voluntary Recall Notification/Field Safety Notice* for the V60 Ventilator Product Family

  Summary Company Announcement Date: April 22, 2022 FDA Publish Date: May 02, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description A potential issue with the electrical circuit in these ventilators that controls the 35V power …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on February 5, 2022 - 12:42 GMT

  

  Fagron Inc. Issues Voluntary Nationwide Recall of SyrSpend SF Cherry 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 February 4, 2022 - 21:06 GMT

  

  SD BIOSENSOR, Issues Notification of Voluntary Recall of ‘STANDARD Q COVID-19 Ag Home Test’

  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 February 4, 2022 - 20:16 GMT

  

  Vyaire Medical Issues Voluntary Correction for Certain bellavista™ Ventilators in Specific Software Configurations

  Summary Company Announcement Date: February 04, 2022 FDA Publish Date: February 04, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Ventilators can cease ventilation and generate a technical failure alarm 305 Company …

  Distribution channels:
• Published on February 4, 2022 - 19:26 GMT

  

  Junp LLC Issues Voluntary Nationwide Recall of MegMan Performance Booster Capsules Due to the Presence of Tadalafil

  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 February 4, 2022 - 17:49 GMT

  

  Do Not Use E25Bio COVID-19 Tests: FDA Safety Communication

  Date Issued: February 4, 2022 The U.S. Food and Drug Administration (FDA) is warning people not to use the E25Bio COVID-19 Direct Antigen Rapid Test. This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on February 3, 2022 - 16:00 GMT

  

  Ukoniq (umbralisib): Drug Safety Communication - FDA Investigating Possible Increased Risk of Death with Lymphoma

  [Posted 02/03/2022]  AUDIENCE: Oncology, Patient, Health Professional, Pharmacy    ISSUE: The FDA is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib) approved to treat two specific types of lymphomas, which are …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 31, 2022 - 17:43 GMT

  

  Esupplementsales, LLC Issues a Nationwide Recall All Lots of Hard Dawn Due to the Presence of Undeclared Tadalafil

  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 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 …

  Distribution channels:
• 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