FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on February 23, 2022 - 21:34 GMT

Arrow International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola Percutaneous Thrombolytic Device Due to 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: Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Model Number: See Recall …

Distribution channels:

Published on February 19, 2022 - 02:44 GMT

Family Dollar Stores Issues Voluntary Recall of Certain FDA-Regulated Products in Six States Including Drugs, Devices, Cosmetics, ...

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:

Published on February 18, 2022 - 15:44 GMT

Baxter Issues Urgent Safety Communication to Reinforce Important Safety Information Regarding Upstream Occlusion Alarms for all ...

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 18, 2022 - 15:02 GMT

E25Bio Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False ...

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: E25Bio COVID-19 Direct Antigen Rapid Test; Trade …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 18, 2022 - 15:02 GMT

BASE10 Genetics Recalls RNAstill MTM Specimen Collection Kits That Are Not Authorized, Cleared, or Approved by the FDA, May Give ...

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: RNAstill MTM specimen collection kits Product Codes: See Recall Database Entry …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 17, 2022 - 18:13 GMT

Vyaire Medical Recalls bellavista 1000 and 1000e Series Ventilators Due to Issues with Software Configurations

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: Vyaire Medical Bellavista 1000 and 1000e Series Ventilators Product Codes: See …

Distribution channels:

Published on February 16, 2022 - 21:30 GMT

TCP HOT Acquisition LLC dba HRB Brands Issues Voluntary Nationwide Recall of Sure and Brut Aerosol Sprays 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 12, 2022 - 11:02 GMT

Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) Shortage - Letter to Health Care Providers

December 2, 2022 The U.S. Food and Drug Administration (FDA) is alerting health care facilities and providers of a shortage of Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices, including limited supplies of IAB catheters, new Cardiosave …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 11, 2022 - 06:35 GMT

Positive-Health Issues Voluntary Nationwide Recall of RISE UP RED EDITION 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:

Published on February 9, 2022 - 16:43 GMT

Celebrate Today Issues Voluntary Nationwide Recall of One Lot of Red Mammoth Due to the Presence of Undeclared Sildenafil 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 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