FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on February 24, 2021 - 04:42 GMT

Medtronic Announces Voluntary Recall of Unused Valiant Navion™ Thoracic Stent Graft System

Summary Company Announcement Date: February 23, 2021 FDA Publish Date: February 23, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to endoleaks, stent fractures and stent ring enlargement Company Name: Medtronic …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 22, 2021 - 23:55 GMT

Hillrom Recalls Liko Multirall 200 Overhead Lift Due to Failure to Properly Attach Q-Link Strap Lock (Also Known as Q-Link 1 Strap ...

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 Products Hillrom Liko Multirall 200 Overhead Lift Model Number, Product Codes, Catalog or Lot numbers: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 20, 2021 - 07:55 GMT

Boston Scientific Corporation Recalls EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System 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 (Include the following information) EMBLEM S-ICD (Subcutaneous Implantable Cardioverter …

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Published on February 20, 2021 - 07:53 GMT

Pulse Oximeter Accuracy and Limitations: FDA Safety Communication

Date Issued: February 19, 2021 The Coronavirus Disease 2019 (COVID-19) pandemic has caused an increase in the use of pulse oximeters, and a recent report (Sjoding et al.) suggests that the devices may be less accurate in people with dark skin pigmentation. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 17, 2021 - 07:47 GMT

Adamssecret.co Issues Voluntary Nationwide Recall of Adam’s Secret Extra Strength 1500 and 3000 Capsules 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 February 12, 2021 - 13:16 GMT

Sandoz, Inc. Issues Nationwide Recall of One Lot of Enoxaparin Sodium Injection, USP 40mg/0.4 mL Due to Temperature Excursion ...

Summary Company Announcement Date: December 01, 2021 FDA Publish Date: December 02, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Exposure to high temperatures may have impacted product effectiveness. Company Name: Sandoz, Inc …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 11, 2021 - 11:20 GMT

Alcohol-based Hand Sanitizer: Drug Safety Communication - Getting in the Eyes Can Cause Serious Injury

[Posted 11/02/2021] AUDIENCE: Consumer, Health Professional, Pharmacy, Pediatrics, Caregivers    ISSUE: The FDA is warning that getting alcohol-based hand sanitizer in the eyes from splashing or touching the eyes after use of hand sanitizer can result in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 9, 2021 - 18:45 GMT

Using Ventilator Splitters During the COVID-19 Pandemic - Letter to Health Care Providers

The U.S. Food and Drug Administration (FDA) is informing health care providers and health care facilities about up-to-date information concerning multiplexing ventilator tubing connectors, also known as ventilator splitters, in situations in which no …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 9, 2021 - 13:38 GMT

Janus Kinase (JAK) inhibitors: Drug Safety Communication - FDA Requires Warnings about Increased Risk of Serious Heart-related ...

AUDIENCE: Patient, Rheumatology, Gastroenterology, Cardiology, Neurology, Oncology, Pharmacy, Health Professional  ISSUE: The FDA is requiring revisions to the Boxed Warning, FDA’s most prominent warning, for Xeljanz/Xeljanz XR (tofacitinib), Olumiant ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 9, 2021 - 12:20 GMT

Magellan Diagnostics, Inc. Expands Voluntary Recall of LeadCare® Test Kits

Summary Company Announcement Date: September 01, 2021 FDA Publish Date: September 02, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description LeadCare Test Kits lots could potentially underestimate blood lead levels when …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 8, 2021 - 16:05 GMT

BD to Begin Remediation for BD Alaris™ System Software

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 7, 2021 - 13:19 GMT

Medtronic Vascular Recalls Angiographic Guidewire Component Due to Being Non-sterile

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 Angiographic Guidewire Component Model Numbers: WIRE ANGIO 107042 PNS .035X145 3MMJ PTFE; Part No …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 6, 2021 - 11:05 GMT

The Biomed Guys Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts

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 Alaris Infusion Pump Module Model 8100 Bezel, purchased and/or installed by The Biomed Guys Models: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 4, 2021 - 19:46 GMT

Apotex Corp. Issues Voluntary Nationwide Recall of Enoxaparin Sodium Injection, USP Due to Mislabeling of Syringe Barrel ...

Summary Company Announcement Date: February 02, 2021 FDA Publish Date: February 03, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Packaging error resulting in incorrect dosage listed Company Name: Apotex Corp Brand Name: Brand …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 4, 2021 - 19:46 GMT

Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication - Initial Safety Trial Results Find Increased Risk of Serious Heart-...

[Posted 02/04/2021] AUDIENCE: Patient, Health Professional, Pharmacy, Rheumatology, Gastroenterology, Cardiology, Oncology ISSUE: The FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 4, 2021 - 19:36 GMT

A-S Medication Solutions Issues Voluntary Nationwide Recall of Acetaminophen Extra Strength Tablets Contained in Health Essentials ...

Summary Company Announcement Date: April 02, 2021 FDA Publish Date: April 02, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Products contain an incomplete prescription drug label Company Name: A-S Medication Solutions, LLM …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 2, 2021 - 16:16 GMT

Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Due to Risk of Fractures

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 Products EMBLEM S-ICD Subcutaneous Electrode Model Number: 3501 Manufacturing Dates: March 2016 and …

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Published on January 30, 2021 - 22:37 GMT

Penumbra’s Recall of the JET 7 Reperfusion Catheter Due to Distal Tip Damage

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 Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology, also known as JET 7 Xtra Flex All …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 30, 2021 - 22:37 GMT

2021 Medical Device Recalls

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Published on January 29, 2021 - 15:50 GMT

Safety Recall for Deluxe Heat Therapy Massager

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