FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on June 12, 2025 - 01:23 GMT

Medtronic Announces Voluntary Recall of Select Newport™ HT70 and Newport™ HT70 Plus Ventilators and Certain Related Newport™ ...

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 8, 2025 - 13:28 GMT

Early Alert: WATCHMAN Access System Issue from Boston Scientific

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 8, 2025 - 13:27 GMT

Early Alert: Defibrillation Lead Issue from Boston Scientific

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 8, 2025 - 12:09 GMT

Early Alert: Electrophysiology Catheter Issue from Medline ReNewal

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 7, 2025 - 00:15 GMT

Church & Dwight Co., Inc. Issues Voluntary Nationwide Recall of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, 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 June 6, 2025 - 20:05 GMT

Infusion Pump Correction: Baxter Updates Instructions for Use for Novum IQ Large Volume Pump due to Potential for Underinfusion

This recall involves updating instructions for using devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 27, 2025 - 15:04 GMT

Risk of False Positive Lead Test Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare ...

Date Issued: April 24, 2025 The U.S. Food and Drug Administration (FDA) is alerting health care providers and laboratory staff of reports that falsely elevated (false positive) results have occurred when using ASP Global’s RAM Scientific SAFE-T-FILL Micro …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 23, 2025 - 18:05 GMT

Esophagogastric Tube Recall: BD Issues Correction for Esophagogastric Balloon Tamponade Tubes due to Challenges Removing Plastic ...

This recall involves updating the Instructions for using these devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 23, 2025 - 04:00 GMT

Cetirizine or Levocetirizine: Drug Safety Communication - FDA Warns About Risk of Severe Itching After Discontinuation of Long-...

AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Dermatology ISSUE: The FDA is warning that patients stopping the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) after long-term use may experience rare but severe …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 22, 2025 - 21:49 GMT

UMARY- USA.COM Issues Voluntary Nationwide Recall of UNAVY ÁCIDO HIALURÓNICO Caplets and UMOVY ÁCIDO HIALURÓNICO Caplets Due to ...

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 13, 2025 - 06:16 GMT

FDA and CDC Recommend Pause in Use of Ixchiq (Chikungunya Vaccine, Live) in Individuals 60 Years of Age and Older While ...

[Posted 05/12/2025] AUDIENCE: Patient, Health Care Professional, Pharmacy ISSUE: The FDA and the CDC are recommending a pause in the use of Ixchiq (Chikungunya Vaccine, Live) in individuals 60 years of age and older while the Agencies investigate …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 7, 2025 - 04:00 GMT

FDA Advises Consumers, Tattoo Artists, and Retailers to Avoid Using or Selling Certain Sacred Tattoo Ink Products Contaminated ...

[Posted 05/07/2025] Audience Consumers who are considering a new tattoo Tattoo artists Retailers of tattoo inks Product FDA laboratory analysis has found that the following tattoo inks are contaminated with pathogenic microorganisms: Sacred Tattoo Ink, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 6, 2025 - 18:37 GMT

EnShiShiXiangNiShangMaoYouXianGongSi Issues Voluntary Nationwide Recall of ENDURANCE BOOST WITH HORNY GOAT WEED Capsules Due To ...

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 6, 2025 - 12:43 GMT

Infusion Pump Recall: Infusion Pump Intermittent Connection Issue from Smiths Medical

This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 6, 2025 - 12:43 GMT

Infusion Pump Recall: Infusion Pump Thermal Damage Issue from Smiths Medical

This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 6, 2025 - 12:43 GMT

Infusion Pump Recall: False Alarm Issue with Infusion Pump from Smiths Medical

This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 6, 2025 - 10:07 GMT

Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pump due to Potential for Underinfusion

This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 6, 2025 - 08:49 GMT

Flexible Tracheostomy Tube Recall: Medtronic Removes Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner ...

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Names: Shiley …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 6, 2025 - 08:49 GMT

Anesthesia Breathing Circuit Kit Correction: Draeger, Inc. Updates Use Instructions for VentStar Flex and Anesthesia Circuit Kits ...

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Part No. Product Name …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 24, 2025 - 18:50 GMT

Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power Loss

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Names: HeartMate …

Distribution channels: Healthcare & Pharmaceuticals Industry