FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on June 23, 2025 - 18:53 GMT

Anesthesia Delivery Systems Recall: GE HealthCare Issues Correction for Certain Carestations due to Risk of Ineffective ...

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 …

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Published on June 20, 2025 - 14:48 GMT

Transderm Scōp (Scopolamine Transdermal System): Drug Safety Communication - FDA Adds Warning About Serious Risk of Heat-Related ...

The patch can increase body temperature and cause heat-related complications, resulting in hospitalization or even death in some cases AUDIENCE: Patient, Health Care Professional, Neurology ISSUE: The FDA is warning that the antinausea patch Transderm Scōp …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 17, 2025 - 23:49 GMT

Convenience Kit Recall: Medline Industries, LP, Removes Medline Neonatal and Pediatric Kits containing Smiths Medical ORAL/NASAL ...

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 Products Product Name Product …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 17, 2025 - 23:49 GMT

Blood Products Administration Set Recall: Fresenius Kabi Removes Large Volume Pump Blood Products Administration Sets due to ...

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 Description Part …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 17, 2025 - 23:49 GMT

Aspiration Catheter Recall: Q’Apel Medical, Inc. Removes Hippo 072 Aspiration System and Cheetah Delivery Tool After FDA Warning ...

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 Products Product Names: 072 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 16, 2025 - 19:06 GMT

Infusion Pump Recall: Zyno Medical Removes Certain Z-800 Series Infusion Pumps due to Software Issue

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 Affected Serial Numbers …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 13, 2025 - 18:26 GMT

Intra-Operative Positioning System Guidewire Recall: Centerline Biomedical Removes Certain IOPS Guidewires due to Delamination

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 Device Name Model …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 13, 2025 - 13:22 GMT

Liquid Bicarbonate Concentrate Recall: Nipro Removes MedicaLyte Liquid Bicarbonate Concentrate due to Contamination

This recall involves removing 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 MedicaLyte Liquid Bicarbonate …

Distribution channels: Healthcare & Pharmaceuticals Industry

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