FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on July 10, 2025 - 10:36 GMT

Closed Suction Catheter Recall: Avanos Medical, Inc. Removes Ballard Closed Suction Systems Due to Risk of Non-Sterility

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 July 9, 2025 - 23:04 GMT

Broselow Pediatric Emergency Rainbow Tape Recall: AirLife Removes Certain Broselow Pediatric Emergency Rainbow Tapes 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 What to Do On May 15, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 9, 2025 - 23:04 GMT

Infant Breathing System Recall: AirLife/Vyaire Removes Infant Heated Wire Circuits Due to Risk for Inadvertent Adapter ...

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 Image A: Adaptors …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 8, 2025 - 15:51 GMT

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live): FDA Safety Communication

FDA Removes Recommended Pause in Use and Approves Required Updated Labeling AUDIENCE: Patient, Health Care Professional, Pharmacy, Cardiology, Neurology, Internal Medicine, Family Practice, Travel Clinics ISSUE: On May 9, 2025, FDA issued a safety …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 27, 2025 - 21:55 GMT

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging

Summary Company Announcement Date: June 27, 2025 FDA Publish Date: June 27, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Penicillin G Potassium Injection Vial Company Name: Sandoz Inc. Brand Name: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 26, 2025 - 13:18 GMT

mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and ...

AUDIENCE: Pediatrics, Pharmacy, Family Practice, Internal Medicine, Cardiology ISSUE: FDA has required and approved updates to the Prescribing Information for Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer Inc. and Spikevax (COVID-19 Vaccine, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 25, 2025 - 18:16 GMT

Angiographic Catheter Recall: Cook Removes Beacon Tip Angiographic Catheters due to Tip Separation

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 What to Do On May 15, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 24, 2025 - 16:15 GMT

Early Alert: Esophageal pH Monitoring Capsule Issue from Medtronic

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 24, 2025 - 16:15 GMT

Import Alerts for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care Providers

June 24, 2025 The U.S. Food and Drug Administration (FDA) is alerting health care providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries. Despite extensive and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 23, 2025 - 19:33 GMT

Resuscitation System Recall: ZOLL Circulation, Inc. Recalls AutoPulse NXT Resuscitation System Due to a Failure Code That May Stop ...

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 Name: AutoPulse …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 23, 2025 - 18:53 GMT

Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Procedure Kits Containing Medtronic Aortic ...

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 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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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