FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on January 30, 2025 - 17:31 GMT

Glucose and Glucose/Ketone Meter Correction: Nova Biomedical Corporation Issues Software Correction for StatStrip Glucose and ...

This recall involves correcting 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 without …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 24, 2025 - 20:29 GMT

Provepharm Inc. Issues Voluntary Nationwide Recall of One Lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/ mL (Pharmacy ...

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 January 22, 2025 - 21:44 GMT

Copaxone, Glatopa (glatiramer acetate): Drug Safety Communication - FDA Adds Boxed Warning About a Rare but Serious Allergic ...

[Posted 01/22/2025] AUDIENCE: Patient, Health Professional, Pharmacy, Neurology ISSUE: The FDA is warning about the risk of a rare but serious allergic reaction with the medicine glatiramer acetate (Copaxone, Glatopa), which is used to treat patients with …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 17, 2025 - 20:43 GMT

Max Mobility / Permobil Issues Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User

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 January 16, 2025 - 21:17 GMT

Early Alert: Infusion Pump Software Issue from Fresenius Kabi USA

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 January 16, 2025 - 16:35 GMT

Update: Evaluation of Airborne Chemicals from Neonatal Incubators - Letter to Health Care Providers

January 16, 2025 The U.S. Food and Drug Administration (FDA) is providing an update on its evaluation of the potential for exposure to airborne chemicals that may be released from neonatal incubators. Based on the FDA's review of the totality of the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 15, 2025 - 16:36 GMT

Endoscopic Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular Update Use Instructions for VasoView ...

The devices described in this recall are included in the related Letter to Health Care Providers. See the Letter to Health Care Providers for the most current information on these devices. This recall involves updating instructions for using devices, and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 13, 2025 - 16:41 GMT

Outpatient Telemetry Correction: Philips Issues Correction for Monitoring Service Application used with Mobile Cardiac Outpatient ...

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 January 12, 2025 - 12:52 GMT

Recall Alert: Glycar SA Removes Pericardial Patch

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 The FDA is aware that …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 7, 2025 - 21:33 GMT

FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety ...

[Posted 1/7/2025] AUDIENCE: Patient, Health Care Professional, Pharmacy, Immunology, Pulmonology ISSUE: FDA has required and approved safety labeling changes to the Prescribing Information for Abrysvo (Respiratory Syncytial Virus Vaccine) manufactured by …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 7, 2025 - 15:45 GMT

Early Alert: Infusion Pump Software Issue from Baxter

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 issue. The FDA will keep the public informed and update this web page as significant new information …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 7, 2025 - 15:15 GMT

Early Alert: Blood Pump Controller Issue from Abiomed

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 issue. The FDA will keep the public informed and update this web page as significant new information …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 31, 2024 - 16:20 GMT

Early Alert: Solution Set Issue from Baxter Healthcare Corporation

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 …

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Published on December 30, 2024 - 18:48 GMT

Early Alert: Fluid Delivery Set Issue from Medline

99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000128741 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000134505 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000133893 10193489069587 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 30, 2024 - 18:05 GMT

Early Alert: Extracorporeal Blood Circuit Issue from Nuwellis

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 December 25, 2024 - 01:16 GMT

Astellas Pharma US, Inc. Issues Voluntary Nationwide Recall of One Lot of PROGRAF® 0.5mg (Tacrolimus) and One Lot of ASTAGRAF XL® ...

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 December 23, 2024 - 21:15 GMT

Early Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus

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 December 23, 2024 - 19:30 GMT

Alcon Laboratories Issues Voluntary Nationwide Recall of One (1) Lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-...

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 December 20, 2024 - 23:09 GMT

Endo USA, Inc. Issues Voluntary, Nationwide Recall of Adrenalin® Chloride Solution (EPINEPHrine Nasal Solution, USP) Due to the ...

Summary Company Announcement Date: December 20, 2024 FDA Publish Date: December 20, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Product is an unapproved drug. Company Name: Endo, Inc. Brand Name: Brand Name(s) Product …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 20, 2024 - 15:47 GMT

Early Alert: Nephroscope Sheath Issue from Trokamed GmbH

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