FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on November 19, 2024 - 18:22 GMT

Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength ...

Summary Company Announcement Date: November 18, 2024 FDA Publish Date: November 19, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeled with the incorrect strength on the carton Company Name: Endo, Inc. Brand Name: Brand …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 19, 2024 - 15:20 GMT

Battery Pack Correction: Smiths Medical Updates Use Instructions for CADD-Solis Li-ion Rechargeable Battery Packs Due to Risk That ...

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 November 15, 2024 - 15:41 GMT

Endoscopic Vessel Harvesting System Recall: Getinge and Maquet Cardiovascular Remove VasoView HemoPro 1 and 1.5 Endoscopic Vessel

The devices described in this recall are included in the related Letter to Health Care Providers. On November 15, 2024, the FDA added EVH devices (product code GEI) to the medical device shortage list. See the related Letter to Health Care Providers for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 15, 2024 - 15:41 GMT

Safety and Availability Concerns with VasoView HemoPro Endoscopic Vessel Harvesting Systems - Letter to Health Care Providers

November 15, 2024 The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities about safety concerns with the use of Getinge/Maquet VasoView HemoPro Endoscopic Vessel Harvesting (EVH) Systems, and a supply concern for EVH …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 12, 2024 - 10:02 GMT

Early Alert: Infusion Pump 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 October 31, 2024 - 18:53 GMT

Incubator/Warmer Correction: GE Healthcare Updates Use Instructions for Giraffe OmniBed and Giraffe Omnibed CareStation due to ...

2082844-001-526493, 1TABX6226911180201 (TABX62269) 2082844-001-526493, 1TABX6215911180122 (TABX62159) 2082844-001-526493, 1TABX6219811180129 (TABX62198) 2082844-001-526493, 1TABX6227011180201 (TABX62270) 2082844-001-526493, 1TABX6229111180202 (TABX62291 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 29, 2024 - 17:36 GMT

Air Compressor Device Correction: GE HealthCare Provides Updates to EVair Compressors Due to Final Formaldehyde Testing Results

This recall involves updating recall 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 …

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Published on October 29, 2024 - 17:36 GMT

Update: Use of GE HealthCare EVair and EVair 03 Compressors - Letter to Health Care Providers

October 29, 2024 The U.S. Food and Drug Administration (FDA) is issuing this update to inform the health care community of a change in recommendations for the GE HealthCare EVair Compressor. Previously, on December 29, 2023, GE HealthCare issued an Urgent …

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Published on October 25, 2024 - 18:09 GMT

Assistive Arm Correction: Kinova Issues Correction for Jaco Assistive Robotic Arm due to Fire Hazard and Burn Risk

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 October 25, 2024 - 17:12 GMT

Update: Do Not Use BioZorb Marker Implantable Radiographic Marker Devices: FDA Safety Communication

Español 简体中文 (Simplified Chinese) Tagalog Date Issued: October 25, 2024 The U.S. Food and Drug Administration (FDA) is alerting consumers, health care providers and health care facilities not to use BioZorb Markers and BioZorb LP Markers (hereafter …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 25, 2024 - 16:11 GMT

Tracheostomy Tube Recall: Smiths Medical Removes BLUselect, BLUgriggs, and BLUperc Tracheostomy Tube Kits due to Potential ...

BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX 101/800/060CZ 3895097 3925835 4025600 4106716 4230149 4252500 4382002 BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX 101/800/070CZ 3895101 3925960 3933088 4010050 4022790 4034826 4037975 4133612 4152440 4156971 4217804 4238237 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 19, 2024 - 01:35 GMT

Voluntary Recall Notifying Medtronic Insulin Pump Users of Potential Risks of Shortened Pump Battery Life

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 October 18, 2024 - 19:17 GMT

Vascular Embolization Device Correction: Boston Scientific Updates Use Instructions for Obsidio Conformable Embolic for Increased ...

This recall involves updating 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 October 16, 2024 - 04:00 GMT

UPDATE: Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication

Español 简体中文 (Simplified Chinese) Tagalog Update: October 16, 2024 The FDA has classified Cue Health’s recall of their two COVID-19 tests as Class II. FDA has also revoked the Emergency Use Authorization (EUA) for Cue Health’s two COVID-19 tests. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 16, 2024 - 04:00 GMT

C&A Naturistics Issues Voluntary Nationwide Recall of AK Forte Tablets con Ortiga y Omega 3 Due to the Presence of Undeclared Drug ...

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 October 16, 2024 - 04:00 GMT

Staska Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Ascorbic Acid Solution for Injection (Preservative Free, Non-...

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 October 11, 2024 - 17:08 GMT

Infusion Pump Recall: Zyno Medical Removes Z-800, Z-800F, Z-800W, and Z800WF Infusion Pumps due to an Air-in-Line Software Defect ...

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 Pump Model Unique …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 30, 2024 - 19:02 GMT

Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume ...

Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement This recall involves correcting devices, and does not involve removing them from where they are used or sold …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 24, 2024 - 14:00 GMT

Compounding Device Inlet Correction: Baxter Healthcare Corporation Updates Use Instructions for Exactamix Automated Compounding ...

Automated Compounding Device Inlets used with Exactamix Compounding Devices may contain particulate matter that poses a risk to patients.

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 23, 2024 - 16:32 GMT

Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a ...

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