FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on August 17, 2023 - 16:37 GMT

Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for PCBA Failures Affecting the ...

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 14, 2023 - 20:40 GMT

Philips Respironics Recalls Trilogy Evo, Evo O2, EV300, and Evo Universal Ventilators After Finding Dust and Dirt in Air Path That ...

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Device Use Philips Respironics Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators provide …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 13, 2023 - 23:59 GMT

Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Unexpected Shutdowns

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Recalled Product: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 13, 2023 - 23:59 GMT

Do Not Use Tests Manufactured by Universal Meditech, Inc.: FDA Safety Communication

Date Issued: August 11, 2023 The U.S. Food and Drug Administration (FDA) is warning consumers and patients to not use the following tests manufactured by Universal Meditech, Inc. (UMI): One Step Pregnancy Test DiagnosUS One Step Ovulation Test …

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Published on August 12, 2023 - 11:54 GMT

Getinge Recalls CARDIOHELP Emergency Drive due to an Impaired or Inability to Turn the Drive

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: CARDIOHELP Emergency Drive Product Codes: See Recall Database Entry Model Numbers: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 9, 2023 - 18:40 GMT

Church & Dwight Initiates Voluntary Recall of One Specific Lot of TheraBreath Kids Strawberry Splash 16oz Sold Exclusively on ...

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 July 31, 2023 - 21:03 GMT

Baxter Healthcare Corporation Recalls SIGMA Spectrum Infusion Pumps with Master Drug Library and Spectrum IQ Infusion Systems with ...

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) and Spectrum IQ …

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Published on July 31, 2023 - 15:06 GMT

Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of TydemyTM (Drospirenone, Ethinyl Estradiol 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 …

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Published on July 31, 2023 - 13:58 GMT

Baxter Issues Urgent Medical Device Correction for Spectrum V8 and Spectrum IQ Infusion Pumps with Specific Software Versions

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 …

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Published on July 28, 2023 - 11:32 GMT

GE HealthCare Recalls TruSignal SpO2 Sensors for Issues That May Reduce Defibrillation Energy, Expose Patients to Unintended ...

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: TruSignal Adult Pediatric Sensor TruSignal AllFit Sensor TruSignal Sensitive …

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Published on July 27, 2023 - 13:06 GMT

Abiomed Recalls All Impella Left Sided Blood Pumps for Risk of Motor Damage After Contact with Transcatheter Aortic Valve ...

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Please be aware, this recall is a voluntary correction, not a product removal. Recalled Product Product Names and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 26, 2023 - 14:46 GMT

Abbott Recalls Amplatzer Steerable Delivery Sheath for Increased Risk of Air Embolism

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Amplatzer Steerable Delivery Sheath Product Model: ASDS-14F-075 Distribution Dates …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 19, 2023 - 15:09 GMT

Use Alternative Testing Method for the Quidel Cardiovascular Inc. Quidel Triage Cardiac Panel - Letter to Health Care Providers

July 19, 2023 The U.S. Food and Drug Administration (FDA) is recommending health care providers, laboratory personnel, and facilities stop using the Quidel Triage Cardiac Panel, manufactured by Quidel Cardiovascular Inc. (QuidelOrtho). On May 25, 2023, …

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Published on July 18, 2023 - 13:31 GMT

Medtronic Recalls Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) ...

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Cobalt XT, Cobalt, Crome ICDs and CRT-Ds Claria MRI, Amplia MRI, Compia MRI, Viva, …

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Published on July 17, 2023 - 15:29 GMT

Do Not Use RoyalVibe Health, CellQuicken, or Well-Being Reality Ultrasound Medical Devices: FDA Safety Communication

Date Issued: July 17, 2023 The U.S. Food and Drug Administration (FDA) is warning consumers not to use ultrasound medical devices manufactured and distributed by RoyalVibe Health, CellQuicken, or Well-Being Reality. The devices have not been reviewed by …

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Published on July 17, 2023 - 13:16 GMT

Quidel Cardiovascular Inc. Recalls Quidel Triage Cardiac Panels for Risk of False Negative Troponin Results that Could Cause ...

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Quidel Triage Cardiac Panel Quidel Triage Cardiac Panel, Troponin I Quidel Triage …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 13, 2023 - 18:10 GMT

NOxBOX Ltd. Recalls NOxBOXi Nitric Oxide System for Manifold Failure that May Cause Gas Leaks and Interrupt Therapy to Neonates

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: NOxBOXi Nitric Oxide Delivery System Product Serial Numbers: See Recall Database …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 13, 2023 - 18:10 GMT

Draeger Medical Recalls Oxylog 3000 Plus Emergency and Transport Ventilators for Risk of Unexpected Depleted Battery and ...

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Oxylog 3000 Plus Emergency and Transport Ventilator Part Numbers: 5704811 and …

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Published on July 12, 2023 - 17:56 GMT

Cardinal Health Issues Medical Device Recall for Nurse Assist Products Contained Within Kits/Trays

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 July 11, 2023 - 21:04 GMT