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Channel: Medical Device Recalls since April 03, 2025
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SpineFrontier, Inc. - PedFuse Reset Screw Inserters - Class 2 Recall

PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw...

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SpineFrontier, Inc. - PedFuse Reset Screw Inserters - Class 2 Recall

PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw...

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SpineFrontier, Inc. - PedFuse Reset Screw Inserters - Class 2 Recall

PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw...

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Abbott Vascular, Inc. - HT Connect Peripheral Guide Wire - Class 2 Recall

HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT...

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Mckesson Information Solutions LLC - McKesson Radiology - Class 2 Recall

McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).

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Varian Medical Systems, Inc. - Eclipse Treatment Planning System - Class 2...

Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo...

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Integra LifeSciences Corp. d.b.a. Integra Pain Management - Integra Cranial...

Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra ¿ Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is...

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B. Braun Medical, Inc. - B. Braun Introcan Safety IV Catheter - Class 2 Recall

B. Braun Introcan Safety IV Catheter Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids, drugs,...

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CareFusion 303, Inc. - Alaris PC unit model 8000 and 8015 - Class 1 Recall

Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply...

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C.L.R. Medicals International, Inc. - Viscocel and Viscocel Plus - Class 1...

Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain...

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Siemens Healthcare Diagnostics - IMMULITE /IMMULITE 1000 Folic Acid - Class 2...

IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000...

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Siemens Healthcare Diagnostics, Inc. - Siemens Dimension(R) Chemistry Wash...

Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module

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Data Innovations, Inc. - Instrument Manager - Class 2 Recall

Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004,...

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Philips Medical Systems, Inc. - Philips Healthcare - Class 2 Recall

Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use...

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Ziehm Imaging Inc - Ziehm Imaging GmbH - Class 2 Recall

Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

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Ziehm Imaging Inc - Ziehm Imaging GmbH - Class 2 Recall

Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

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Ziehm Imaging Inc - Ziehm Imaging GmbH - Class 2 Recall

Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

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Ziehm Imaging Inc - Ziehm Imaging GmbH - Class 2 Recall

Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

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Ziehm Imaging Inc - Ziehm Imaging GmbH - Class 2 Recall

Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

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Ziehm Imaging Inc - Ziehm Imaging GmbH - Class 2 Recall

Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

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