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Channel: Medical Device Recalls since April 03, 2025
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RAYSEARCH LABORATORIES AB - RayStation Therapy Treatment Planning System -...

RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment...

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Alphatec Spine, Inc. - Leucadia Autolok Polyaxial Pedicle Screw System -...

Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.

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Becton Dickinson & Co. - BBL DrySlide Oxidase kit - Class 2 Recall

BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria.

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Intuitive Surgical, Inc. - daVinci TORS Indication of Use - Class 2 Recall

Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including...

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Intuitive Surgical, Inc. - daVinci - Class 2 Recall

User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the...

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Intuitive Surgical, Inc. - EndoWrist MCS Tip Cover Accessory - Class 2 Recall

Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The...

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Becton Dickinson & Co. - BBL DrySlide PYR kit - Class 2 Recall

BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.

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Intuitive Surgical, Inc. - Flush Port - Class 2 Recall

Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.

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Intuitive Surgical, Inc. - da Vinci Si Surgeon Console - Class 2 Recall

da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.

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Beckman Coulter Inc. - AU2700 and AU5400 Clinical Chemistry Analyzers - Class...

AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.

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Intuitive Surgical, Inc. - Cannula 8MM Regular - Class 2 Recall

Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.

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Intuitive Surgical, Inc. - 8mm Maryland Bipolar Forceps - Class 2 Recall

8mm Maryland Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.

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Intuitive Surgical, Inc. - 8mm Fenestrated Bipolar Forceps - Class 2 Recall

8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.

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Intuitive Surgical, Inc. - 8mm Precise Bipolar Forceps - Class 2 Recall

8mm Precise Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.

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Nephron Pharmaceuticals Corp. - EZ Breathe Atomizer - Class 1 Recall

EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.

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Nephron Pharmaceuticals Corp. - Asthmanefrin Starter Kit - Class 1 Recall

Asthmanefrin Starter Kit contains ten (10) Asthmanefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liquid medications for respiratory usage.

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Nephron Pharmaceuticals Corp. - EZ Breathe Medication Cup - Class 1 Recall

EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage.

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Fisher & Paykel Healthcare, Ltd. - Fisher & Paykel Healthcare ICON...

Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. ICON Premo: ICONPBN,...

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TZ Medical Inc. - Medtronic/Physio Control Transparent Defibrillation...

adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency...

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Heart Sync, Inc - Heart Sync C100Physio Radiotransparent Defibrillation...

Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes Used in connection with a...

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