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Channel: Medical Device Recalls since April 03, 2025
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Bio-Detek, Inc. - Zoll Medical Corp - Class 2 Recall

ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single...

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Motion Concepts - TRx Vertical Positioner - Class 2 Recall

TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.

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Genesis BPS, LLC. - Class 2 Recall

Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets,...

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Genesis BPS, LLC. - Class 2 Recall

Pedi-Pak Pedi-Syringe Filter 35 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets,...

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Genesis BPS, LLC. - Class 2 Recall

Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets,...

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Siemens Healthcare Diagnostics - ADVIA Centaur XP Immunoassay System - Class...

ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940,...

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Siemens Healthcare Diagnostics - ADVIA Centaur Immunoassay System - Class 2...

ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403,...

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Philips Medical Systems (Cleveland) Inc - Brilliance 64 and Ingenuity CT -...

The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different...

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Teleflex Medical - Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder...

Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or...

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Philips Medical Systems (Cleveland) Inc - Brilliance CT Big Bore - Class 2...

The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from the same...

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Siemens Healthcare Diagnostics, Inc. - Siemens CentraLink Data Management...

Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation...

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ORTHO-CLINICAL DIAGNOSTICS - VITROS Immunodiagnostic Products AntiHCV Reagent...

VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD --...

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Centurion Medical Products Corporation - Class 2 Recall

0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits.

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ICU Medical, Inc. - ICU STAT 2 - Class 1 Recall

98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal...

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ICU Medical, Inc. - ICU STAT 2 - Class 1 Recall

83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usage: IV Administration sets are intended for the infusion and...

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CareFusion 203, Inc. - The EnVe/ ReVel Ventilator - Class 1 Recall

CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is...

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ICU Medical, Inc. - ICU STAT 2 - Class 1 Recall

STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. Product Usage: IV Administration sets are intended for the...

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ICU Medical, Inc. - ICU STAT 2 - Class 1 Recall

STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. Product Usage: IV Administration sets are intended for the...

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Vidacare Corporation - EZIO - Class 2 Recall

EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455

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Philips Medical Systems (Cleveland) Inc - Brilliance CT System, Big Bore...

No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.

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