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Channel: Medical Device Recalls since April 03, 2025
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Summit Medical, Inc. - Summit Medical, BL2006, Myringotomy Lance (Juvenile)...

Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN 55121 Use to make an incision in the tympanic membrane.

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QIAGEN Gaithersburg, Inc. - Qiagen artus CMV RG PCR ASR (Analyte Specific...

QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using...

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QIAGEN Gaithersburg, Inc. - Qiagen artus CMV RG PCR ASR - Class 2 Recall

QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house...

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GE Healthcare, LLC - GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova...

GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and...

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Edwards Lifesciences, LLC - Proplege Coronary Sinus Catheter - Class 2 Recall

Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate...

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Heartware Inc - HVAD Pump Implant Kit - Class 2 Recall

REF 1103***HVAD Pump Implant Kit. Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.

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Varian Medical Systems, Inc. - Segmented Cylinder Applicator Set - Class 2...

Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.

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Iris Diagnostics - Iris Diagnostics Division iQ Control/Focus Set - Class 2...

Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.

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Varian Medical Systems, Inc. Oncology Systems - Varian High Energy Clinacs -...

Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27,H29, HCX, Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic...

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Medtox Diagnostics Inc - PROFILEV MEDTOXScan Drugs of Abuse Test System -...

PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,

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Becton Dickinson & Co. - BBL CDC Anaerobe 5 Sheep Blood Agar. - Class 2...

BBL(tm) CDC Anaerobe 5% Sheep Blood Agar. Used for culturing microorganisms.

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Becton Dickinson & Co. - BBL Trypticase Soy Agar with 5 Sheep Blood and...

BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for culturing microorganisms.

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Becton Dickinson & Co. - BBL Trypticase Soy Agar with 5 Sheep Blood -...

BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing microorganisms.

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Hologic, Inc. - Fluoroscan Mini Carm InSight2, software versions 3.x, 4.0,...

Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of...

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Hologic, Inc. - Fluoroscan Mini Carm InSight, software versions 1.x, 2.x, 3.x...

Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient,...

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Johnson & Johnson Vision Care, Inc. - 1DAy ACUVUE MOIST contact lens -...

1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. The Vistakon (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically), with UV Blocker...

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Johnson & Johnson Vision Care, Inc. - ACUVUE ADVANCE Brand Contact Lens -...

ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. The Vistakon (galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia...

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Linvatec Corp. dba ConMed Linvatec - HD Still Capture - Class 2 Recall

Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures.

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Philips Medical Systems (Cleveland) Inc - Brilliance CT - Class 2 Recall

Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, System Code: 728255; MX8000 IDT 16, System Code: 728120 & MX8000...

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Boston Scientific CRM Corp - LATITUDE Patient Management System - Class 2 Recall

LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and...

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