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Channel: Medical Device Recalls since April 03, 2025
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Biomet 3i, LLC - T3 Dental Implant - Class 2 Recall

Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)

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Carefusion 2200 Inc - AirLife - Class 2 Recall

1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017,...

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Medtronic Navigation, Inc. - STEALTHSTATION TREATMENT GUIDANCE PLATFORM -...

StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.

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Siemens Healthcare Diagnostics, Inc - ADVIA Centaur Calibrator A - Class 3...

ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3,...

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Terumo Cardiovascular Systems Corporation - Terumo Advanced Perfusion System...

Terumo¿ Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial...

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Terumo Cardiovascular Systems Corporation - Terumo Advanced Perfusion System...

Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for...

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Medtronic Inc. Cardiac Rhythm Disease Management - Affinity Pediatric...

Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. The Affinity Pediatric Arterial Filters are single-use, sterile, nonpyrogenic devices designed to...

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Edwards Lifesciences, LLC - Edwards EndoReturn Arterial Cannula, model ER21B...

Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector...

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Epocal - epoc BGEM Test Card - Class 2 Recall

epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.

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Arrow International Inc - Arrow TwoLumen CVC Kit with Blue Flex Tip Catheter...

Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.

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Terumo Cardiovascular Systems Corporation - Terumo Advanced Perfusion System...

Terumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion,...

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Edwards Lifesciences, LLC - Anastaflo Intravascular Shunt - Class 2 Recall

Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25 Anastaflo shunts are intended for use in preventing...

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Terumo Cardiovascular Systems Corporation - Terumo Advanced Perfusion System...

Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion,...

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Siemens Medical Solutions USA, Inc - Siemens syngo.plaza - Class 2 Recall

Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system

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Terumo Cardiovascular Systems Corporation - Terumo Advanced PErfusion System...

100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion,...

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Terumo Cardiovascular Systems Corporation - Terumo Advanced PErfusion System...

100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion,...

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Boston Scientific CRM Corp - ENERGEN DR ICD - Class 2 Recall

Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.

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Zimmer, Inc. - Moore Hip Prosthesis Long Fenestrated Stem - Class 2 Recall

Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement.

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Endogastric Solutions Inc - EndoGastric Solutions EsophyX2 Device - Class 2...

EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.

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Invacare Corporation - CHAMPION Medical Recliner, AC Powered with heat and...

CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery.

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