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Channel: Medical Device Recalls since April 03, 2025
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3M Company/3m Espe Dental Products - 3M ESPE Unitek Primary Stainless Steel...

3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box). Product Usage: Stainless Steel Crowns are designed to...

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Zimmer, Inc. - Zimmer Periarticular Locking Plate System, Distal Medial...

ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT 11 HOLES 178 MM LENGTH STERILE RX ONLY Product Usage: Usage: The Periarticular Locking Plate System is...

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Medtronic Inc. Cardiac Rhythm Disease Management - Medtronic Custom Perfusion...

Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01R, TL5D02R, TL5D02R3, TL5D02R5, and TL6A65R7. Sterilized by...

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Medtronic Inc. Cardiac Rhythm Disease Management - Medtronic Custom Perfusion...

Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for...

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Medtronic Inc. Cardiac Rhythm Disease Management - Medtronic Custom Perfusion...

Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: This product is...

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GE Healthcare, LLC - GE Ultrasound ViewPoint 6 - Class 2 Recall

GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic...

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Roche Diagnostics Operations, Inc. - ACCUCHECK FastClix - Class 2 Recall

ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.

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Siemens Healthcare Diagnostics - ADVIA 120 - Class 2 Recall

ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.

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Ventana Medical Systems Inc - Benchmark & Discovery - Class 2 Recall

Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically...

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Becton Dickinson & Co. - PrepStain Tecan USI - Class 2 Recall

PrepStain Tecan US-I. For use in the screening and detection of cervical cancer.

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GE Healthcare, LLC - Dash 3000/4000/5000 Patient Monitor - Class 2 Recall

GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients.

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GE Healthcare, LLC - Solar 8000 and Transport Pro with Patient Data Module...

SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted...

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GE Healthcare, LLC - TRAM module - Class 2 Recall

GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal...

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Becton Dickinson & Co. - PrepStain Tecan USII - Class 2 Recall

PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.

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Becton Dickinson & Co. - PrepStain AG - Class 2 Recall

PrepStain AG. For use in the screening and detection of cervical cancer.

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Siemens Medical Solutions USA, Inc - Siemens Axiom Artis - Class 2 Recall

Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.

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DeRoyal Industries Inc - Insufflation Tubing Sets - Class 2 Recall

DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only 3) REF 28-0216 Tubing, Insuf w/.3 Micr Filter Rx Only 4)...

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Stryker Howmedica Osteonics Corp. - Stryker Orthopaedics - Class 2 Recall

Stryker Howmedica Osteonics Non-Sterile Instruments Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 The triathlon...

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Copan Italia - WASP (Walk Away Specimen Process) Instrument software - Class...

WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the...

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Stelkast Co - SC2316, Distal Femoral Augment with Screw - Class 2 Recall

SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous...

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