Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 185 of 548
FDA Devices Moderate Apr 7, 2021
EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF: CEDT200L, St…
EPIX THERAPEUTICS, INC
FDA Devices Moderate Mar 31, 2021
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016260 -…
Biosense Webster, Inc.
FDA Devices Moderate Mar 31, 2021
In-View Clear Leggings Sterile
Cardinal Health 200, LLC
FDA Devices Moderate Mar 31, 2021
VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems…
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Mar 31, 2021
Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monito…
Olympus Corporation of the Americas
FDA Devices Moderate Mar 31, 2021
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
In2Bones, SAS
FDA Devices Moderate Mar 31, 2021
The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycop…
Meridian Bioscience Inc
FDA Devices Moderate Mar 31, 2021
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubatio…
TELEFLEX MEDICAL INC
FDA Devices Moderate Mar 31, 2021
Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head …
Corin Ltd
FDA Devices Moderate Mar 31, 2021
Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (G…
Corin Ltd
FDA Devices Moderate Mar 31, 2021
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 -…
Biosense Webster, Inc.
FDA Devices Moderate Mar 31, 2021
Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Mar 31, 2021
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Baxter Healthcare Corporation
FDA Devices Moderate Mar 31, 2021
S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good…
Stryker Communications
FDA Devices Moderate Mar 31, 2021
VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, …
Biomerieux Inc
FDA Devices Moderate Mar 31, 2021
RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Mar 31, 2021
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Baxter Healthcare Corporation
FDA Devices Moderate Mar 31, 2021
Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient d…
Mizuho OSI
FDA Devices Moderate Mar 31, 2021
Operating Table System
Getinge Group Logistics America, LLC
FDA Devices Moderate Mar 31, 2021
Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultras…
Hitachi Medical Systems America Inc
FDA Devices Moderate Mar 31, 2021
Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuou…
Baxter Healthcare Corporation
FDA Devices Moderate Mar 31, 2021
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 …
Biosense Webster, Inc.
FDA Devices Moderate Mar 31, 2021
PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from …
TELEFLEX MEDICAL INC
CPSC Moderate Mar 25, 2021
Inyo Pool Products Recalls PureLine Pool Pump Motors Due to Fire Hazard; Sold Exclusively on inyopools.com (Recall Alert)
FDA Drug Low Mar 24, 2021
Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Dol…
Edge Pharma, LLC
FDA Devices Moderate Mar 24, 2021
VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITRO…
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Mar 24, 2021
CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tu…
Accuray Incorporated
FDA Devices Moderate Mar 24, 2021
JUDKINS PACK
Cardinal Health 200, LLC
FDA Devices Moderate Mar 24, 2021
Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited…
Epimed International, Inc.
FDA Devices Moderate Mar 24, 2021
RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a c…
Medline Industries Inc
FDA Devices Moderate Mar 24, 2021
McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of…
Cardinal Health 200, LLC
FDA Devices Moderate Mar 24, 2021
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pac…
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Mar 24, 2021
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
Sirtex Medical Limited
FDA Devices Moderate Mar 24, 2021
Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdr…
Cardinal Health 200, LLC
FDA Devices Critical Mar 24, 2021
Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) wi…
Medtronic Perfusion Systems
FDA Devices Critical Mar 24, 2021
Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosur…
Medtronic Perfusion Systems
FDA Devices Moderate Mar 24, 2021
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Siemens Healthcare Diagnostics, Inc
FDA Devices Moderate Mar 24, 2021
Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or …
CARESTREAM DENTAL, LLC
FDA Devices Critical Mar 24, 2021
Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance …
Medtronic Perfusion Systems
FDA Devices Critical Mar 24, 2021
Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a si…
Medtronic Perfusion Systems
FDA Devices Critical Mar 24, 2021
Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-u…
Medtronic Perfusion Systems
FDA Devices Critical Mar 24, 2021
Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface i…
Medtronic Perfusion Systems
CPSC Moderate Mar 24, 2021
Birdie Belay Devices Recalled Due to Risk of Injury; Made by Beal Sas
Beal Sas, of France
FDA Devices Moderate Mar 17, 2021
Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellit…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Mar 17, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348 - Product Usage: intended for anterior cervical fixation (C…
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Number: 66-363 - Product Usage: intended for anterior cervical fixation (C2…
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 38mm Material Number: 66-238 - Product Usage: intended for anterior cervical fixation (C2…
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021
Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to…
Insulet Corporation
FDA Devices Moderate Mar 17, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - Product Usage: intended for anterior cervical fixation (C…
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021
Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
Medtronic Vascular