Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 181 of 548
FDA Devices Moderate May 19, 2021
REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provid…
ICU Medical, Inc.
FDA Devices Moderate May 19, 2021
REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s …
ICU Medical, Inc.
FDA Devices Critical May 19, 2021
Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
Infusion Pump Repair
FDA Devices Critical May 19, 2021
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
STEP-HAR MEDICAL LLC
FDA Devices Critical May 19, 2021
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide singl…
St. Jude Medical, Cardian Rhythm Management Division
FDA Devices Moderate May 19, 2021
REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usage: provides …
ICU Medical, Inc.
FDA Devices Moderate May 19, 2021
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 00801741027185 …
Bard Peripheral Vascular Inc
FDA Devices Moderate May 19, 2021
REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros ; w/ChemoLock; Syringe Tra…
ICU Medical, Inc.
FDA Devices Moderate May 19, 2021
ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enab…
Argo Medical Technologies Ltd
FDA Devices Critical May 19, 2021
Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
Medical Action Industries, Inc. 306
FDA Devices Critical May 19, 2021
Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
Medical Action Industries, Inc. 306
FDA Devices Moderate May 19, 2021
REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient admin…
ICU Medical, Inc.
FDA Devices Moderate May 19, 2021
NM/CT 860 Nuclear Medicine / CT Scanners
GE Healthcare, LLC
FDA Devices Moderate May 19, 2021
Regard Dressing Change Tray
ROi CPS LLC
FDA Devices Moderate May 19, 2021
REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administ…
ICU Medical, Inc.
FDA Devices Moderate May 19, 2021
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on t…
Meridian Bioscience Inc
FDA Devices Moderate May 19, 2021
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 00801741027192 …
Bard Peripheral Vascular Inc
FDA Devices Moderate May 19, 2021
REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: provides a…
ICU Medical, Inc.
FDA Devices Moderate May 19, 2021
REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros , Bag Hanger, Drop-In Red Cap…
ICU Medical, Inc.
FDA Devices Moderate May 19, 2021
REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular s…
ICU Medical, Inc.
FDA Devices Moderate May 19, 2021
Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
Atos Medical AB
FDA Devices Moderate May 19, 2021
REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUSSO, BCV, Y-Clave - Product Usage: provides access for the administrat…
ICU Medical, Inc.
FDA Devices Moderate May 19, 2021
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Randox Laboratories Ltd.
FDA Devices Moderate May 19, 2021
NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
Abbott Laboratories Inc. (St Jude Medical)
FDA Devices Moderate May 19, 2021
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
Haag-Streit USA Inc
FDA Devices Moderate May 19, 2021
REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the administration …
ICU Medical, Inc.
FDA Devices Moderate May 19, 2021
REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PORT, BCV, Spiros - Product Usage: provides access for the administration …
ICU Medical, Inc.
FDA Devices Moderate May 19, 2021
REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip Chamber, Clave", Spiros" w/Red Cap, Bag Hanger - Product Usage: provi…
ICU Medical, Inc.
FDA Devices Moderate May 19, 2021
REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros¿ Closed Male Luer, Purple Cap - Product Usage: provides a…
ICU Medical, Inc.
FDA Devices Critical May 19, 2021
Kit: Blood Culture. MAI Kit Part Number: 80315D
Medical Action Industries, Inc. 306
FDA Devices Moderate May 19, 2021
REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provid…
ICU Medical, Inc.
FDA Devices Moderate May 19, 2021
REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Product Usage: provides acces…
ICU Medical, Inc.
FDA Devices Moderate May 19, 2021
REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Product Usage: provides access for the administration of fluids from a …
ICU Medical, Inc.
FDA Devices Moderate May 19, 2021
REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros" - Product Usage: provides access for the administration of f…
ICU Medical, Inc.
FDA Devices Moderate May 12, 2021
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate May 12, 2021
DJO EMPOWR KNEE Femoral Sizer
Encore Medical, LP
FDA Devices Moderate May 12, 2021
Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with AdaptiveSti…
Medtronic Neuromodulation
FDA Devices Moderate May 12, 2021
Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube duri…
Oto Med Inc
FDA Devices Moderate May 12, 2021
CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide car…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate May 12, 2021
VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated …
Greiner Bio-One North America, Inc.
FDA Devices Moderate May 12, 2021
Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac …
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate May 12, 2021
CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara C…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate May 12, 2021
Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate May 12, 2021
LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the ves…
LeMaitre Vascular, Inc.
FDA Devices Moderate May 5, 2021
KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in o…
ConMed Corporation
FDA Devices Moderate May 5, 2021
Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, bu…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate May 5, 2021
Power Wheelchair
Merits Holdings Co. dba Merits Health Products, Inc.
FDA Devices Moderate May 5, 2021
Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of d…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate May 5, 2021
VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction fact…
Ortho-Clinical Diagnostics, INc.
FDA Devices Moderate May 5, 2021
UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sac…
Boston Scientific Corporation