Browse recalls
Issuing authority: US FDA — Medical Devices
- 2023-07-25 · US FDA — Medical DevicesClass II
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the qu - 2023-07-24 · US FDA — Medical DevicesClass II
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail - 2023-07-19 · US FDA — Medical DevicesClass II
Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C - 2023-07-13 · US FDA — Medical DevicesClass II
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314 - 2023-07-12 · US FDA — Medical DevicesClass II
nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT; radiation monitoring dosi - 2023-07-12 · US FDA — Medical DevicesClass II
nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO; radiation monitoring do - 2023-07-12 · US FDA — Medical DevicesClass II
Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) 18150-KIT; radiation mon - 2023-07-12 · US FDA — Medical DevicesClass II
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEO - 2023-07-12 · US FDA — Medical DevicesClass II
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sens - 2023-07-12 · US FDA — Medical DevicesClass II
QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the microSTAR reade - 2023-07-12 · US FDA — Medical DevicesClass II
nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR re - 2023-07-12 · US FDA — Medical DevicesClass II
Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers - 2023-07-12 · US FDA — Medical DevicesClass II
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-KIT; c) 18120-SET; radiation monitoring d - 2023-07-12 · US FDA — Medical DevicesClass II
nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring dosimeter used with the microSTA - 2023-07-12 · US FDA — Medical DevicesClass II
nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosimeter used with the microSTAR r - 2023-07-12 · US FDA — Medical DevicesClass II
nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring dosimeter used with the microSTAR - 2023-07-12 · US FDA — Medical DevicesClass II
QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNAN005); b) 04225-KIT; c) 04225-SET; radi - 2023-07-12 · US FDA — Medical DevicesClass II
nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3MO; d) 03053-OTO; e) 03053-SMO; radiatio - 2023-07-12 · US FDA — Medical DevicesClass II
nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR re - 2023-07-12 · US FDA — Medical DevicesClass II
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET; radiation monitoring dosimete - 2023-07-12 · US FDA — Medical DevicesClass II
nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b) 03056-1MO; c) 03056-3MO; d) 03056-KIT; - 2023-07-12 · US FDA — Medical DevicesClass II
QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used with the microSTAR reade - 2023-07-12 · US FDA — Medical DevicesClass II
NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers - 2023-07-12 · US FDA — Medical DevicesClass II
Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number VKITCON001); b) 18155-KIT; radiation mon - 2023-07-12 · US FDA — Medical DevicesClass II
Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring dosimeter used with the microSTA - 2023-07-12 · US FDA — Medical DevicesClass II
nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO; radiation monitoring dosi - 2023-07-12 · US FDA — Medical DevicesClass II
Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation monitoring dosimeter used with the microSTA - 2023-07-12 · US FDA — Medical DevicesClass II
QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) 18135-SET; radiation monitoring dosimete - 2023-07-12 · US FDA — Medical DevicesClass II
nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO; d) 03061-SMO; radiation monitoring dosi - 2023-07-12 · US FDA — Medical DevicesClass II
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System - 2023-07-12 · US FDA — Medical DevicesClass II
nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR re - 2023-07-12 · US FDA — Medical DevicesClass II
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c) 18121-SET; radiation monitoring do - 2023-07-12 · US FDA — Medical DevicesClass II
nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO; d) 03062-SMO; radiation monitoring dosi - 2023-07-10 · US FDA — Medical DevicesClass II
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl tran - 2023-07-10 · US FDA — Medical DevicesClass II
Atellica CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human ser - 2023-07-10 · US FDA — Medical DevicesClass II
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human se - 2023-07-10 · US FDA — Medical DevicesClass II
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human seru - 2023-07-07 · US FDA — Medical DevicesClass II
LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, T - 2023-06-28 · US FDA — Medical DevicesClass I
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603 - 2023-06-28 · US FDA — Medical DevicesClass I
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629 - 2023-06-28 · US FDA — Medical DevicesClass I
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637 - 2023-06-28 · US FDA — Medical DevicesClass II
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and c - 2023-06-28 · US FDA — Medical DevicesClass II
ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest - 2023-06-28 · US FDA — Medical DevicesClass II
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and ch - 2023-06-28 · US FDA — Medical DevicesClass I
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611 - 2023-06-28 · US FDA — Medical DevicesClass I
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002H - 2023-06-23 · US FDA — Medical DevicesClass II
LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta - 2023-06-23 · US FDA — Medical DevicesClass II
SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aor - 2023-06-23 · US FDA — Medical DevicesClass II
YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. - 2023-06-23 · US FDA — Medical DevicesClass II
UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift system. Instrument for insertion of a cysto - 2023-06-23 · US FDA — Medical DevicesClass II
SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in th - 2023-06-23 · US FDA — Medical DevicesClass II
TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta - 2023-06-23 · US FDA — Medical DevicesClass II
ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and - 2023-06-22 · US FDA — Medical DevicesClass II
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medica - 2023-06-20 · US FDA — Medical DevicesClass II
Ringed DxI Reaction Vessels (RVs) - 2023-06-19 · US FDA — Medical DevicesClass II
ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Mate - 2023-06-19 · US FDA — Medical DevicesClass II
ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. - 2023-06-15 · US FDA — Medical DevicesClass I
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 - 2023-06-14 · US FDA — Medical DevicesClass II
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affecte - 2023-06-14 · US FDA — Medical DevicesClass I
Impella LD intravascular micro axial blood pump, Product Number 005082 - 2023-06-14 · US FDA — Medical DevicesClass I
Impella 5.0 intravascular micro axial blood pump, Product Number 005062 - 2023-06-14 · US FDA — Medical DevicesClass I
Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080 - 2023-06-13 · US FDA — Medical DevicesClass II
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena - 2023-06-12 · US FDA — Medical DevicesClass II
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Eliti - 2023-06-12 · US FDA — Medical DevicesClass II
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700) - 2023-06-08 · US FDA — Medical DevicesClass II
HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatme - 2023-06-08 · US FDA — Medical DevicesClass II
BD Synapsys Informatics Solution, Catalog Number 444150 - 2023-06-07 · US FDA — Medical DevicesClass II
BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is perf - 2023-06-06 · US FDA — Medical DevicesClass II
Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant ki - 2023-06-06 · US FDA — Medical DevicesClass I
GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 20828 - 2023-06-06 · US FDA — Medical DevicesClass II
OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, prim - 2023-06-06 · US FDA — Medical DevicesClass II
Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation - 2023-06-06 · US FDA — Medical DevicesClass II
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00 - 2023-06-06 · US FDA — Medical DevicesClass II
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant - 2023-06-05 · US FDA — Medical DevicesClass I
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0 - 2023-06-05 · US FDA — Medical DevicesClass I
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85 - 2023-06-05 · US FDA — Medical DevicesClass II
Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive - 2023-06-05 · US FDA — Medical DevicesClass II
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 - 2023-06-02 · US FDA — Medical DevicesClass II
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-US - 2023-05-30 · US FDA — Medical DevicesClass II
VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF) - 2023-05-30 · US FDA — Medical DevicesClass II
Alinity ci-series System Control Module, REF: 03R70-01 - 2023-05-26 · US FDA — Medical DevicesClass II
Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display m - 2023-05-26 · US FDA — Medical DevicesClass II
Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexibl - 2023-05-26 · US FDA — Medical DevicesClass II
Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexib - 2023-05-25 · US FDA — Medical DevicesClass II
Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy fr - 2023-05-25 · US FDA — Medical DevicesClass II
Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy f - 2023-05-25 · US FDA — Medical DevicesClass II
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleare - 2023-05-25 · US FDA — Medical DevicesClass II
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urolo - 2023-05-24 · US FDA — Medical DevicesClass II
NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and - 2023-05-22 · US FDA — Medical DevicesClass II
DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10 - 2023-05-22 · US FDA — Medical DevicesClass II
PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS - 2023-05-22 · US FDA — Medical DevicesClass II
PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10 - 2023-05-22 · US FDA — Medical DevicesClass II
DiagnosUS Pregnancy Test Midstream REF 100-17 - 2023-05-22 · US FDA — Medical DevicesClass II
PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE - 2023-05-22 · US FDA — Medical DevicesClass II
Lem Fertility hCG Pregnancy Urine Test REF 100-12 - 2023-05-22 · US FDA — Medical DevicesClass II
DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13 - 2023-05-22 · US FDA — Medical DevicesClass II
OMTMO One Step Ovulation (LH) Test Strips REF 200-07 - 2023-05-22 · US FDA — Medical DevicesClass II
One Step Pregnancy Test REF 100-01 - 2023-05-22 · US FDA — Medical DevicesClass II
HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10 - 2023-05-22 · US FDA — Medical DevicesClass II
PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips