Browse recalls
Issuing authority: US FDA — Medical Devices
- 2024-09-05 · US FDA — Medical DevicesClass II
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive dis - 2024-09-05 · US FDA — Medical DevicesClass II
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an int - 2024-09-05 · US FDA — Medical DevicesClass II
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interacti - 2024-09-05 · US FDA — Medical DevicesClass II
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes a - 2024-09-05 · US FDA — Medical DevicesClass II
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an - 2024-09-05 · US FDA — Medical DevicesClass II
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; the system utilizes an - 2024-09-05 · US FDA — Medical DevicesClass II
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an - 2024-09-04 · US FDA — Medical DevicesClass II
Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 149 - 2024-09-04 · US FDA — Medical DevicesClass II
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedur - 2024-09-04 · US FDA — Medical DevicesClass II
Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples - 2024-09-04 · US FDA — Medical DevicesClass II
Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, - 2024-09-04 · US FDA — Medical DevicesClass II
Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 1 - 2024-09-04 · US FDA — Medical DevicesClass II
Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sect - 2024-09-04 · US FDA — Medical DevicesClass II
Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 149 - 2024-09-03 · US FDA — Medical DevicesClass I
GE Heathcare Giraffe OmniBed; neo natal incubator - 2024-09-03 · US FDA — Medical DevicesClass III
Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective feature - 2024-09-03 · US FDA — Medical DevicesClass II
Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of t - 2024-09-03 · US FDA — Medical DevicesClass II
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectr - 2024-09-03 · US FDA — Medical DevicesClass II
Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra o - 2024-09-03 · US FDA — Medical DevicesClass II
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or sp - 2024-09-03 · US FDA — Medical DevicesClass II
SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic im - 2024-09-03 · US FDA — Medical DevicesClass II
Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra - 2024-09-03 · US FDA — Medical DevicesClass II
SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images an - 2024-09-03 · US FDA — Medical DevicesClass II
Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectr - 2024-09-03 · US FDA — Medical DevicesClass II
Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of th - 2024-09-03 · US FDA — Medical DevicesClass II
SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images a - 2024-09-01 · US FDA — Medical DevicesClass II
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N - 2024-08-29 · US FDA — Medical DevicesClass II
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b - 2024-08-29 · US FDA — Medical DevicesClass II
Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic - 2024-08-28 · US FDA — Medical DevicesClass II
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket - 2024-08-26 · US FDA — Medical DevicesClass II
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: - 2024-08-26 · US FDA — Medical DevicesClass II
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: - 2024-08-23 · US FDA — Medical DevicesClass II
Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum - 2024-08-22 · US FDA — Medical DevicesClass II
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spin - 2024-08-22 · US FDA — Medical DevicesClass II
Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is emp - 2024-08-21 · US FDA — Medical DevicesClass II
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40 - 2024-08-21 · US FDA — Medical DevicesClass II
Horizon Cardiology Hemo. Version 12.2. - 2024-08-20 · US FDA — Medical DevicesClass I
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device - 2024-08-20 · US FDA — Medical DevicesClass I
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device - 2024-08-20 · US FDA — Medical DevicesClass I
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device - 2024-08-15 · US FDA — Medical DevicesClass II
SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemod - 2024-08-15 · US FDA — Medical DevicesClass II
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodi - 2024-08-15 · US FDA — Medical DevicesClass II
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodi - 2024-08-15 · US FDA — Medical DevicesClass II
STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during hae - 2024-08-15 · US FDA — Medical DevicesClass II
STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model - 2024-08-15 · US FDA — Medical DevicesClass II
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2. - 2024-08-15 · US FDA — Medical DevicesClass II
ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultraso - 2024-08-15 · US FDA — Medical DevicesClass II
Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human - 2024-08-15 · US FDA — Medical DevicesClass II
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software - 2024-08-13 · US FDA — Medical DevicesClass II
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and v - 2024-08-12 · US FDA — Medical DevicesClass II
Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video - 2024-08-09 · US FDA — Medical DevicesClass II
GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; - 2024-08-08 · US FDA — Medical DevicesClass II
Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-ce - 2024-08-08 · US FDA — Medical DevicesClass I
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba - 2024-08-08 · US FDA — Medical DevicesClass II
Ziehm Solo. Digital Mobile C-arm - 2024-08-08 · US FDA — Medical DevicesClass II
Ziehm Solo FD. Interventional fluoroscopic x-ray system - 2024-08-08 · US FDA — Medical DevicesClass II
Ziehm Vision RFD. Interventional fluoroscopic x-ray system - 2024-08-08 · US FDA — Medical DevicesClass II
DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere, - 2024-08-08 · US FDA — Medical DevicesClass I
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba - 2024-08-08 · US FDA — Medical DevicesClass II
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, - 2024-08-08 · US FDA — Medical DevicesClass I
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba - 2024-08-08 · US FDA — Medical DevicesClass II
Ziehm Vision system, x-ray, tomography, computed. - 2024-08-08 · US FDA — Medical DevicesClass II
Ziehm Vision R. Iterventional fluoroscopic x-ray system - 2024-08-07 · US FDA — Medical DevicesClass II
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provi - 2024-08-07 · US FDA — Medical DevicesClass II
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W - 2024-08-06 · US FDA — Medical DevicesClass II
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Number - 2024-08-05 · US FDA — Medical DevicesClass II
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; - 2024-08-05 · US FDA — Medical DevicesClass II
Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040; - 2024-08-05 · US FDA — Medical DevicesClass II
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211; - 2024-08-05 · US FDA — Medical DevicesClass II
Pump 381 Pump Set (US); Product Code: 1000080; - 2024-08-05 · US FDA — Medical DevicesClass II
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002; - 2024-08-05 · US FDA — Medical DevicesClass II
Impella CP Smart Assist Set APAC; Product Code: 0048-0047; - 2024-08-05 · US FDA — Medical DevicesClass II
Impella CP Smart Assist Set; Product Code: 1000402; - 2024-08-05 · US FDA — Medical DevicesClass II
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459; - 2024-08-05 · US FDA — Medical DevicesClass II
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100; - 2024-08-02 · US FDA — Medical DevicesClass II
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, M - 2024-08-01 · US FDA — Medical DevicesClass II
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indi - 2024-07-31 · US FDA — Medical DevicesClass I
MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1 - 2024-07-30 · US FDA — Medical DevicesClass II
Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146; - 2024-07-26 · US FDA — Medical DevicesClass II
Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated an - 2024-07-26 · US FDA — Medical DevicesClass II
ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated - 2024-07-26 · US FDA — Medical DevicesClass II
Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associ - 2024-07-26 · US FDA — Medical DevicesClass II
ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated - 2024-07-24 · US FDA — Medical DevicesClass I
FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System - 2024-07-24 · US FDA — Medical DevicesClass II
Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, - 2024-07-24 · US FDA — Medical DevicesClass II
Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorti - 2024-07-24 · US FDA — Medical DevicesClass II
Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling, reaming - 2024-07-24 · US FDA — Medical DevicesClass II
Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decort - 2024-07-24 · US FDA — Medical DevicesClass II
Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming, - 2024-07-24 · US FDA — Medical DevicesClass II
Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, - 2024-07-24 · US FDA — Medical DevicesClass II
Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorti - 2024-07-24 · US FDA — Medical DevicesClass II
Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decor - 2024-07-22 · US FDA — Medical DevicesClass II
Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic - 2024-07-22 · US FDA — Medical DevicesClass II
Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with c - 2024-07-22 · US FDA — Medical DevicesClass II
Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic - 2024-07-22 · US FDA — Medical DevicesClass II
SlideView VS200 slide viewer, - 2024-07-22 · US FDA — Medical DevicesClass II
Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with co - 2024-07-19 · US FDA — Medical DevicesClass I
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thromb - 2024-07-17 · US FDA — Medical DevicesClass II
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320 - 2024-07-17 · US FDA — Medical DevicesClass II
PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.