Browse recalls
Alert level: Class II
- 2024-09-20 · US FDA — Medical DevicesClass II
Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ002-02 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-29 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-19 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard PACK, MINOR - Medical convenience kits Model Number: VMED018-02 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02 - 2024-09-20 · US FDA — Medical DevicesClass II
Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02 - 2024-09-19 · US FDA — Medical DevicesClass II
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode - 2024-09-18 · US FDA — Medical DevicesClass II
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic ca - 2024-09-17 · US FDA — Medical DevicesClass II
Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access fo - 2024-09-17 · US FDA — Medical DevicesClass II
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Pos - 2024-09-13 · US FDA — Medical DevicesClass II
EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilat - 2024-09-12 · US FDA — Medical DevicesClass II
Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF - 2024-09-12 · US FDA — Medical DevicesClass II
Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF - 2024-09-06 · US FDA — Medical DevicesClass II
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical - 2024-09-05 · US FDA — Medical DevicesClass II
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes a - 2024-09-05 · US FDA — Medical DevicesClass II
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an - 2024-09-05 · US FDA — Medical DevicesClass II
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468 - 2024-09-05 · US FDA — Medical DevicesClass II
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive - 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 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. - 2024-08-15 · 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;