Browse recalls
Alert level: Class II
- 2024-06-14 · US FDA — Medical DevicesClass II
3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16 - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System - 2024-06-13 · US FDA — Medical DevicesClass II
Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus - 2024-06-13 · US FDA — Medical DevicesClass II
Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" A - 2024-06-13 · US FDA — Medical DevicesClass II
Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus - 2024-06-05 · US FDA — Medical DevicesClass II
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in sampl - 2024-06-04 · US FDA — Medical DevicesClass II
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical - 2024-06-04 · US FDA — Medical DevicesClass II
iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Ligh - 2024-06-04 · US FDA — Medical DevicesClass II
VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) - 2024-06-03 · US FDA — Medical DevicesClass II
Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of - 2024-06-03 · US FDA — Medical DevicesClass II
QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecu - 2024-06-03 · US FDA — Medical DevicesClass II
Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), R - 2024-05-31 · US FDA — Medical DevicesClass II
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of sa - 2024-05-31 · US FDA — Medical DevicesClass II
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Leng - 2024-05-29 · US FDA — Medical DevicesClass II
Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular P - 2024-05-29 · US FDA — Medical DevicesClass II
Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog - 2024-05-23 · US FDA — Medical DevicesClass II
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399 - 2024-05-23 · US FDA — Medical DevicesClass II
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910 - 2024-05-23 · US FDA — Medical DevicesClass II
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900 - 2024-05-22 · US FDA — Medical DevicesClass II
2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-9 - 2024-05-17 · US FDA — Medical DevicesClass II
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e - 2024-05-16 · US FDA — Medical DevicesClass II
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY - 2024-05-14 · US FDA — Medical DevicesClass II
VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged - 2024-05-13 · US FDA — Medical DevicesClass II
BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ - 2024-05-13 · US FDA — Medical DevicesClass II
BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 1 - 2024-05-10 · US FDA — Medical DevicesClass II
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), - 2024-05-09 · US FDA — Medical DevicesClass II
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual - 2024-05-09 · US FDA — Medical DevicesClass II
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasoun - 2024-05-02 · US FDA — Medical DevicesClass II
GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW - 2024-05-02 · US FDA — Medical DevicesClass II
BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES - 2024-04-26 · US FDA — Medical DevicesClass II
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients - 2024-04-24 · US FDA — Medical DevicesClass II
Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software - 2024-04-24 · US FDA — Medical DevicesClass II
MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display - 2024-04-24 · US FDA — Medical DevicesClass II
Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software - 2024-04-23 · US FDA — Medical DevicesClass II
Trevo ProVue, Catalog: 90184 - 2024-04-23 · US FDA — Medical DevicesClass II
Trevo Trak 21 Microcatheter, Catalog: 90338 - 2024-04-23 · US FDA — Medical DevicesClass II
Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNC - 2024-04-23 · US FDA — Medical DevicesClass II
DAC 044 115cm, Catalog: 90760 - 2024-04-22 · US FDA — Medical DevicesClass II
Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10 - 2024-04-22 · US FDA — Medical DevicesClass II
Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part N - 2024-04-22 · US FDA — Medical DevicesClass II
Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medi - 2024-04-22 · US FDA — Medical DevicesClass II
Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biote - 2024-04-18 · US FDA — Medical DevicesClass II
The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shap - 2024-04-18 · US FDA — Medical DevicesClass II
DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic - 2024-04-18 · US FDA — Medical DevicesClass II
The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and p - 2024-04-18 · US FDA — Medical DevicesClass II
The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro - 2024-04-17 · US FDA — Medical DevicesClass II
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Inte - 2024-04-15 · US FDA — Medical DevicesClass II
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthropl - 2024-04-15 · US FDA — Medical DevicesClass II
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthropl - 2024-04-15 · US FDA — Medical DevicesClass II
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthropl - 2024-04-15 · US FDA — Medical DevicesClass II
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthropl - 2024-04-11 · US FDA — Medical DevicesClass II
Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a - 2024-04-09 · US FDA — Medical DevicesClass II
The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial - 2024-04-09 · US FDA — Medical DevicesClass II
The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial - 2024-04-09 · US FDA — Medical DevicesClass II
VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative meas - 2024-04-08 · US FDA — Medical DevicesClass II
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P - 2024-04-05 · US FDA — Medical DevicesClass II
CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e - 2024-04-05 · US FDA — Medical DevicesClass II
CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01 - 2024-04-05 · US FDA — Medical DevicesClass II
CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 20786 - 2024-04-05 · US FDA — Medical DevicesClass II
CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001- - 2024-04-04 · US FDA — Medical DevicesClass II
Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific - 2024-04-02 · US FDA — Medical DevicesClass II
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US - 2024-04-01 · US FDA — Medical DevicesClass II
LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000 - 2024-03-27 · US FDA — Medical DevicesClass II
Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as - 2024-03-21 · US FDA — Medical DevicesClass II
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 1 - 2024-03-20 · US FDA — Medical DevicesClass II
ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated - 2024-03-20 · US FDA — Medical DevicesClass II
ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and sta - 2024-03-20 · US FDA — Medical DevicesClass II
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 16 Holes, 236 MM, Sterile- Indicate - 2024-03-20 · US FDA — Medical DevicesClass II
ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for temporary internal fixation and stabil - 2024-03-20 · US FDA — Medical DevicesClass II
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Sterile- Indicat - 2024-03-20 · US FDA — Medical DevicesClass II
ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and sta - 2024-03-20 · US FDA — Medical DevicesClass II
ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stab - 2024-03-20 · US FDA — Medical DevicesClass II
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Sterile- Indicated - 2024-03-20 · US FDA — Medical DevicesClass II
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM, Sterile- Indicat - 2024-03-20 · US FDA — Medical DevicesClass II
Alinity m System, Part Number: 08N53-002 - 2024-03-20 · US FDA — Medical DevicesClass II
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated - 2024-03-20 · US FDA — Medical DevicesClass II
ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabi - 2024-03-20 · US FDA — Medical DevicesClass II
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM, Sterile- Indicat - 2024-03-20 · US FDA — Medical DevicesClass II
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Sterile- Indicat - 2024-03-20 · US FDA — Medical DevicesClass II
ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Sterile- Indicate - 2024-03-18 · US FDA — Medical DevicesClass II
GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems - 2024-03-18 · US FDA — Medical DevicesClass II
LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the Li - 2024-03-18 · US FDA — Medical DevicesClass II
GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems - 2024-03-18 · US FDA — Medical DevicesClass II
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems - 2024-03-18 · US FDA — Medical DevicesClass II
GE Healthcare Innova IGS 5, computed tomography x-ray system - 2024-03-18 · US FDA — Medical DevicesClass II
GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems - 2024-03-14 · US FDA — Medical DevicesClass II
Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The ir - 2024-03-13 · US FDA — Medical DevicesClass II
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodiu - 2024-03-11 · US FDA — Medical DevicesClass II
HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's f - 2024-03-07 · US FDA — Medical DevicesClass II
POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such sur - 2024-03-06 · US FDA — Medical DevicesClass II
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 - 2024-03-06 · US FDA — Medical DevicesClass II
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, - 2024-03-06 · US FDA — Medical DevicesClass II
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty - 2024-03-06 · US FDA — Medical DevicesClass II
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number - 2024-03-06 · US FDA — Medical DevicesClass II
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty - 2024-03-06 · US FDA — Medical DevicesClass II
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13- - 2024-03-06 · US FDA — Medical DevicesClass II
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Nu - 2024-03-06 · US FDA — Medical DevicesClass II
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b - 2024-03-06 · US FDA — Medical DevicesClass II
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314 - 2024-03-06 · US FDA — Medical DevicesClass II
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item