Browse recalls
Issuing authority: US FDA — Medical Devices
- 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 I
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump - 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 III
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and - 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 - 2024-03-26 · US FDA — Medical DevicesClass I
BiPAP V30 Auto Ventilator, Part Number 1111178 - 2024-03-26 · US FDA — Medical DevicesClass I
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 11111 - 2024-03-26 · US FDA — Medical DevicesClass I
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 11 - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter - 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 - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter - 2024-03-21 · US FDA — Medical DevicesClass I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter - 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 I
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZ - 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 I
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 - 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