Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Medline Industries Inc
RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case; Sterile - Produ...
Medical Devices·15,780 affected·Nov 5, 2020
High RiskFDA
K2m, Inc
Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by rocking the instrumen...
Medical Devices·197 affected·Nov 4, 2020
High RiskFDA
Ga Health Company Limited
ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product C...
Medical Devices·100,000 affected·Nov 3, 2020
High RiskFDA
Ga Health Company Limited
Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846
Medical Devices·50 affected·Nov 3, 2020
High RiskFDA
K2m, Inc
Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides ...
Medical Devices·4 affected·Nov 3, 2020
High RiskFDA
Kowa Optimed Inc
Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicat...
Medical Devices·0 affected·Nov 3, 2020
High RiskFDA
Neosteo
Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
Medical Devices·25 affected·Nov 3, 2020
High RiskFDA
Ga Health Company Limited
Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004
Medical Devices·6,470 affected·Nov 3, 2020
High RiskFDA
Ga Health Company Limited
Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046
Medical Devices·93,700 affected·Nov 3, 2020
High RiskFDA
Chromsystems Instruments & Chemicals Gmbh
MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screen...
Medical Devices·362 affected·Nov 2, 2020
High RiskFDA
Chromsystems Instruments & Chemicals Gmbh
3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic screening, confirm...
Medical Devices·200 affected·Nov 2, 2020
High RiskFDA
Chromsystems Instruments & Chemicals Gmbh
MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic scre...
Medical Devices·342 affected·Nov 2, 2020
High RiskFDA
Neocis, Inc.
DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (...
Medical Devices·100 affected·Oct 30, 2020
High RiskFDA
Luminex Corporation
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
Medical Devices·17,110 affected·Oct 30, 2020
High RiskFDA
Luminex Corporation
Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
Medical Devices·24,338 affected·Oct 30, 2020
High RiskFDA
Chromsystems Instruments & Chemicals Gmbh
6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for pati...
Medical Devices·148 affected·Oct 29, 2020
High RiskFDA
Chromsystems Instruments & Chemicals Gmbh
MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor ...
Medical Devices·850 affected·Oct 29, 2020
High RiskFDA
Ge Healthcare, Llc
MAC VU360, Electrocardiograph
Medical Devices·5,284 affected·Oct 27, 2020
High RiskFDA
Mako Surgical Corporation
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA ...
Medical Devices·367 affected·Oct 23, 2020
High RiskFDA
Medtronic Heart Valves Division
Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLU...
Medical Devices·71,030 affected·Oct 23, 2020
High RiskFDA
Hardy Diagnostics
Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic...
Medical Devices·686,920 affected·Oct 23, 2020
High RiskFDA
Medtronic Heart Valves Division
Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS...
Medical Devices·19,961 affected·Oct 23, 2020
High RiskFDA
Hubo International Inc
VGlove NITRILE *** Protect Your Life 100 Patient examination gloves
Medical Devices·28,450 affected·Oct 23, 2020
CriticalFDA
Viewray, Inc.
ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in ...
Medical Devices·3 affected·Oct 20, 2020
CriticalFDA
Viewray, Inc.
ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Inp...
Medical Devices·35 affected·Oct 20, 2020
High RiskFDA
Coltene Whaledent Inc
CEI Cutting Edge Instruments (PTC-57C)
Medical Devices·556 affected·Oct 20, 2020
High RiskFDA
Coltene Whaledent Inc
FG 57 100057X (100057X)
Medical Devices·556 affected·Oct 20, 2020
High RiskFDA
Coltene Whaledent Inc
Alpen Clinic 100 Carbide Instruments (R100057C)
Medical Devices·556 affected·Oct 20, 2020
High RiskFDA
Coltene Whaledent Inc
Clinic Pack 100 Pieces FG 57 100057C (100057C)
Medical Devices·556 affected·Oct 20, 2020
High RiskFDA
Mevion Medical Systems, Inc.
MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients ...
Medical Devices·8 affected·Oct 19, 2020
High RiskFDA
Olympus Corporation Of The Americas
Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time...
Medical Devices·1,297 affected·Oct 16, 2020
High RiskFDA
Olympus Corporation Of The Americas
Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for endoscopic ultrasonic imaging of the gastrointestinal ...
Medical Devices·2,691 affected·Oct 16, 2020
High RiskFDA
Avanos Medical, Inc.
CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
Medical Devices·710 affected·Oct 16, 2020
High RiskFDA
Olympus Corporation Of The Americas
Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic real-time ultras...
Medical Devices·27 affected·Oct 16, 2020
High RiskFDA
Olympus Corporation Of The Americas
Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video Syst...
Medical Devices·31 affected·Oct 16, 2020
High RiskFDA
Ra Medical Systems, Inc.
DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: ...
Medical Devices·36 affected·Oct 16, 2020
High RiskFDA
Roi Cps Llc
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
Medical Devices·220 affected·Oct 12, 2020
High RiskFDA
Primus Corporation
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
Medical Devices·97 affected·Oct 9, 2020
RecallFDA
Talladium Inc
Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. A...
Medical Devices·10 affected·Oct 9, 2020
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configu...
Medical Devices·40 affected·Oct 9, 2020
High RiskFDA
Enterix, Inc.
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal sample...
Medical Devices·5,256 affected·Oct 8, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1,...
Medical Devices·2,768 affected·Oct 8, 2020
High RiskFDA
Microbiologics Inc
Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is s...
Medical Devices·1 affected·Oct 8, 2020
RecallFDA
Microbiologics Inc
KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
Medical Devices·187 affected·Oct 8, 2020
RecallFDA
Hardy Diagnostics
Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
Medical Devices·8,620 affected·Oct 6, 2020
High RiskFDA
Exactech, Inc.
Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
Medical Devices·69 affected·Oct 6, 2020
High RiskFDA
Micro-tech Usa
Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endo...
Medical Devices·2,420 affected·Oct 5, 2020
High RiskFDA
Tytek Medical Inc
TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from ...
Medical Devices·439,146 affected·Oct 5, 2020