Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,633 total recalls
Medline convenience kits containing semi-rigid suction liners labeled as follows: NICU ADMIT KIT, Pack Number DYKA1014G
MEDLINE INDUSTRIES, LP - Northfield
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number
Siemens Medical Solutions USA, Inc
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000866;
Beaver Visitec International, Inc.
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for
Conformis Inc.
Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version
Encore Medical, LP
LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J
LSL Healthcare Inc.
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Veno
Medtronic Perfusion Systems
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048; endoscopic surgical devic
Carefusion 2200 Inc
Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 2
Baxter Healthcare Corporation
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-224
Sklar Instruments
Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number VKITCON001); b) 18155-KIT; radiation mon
Landauer
NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For Trophon EPR Disinfection System
Mckesson Medical-Surgical Inc. Corporate Office
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
Philips North America
Diabetes HbA1c Test
GET TESTED INTERNATIONAL AB
BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW AB
Becton Dickinson & Company
Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring dosimeter used with the microSTA
Landauer
STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular
Stradis Medical, LLC dba Stradis Healthcare
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy S
Noah Medical
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPE
Siemens Medical Solutions USA, Inc
IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients wi
Ion Beam Applications S.A.
Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE Model/Catalog Number: 91841 Product Description: NON-Sterile syr
Jiangsu Shenli Medical Production Co., Ltd.
Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-6
MEDLINE INDUSTRIES, LP - Northfield
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Siemens Healthcare Diagnostics, Inc
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Cat
Quidel Corporation
BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
CareFusion 303, Inc.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47
Medline Industries, LP
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/Li
Smiths Medical ASD Inc.
Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is i
Zyno Medical LLC
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603;
Sklar Instruments
EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
Red Medical Supplies
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