Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Carefusion 303, Inc.
BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedSta...
Medical Devices·27,666 affected·Feb 14, 2023
High RiskFDA
Carefusion 303, Inc.
BD Pyxis MedStation 4000 Main, REF 303
Medical Devices·13,055 affected·Feb 14, 2023
High RiskFDA
Fenwal Inc
Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
Medical Devices·1,614 affected·Feb 14, 2023
High RiskFDA
Coopervision, Inc.
Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
Medical Devices·3,150 affected·Feb 14, 2023
High RiskFDA
Carefusion 303, Inc.
BD Pyxis Med 4000 Auxiliary (AUX), REF 314
Medical Devices·5 affected·Feb 14, 2023
High RiskFDA
Carefusion 303, Inc.
BD Pyxis MedStation ES (Med ES Main), REF 323
Medical Devices·94,466 affected·Feb 14, 2023
High RiskFDA
Coopersurgical, Inc.
Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
Medical Devices·190 affected·Feb 13, 2023
High RiskFDA
Sensus Healthcare, Inc.
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System w...
Medical Devices·23 affected·Feb 10, 2023
High RiskFDA
Deroyal Industries Inc
DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
Medical Devices·27,200 affected·Feb 9, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRA...
Medical Devices·10,037 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S4...
Medical Devices·19,057 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105...
Medical Devices·5,308 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DB...
Medical Devices·4,348 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5C...
Medical Devices·10,090 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF ...
Medical Devices·30,541 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S4...
Medical Devices·37,721 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS...
Medical Devices·23,850 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S431...
Medical Devices·186,889 affected·Feb 8, 2023
High RiskFDA
Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
Medical Devices·8,909 affected·Feb 7, 2023
High RiskFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0...
Medical Devices·11,792 affected·Feb 7, 2023
High RiskFDA
Datascope Corp.
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Medical Devices·47 affected·Feb 7, 2023
CriticalFDA
Datascope Corp.
Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 099...
Medical Devices·4,793 affected·Feb 7, 2023
High RiskFDA
Labories Medical Technologies
injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge
Medical Devices·415,480 affected·Feb 7, 2023
High RiskFDA
Biomet, Inc.
G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
Medical Devices·12 affected·Feb 6, 2023
High RiskFDA
Biomerieux Inc
MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and bl...
Medical Devices·19 affected·Feb 6, 2023
High RiskFDA
Instrumentation Laboratory
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis t...
Medical Devices·1 affected·Feb 3, 2023
High RiskFDA
Instrumentation Laboratory
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. ...
Medical Devices·129 affected·Feb 3, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
Medical Devices·141 affected·Feb 2, 2023
High RiskFDA
Wright Medical Technology, Inc.
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
Medical Devices·4 affected·Feb 2, 2023
High RiskFDA
Boston Scientific Corporation
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Medical Devices·1,531 affected·Feb 2, 2023
RecallFDA
Preat Corp
PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
Medical Devices·652 affected·Feb 1, 2023
High RiskFDA
Synthes (usa) Products Llc
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur...
Medical Devices·6 affected·Feb 1, 2023
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001
Medical Devices·4 affected·Feb 1, 2023
High RiskFDA
Synthes (usa) Products Llc
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur...
Medical Devices·5 affected·Feb 1, 2023
High RiskFDA
Aniara Diagnostica Llc
BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycopr...
Medical Devices·2 affected·Feb 1, 2023
High RiskFDA
Quidel Corporation
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037,...
Medical Devices·771 affected·Feb 1, 2023
High RiskFDA
Baxter Healthcare Corporation
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
Medical Devices·33,866,400 affected·Feb 1, 2023
High RiskFDA
Carefusion 2200 Inc
CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG...
Medical Devices·5,952 affected·Jan 30, 2023
High RiskFDA
Coopervision, Inc.
Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Medical Devices·24 affected·Jan 26, 2023
High RiskFDA
Church & Dwight Inc
Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text ...
Medical Devices·780,000 affected·Jan 25, 2023
High RiskFDA
Limacorporate S.p.a
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Medical Devices·5 affected·Jan 25, 2023
High RiskFDA
Stryker Corporation
Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Medical Devices·88 affected·Jan 25, 2023
CriticalFDA
Covidien, Lp
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Medical Devices·264 affected·Jan 25, 2023
High RiskFDA
Stryker Corporation
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimati...
Medical Devices·541 affected·Jan 25, 2023
High RiskFDA
Carefusion 303, Inc.
Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
Medical Devices·83,185 affected·Jan 24, 2023
CriticalFDA
Draeger Medical, Inc.
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
Medical Devices·893 affected·Jan 23, 2023
CriticalFDA
Draeger Medical, Inc.
NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
Medical Devices·16 affected·Jan 23, 2023
High RiskFDA
Medtronic Neuromodulation
SenSight Connector Plug, Model Number B31061.
Medical Devices·65 affected·Jan 20, 2023