Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Randox Laboratories
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Medical Devices·41 affected·May 4, 2018
High RiskFDA
Stryker Gmbh
Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
Medical Devices·18 affected·May 4, 2018
High RiskFDA
Thermo Fisher
remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qu...
Medical Devices·67 affected·May 4, 2018
High RiskFDA
Synthes (usa) Products Llc
Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
Medical Devices·50 affected·May 4, 2018
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identificatio...
Medical Devices·686 affected·May 4, 2018
High RiskFDA
Smith & Nephew, Inc.
smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
Medical Devices·5 affected·May 4, 2018
CriticalFDA
Maquet Datascope Corp - Cardiac Assist Division
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-080...
Medical Devices·4,300 affected·May 3, 2018
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is ...
Medical Devices·1,060 affected·May 2, 2018
CriticalFDA
The Seaberg Company Inc
Part #: SAM XT-M, Model: Tactical Black or Military
Medical Devices·0 affected·May 2, 2018
High RiskFDA
Galt Medical Corporation
Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-...
Medical Devices·23,777 affected·May 2, 2018
CriticalFDA
The Seaberg Company Inc
Part #: SAM XT-C, Model: Hi-Viz Blue
Medical Devices·0 affected·May 2, 2018
High RiskFDA
Galt Medical Corporation
Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055
Medical Devices·10,950 affected·May 2, 2018
High RiskFDA
Stryker Neurovascular
AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made ...
Medical Devices·15 affected·May 2, 2018
High RiskFDA
Roche Molecular Systems, Inc.
MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It e...
Medical Devices·163 affected·May 2, 2018
High RiskFDA
Galt Medical Corporation
1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Perip...
Medical Devices·8,350 affected·May 2, 2018
High RiskFDA
Galt Medical Corporation
1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-...
Medical Devices·3,160 affected·May 2, 2018
High RiskFDA
Ad-tech Medical Instrument Corporation
AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from ...
Medical Devices·65 affected·May 2, 2018
High RiskFDA
Tp Orthodontics, Inc.
Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for correcting class 2 malocclusions by applying light forces on the...
Medical Devices·1 affected·May 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures.
Medical Devices·1 affected·May 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q.zeego, Material no. 10848283, for angiography and whole body radiographic/fluoroscopic procedures.
Medical Devices·4 affected·May 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q biplane, Material no. 10848282, for angiography and whole body radiographic/fluoroscopic procedures.
Medical Devices·5 affected·May 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures.
Medical Devices·5 affected·May 1, 2018
High RiskFDA
Hobbs Medical, Inc.
Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through...
Medical Devices·1,820 affected·May 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
Medical Devices·39 affected·May 1, 2018
High RiskFDA
Tp Orthodontics, Inc.
Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for correcting class 2 malocclusions by applying light forces on the ...
Medical Devices·5 affected·May 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee biplane MN, Material no. 10094143, for angiography and whole body radiographic/fluoroscopic procedures.
Medical Devices·2 affected·May 1, 2018
High RiskFDA
Tp Orthodontics, Inc.
Jasper Vektor, Class II Correction Appliance, Part No. 610-536L used for correcting class 2 malocclusions by applying light forces on the...
Medical Devices·1 affected·May 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.
Medical Devices·56 affected·May 1, 2018
High RiskFDA
Tp Orthodontics, Inc.
Jasper Vektor, Class II Correction Appliance, Part No. 610-533 used for correcting class 2 malocclusions by applying light forces on the ...
Medical Devices·119 affected·May 1, 2018
High RiskFDA
Tp Orthodontics, Inc.
Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for correcting class 2 malocclusions by applying light forces on the ...
Medical Devices·126 affected·May 1, 2018
High RiskFDA
Philips Electronics North America Corporation
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352
Medical Devices·4,488 affected·Apr 30, 2018
High RiskFDA
Philips Electronics North America Corporation
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
Medical Devices·25,499 affected·Apr 30, 2018
High RiskFDA
Stryker Gmbh
Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
Medical Devices·2 affected·Apr 27, 2018
High RiskFDA
Stryker Gmbh
Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S
Medical Devices·0 affected·Apr 27, 2018
High RiskFDA
Stryker Gmbh
Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S
Medical Devices·0 affected·Apr 27, 2018
High RiskFDA
Stryker Gmbh
Femoral Nail, A/R, R1500 T2 Femur ¿12x360 mm, Product Number 18281236S
Medical Devices·0 affected·Apr 27, 2018
High RiskFDA
Stryker Gmbh
Femoral Nail, LEFT T2 GTN ¿14x300 mm, Product Number 18501430S
Medical Devices·0 affected·Apr 27, 2018
High RiskFDA
Stryker Gmbh
Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S
Medical Devices·0 affected·Apr 27, 2018
High RiskFDA
Ge Healthcare Japan Corporation
GE Healthcare Optima CT660. Sold under the following product names: BEIJING OPTIMA CT660 PRO GT170, BEIJING OPTIMA CT660 PRO GT200,...
Medical Devices·4,007 affected·Apr 27, 2018
High RiskFDA
Stryker Gmbh
Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S
Medical Devices·0 affected·Apr 27, 2018
High RiskFDA
Stryker Gmbh
Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S
Medical Devices·17 affected·Apr 27, 2018
High RiskFDA
Stryker Gmbh
Femoral Nail, A/R T2 Femur ¿15x240 mm, Product Number 18251524S
Medical Devices·1 affected·Apr 27, 2018
High RiskFDA
Stryker Gmbh
Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S
Medical Devices·0 affected·Apr 27, 2018
High RiskFDA
Stryker Gmbh
Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S
Medical Devices·7 affected·Apr 27, 2018
High RiskFDA
Stryker Gmbh
Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S
Medical Devices·0 affected·Apr 27, 2018
High RiskFDA
Covidien Medtronic
BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-st...
Medical Devices·169,775 affected·Apr 26, 2018
High RiskFDA
Covidien Medtronic
(1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII (Item Number HEMIGX1 ZESTAW DO HEMICOLECTOMII) (2) BOX LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI...
Medical Devices·171,271 affected·Apr 26, 2018
High RiskFDA
Horiba Instruments, Inc Dba Horiba Medical
ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to ...
Medical Devices·686 affected·Apr 26, 2018