Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Cook Inc.
StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606;...
Medical Devices·12,556 affected·Jan 31, 2018
High RiskFDA
Cook Inc.
StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
Medical Devices·470 affected·Jan 31, 2018
High RiskFDA
Cook Inc.
StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044
Medical Devices·751 affected·Jan 31, 2018
High RiskFDA
3m Company - Health Care Business
FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6
Medical Devices·158,179 affected·Jan 31, 2018
High RiskFDA
Encore Medical, Lp
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder ...
Medical Devices·92 affected·Jan 29, 2018
High RiskFDA
Encore Medical, Lp
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoul...
Medical Devices·93 affected·Jan 29, 2018
High RiskFDA
Encore Medical, Lp
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder ...
Medical Devices·92 affected·Jan 29, 2018
High RiskFDA
Ion Beam Applications S.a.
Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other...
Medical Devices·5 affected·Jan 26, 2018
High RiskFDA
Raysearch Laboratories Ab
Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, ...
Medical Devices·2,484 affected·Jan 26, 2018
High RiskFDA
Ge Healthcare
Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays me...
Medical Devices·44 affected·Jan 25, 2018
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L container), (2) 105...
Medical Devices·4,838 affected·Jan 24, 2018
High RiskFDA
Livanova Usa Inc
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Medical Devices·243 affected·Jan 24, 2018
High RiskFDA
Invivo Corporation
DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of Dyn...
Medical Devices·470 affected·Jan 24, 2018
High RiskFDA
3m Company - Health Care Business
3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management Sys...
Medical Devices·33,108 affected·Jan 23, 2018
High RiskFDA
3m Company - Health Care Business
3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The 3M Bair Hugger Temperature Management System is...
Medical Devices·36 affected·Jan 23, 2018
High RiskFDA
Aesculap Implant Systems Llc
DS Titanium Ligation Clip, used in laparoscopic surgery
Medical Devices·9,621 affected·Jan 22, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
Medical Devices·38 affected·Jan 18, 2018
High RiskFDA
Beckman Coulter Inc.
AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample proce...
Medical Devices·73 affected·Jan 18, 2018
High RiskFDA
Neuropro Spinal Jaxx
Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx interbody fusion devic...
Medical Devices·6 affected·Jan 18, 2018
High RiskFDA
Olympus Corporation Of The Americas
Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R
Medical Devices·2,548 affected·Jan 17, 2018
High RiskFDA
Olympus Corporation Of The Americas
Uretero-reno fiberscope URF-P6RP6
Medical Devices·2,399 affected·Jan 17, 2018
High RiskFDA
Olympus Corporation Of The Americas
Uretero-reno fiberscope URF-P6
Medical Devices·1,062 affected·Jan 17, 2018
High RiskFDA
Medtronic Perfusion Systems
Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Fi...
Medical Devices·8,644 affected·Jan 16, 2018
High RiskFDA
Smith & Nephew, Inc.
LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are ...
Medical Devices·12 affected·Jan 15, 2018
High RiskFDA
Medline Industries, Inc.
BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.
Medical Devices·6 affected·Jan 12, 2018
High RiskFDA
Cook Inc.
MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator inte...
Medical Devices·4,451 affected·Jan 12, 2018
High RiskFDA
Shimadzu Medical Systems
Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiogra...
Medical Devices·17 affected·Jan 12, 2018
High RiskFDA
Alcon Research, Ltd.
Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION V...
Medical Devices·300 affected·Jan 12, 2018
High RiskFDA
Hill-rom, Inc.
Progressa Bed - AC-powered adjustable hospital bed
Medical Devices·2,117 affected·Jan 12, 2018
High RiskFDA
Alcon Research, Ltd.
Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) Includes all necessary items for a core vitrec...
Medical Devices·52 affected·Jan 12, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Medical Devices·63 affected·Jan 11, 2018
High RiskFDA
Ethicon, Inc.
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
Medical Devices·7,020 affected·Jan 10, 2018
High RiskFDA
Ethicon, Inc.
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
Medical Devices·180 affected·Jan 10, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a st...
Medical Devices·165 affected·Jan 10, 2018
CriticalFDA
Magellan Diagnostics, Inc.
LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.
Medical Devices·6,143 affected·Jan 9, 2018
CriticalFDA
Magellan Diagnostics, Inc.
LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.
Medical Devices·79 affected·Jan 9, 2018
RecallFDA
Riverpoint Medical, Llc
RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brach...
Medical Devices·443 affected·Jan 9, 2018
High RiskFDA
Innovasis, Inc
Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization an...
Medical Devices·1,010 affected·Jan 8, 2018
High RiskFDA
Getinge Us Sales Llc
HEMASHIELD Knitted Double Velour Cardiovascular Fabric
Medical Devices·1 affected·Jan 3, 2018
High RiskFDA
Philips Electronics North America Corporation
Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PI...
Medical Devices·20,357 affected·Jan 3, 2018
High RiskFDA
Esaote S.p.a.
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E,...
Medical Devices·5 affected·Jan 3, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur¿ DHEA-SO4
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
Medical Devices·0 affected·Jan 2, 2018