Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
(Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Medical Devices·5,800 affected·Feb 4, 2016
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer t...
Medical Devices·5,800 affected·Feb 4, 2016
High RiskFDA
Medical Action Industries Inc
PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. This kit is...
Medical Devices·9 affected·Feb 3, 2016
High RiskFDA
Zimmer Spine, Inc.
Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
Medical Devices·15,753 affected·Feb 3, 2016
High RiskFDA
Stryker Medical Division Of Stryker Corporation
S3 MedSurg Bed, Model 3005. Stryker Medical
Medical Devices·8,490 affected·Feb 2, 2016
High RiskFDA
Laserex Systems Inc.
Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery hea...
Medical Devices·72 affected·Feb 1, 2016
High RiskFDA
Merge Healthcare, Inc.
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·25 affected·Jan 31, 2016
High RiskFDA
Merge Healthcare, Inc.
iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended fo...
Medical Devices·96 affected·Jan 30, 2016
High RiskFDA
Merge Healthcare, Inc.
CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·844 affected·Jan 30, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate c...
Medical Devices·324 affected·Jan 30, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional an...
Medical Devices·109 affected·Jan 30, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, ...
Medical Devices·151 affected·Jan 29, 2016
High RiskFDA
Novadaq Technologies Inc.
PINPOINT Endoscopic Fluorescence Imaging System
Medical Devices·110 affected·Jan 29, 2016
High RiskFDA
Valeant Pharmacueticals International
Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The ...
Medical Devices·7,716 affected·Jan 29, 2016
High RiskFDA
Corin Usa Limited
Trinity Acetabular System Product Usage - Total Hip Replacement.
Medical Devices·629 affected·Jan 29, 2016
High RiskFDA
Corin Usa Limited
Trinity Acetabular Shell Product Usage Total Hip Replacement.
Medical Devices·629 affected·Jan 29, 2016
High RiskFDA
Gi Supply
Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed ste...
Medical Devices·390 affected·Jan 28, 2016
High RiskFDA
Conformis, Inc.
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
Medical Devices·1 affected·Jan 28, 2016
High RiskFDA
Karman Healthcare Inc
Karma Flexx Wheelchair Manual Wheelchair.
Medical Devices·35 affected·Jan 27, 2016
High RiskFDA
Applied Medical Technology Inc
AMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For use in patients who canno...
Medical Devices·20 affected·Jan 26, 2016
High RiskFDA
Qig Group Llc
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
Medical Devices·31 affected·Jan 26, 2016
High RiskFDA
Covidien Llc
Covidien Dover PREM U/M 14FR TMP SNS CSD Item Code: P4P14TSD P400 Castile soap towelettes are used to clean the genital area for mal...
Medical Devices·3,000 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes are used to clean the genital area for male an...
Medical Devices·31,200 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Item Code: P18ULD Castile soap towelettes are used to clean the genital area for ma...
Medical Devices·1,980 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Item Code: P4P18CSD Castile soap towelettes are used to clean the genital are...
Medical Devices·600 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: ¿¿¿ P4P18XSD Castile soap towelettes are used to clean the genital area for male...
Medical Devices·4,500 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile soap towelettes are used to clean the genital area for male ...
Medical Devices·3,600 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 16FR SIL COUDE CATH SECURE Item Code: P4P16CSD Castile soap towelettes are used to clean the genital a...
Medical Devices·4,200 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the genital area for male and f...
Medical Devices·95,700 affected·Jan 22, 2016
High RiskFDA
3m Company - Health Care Business
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
Medical Devices·74 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile soap towelettes are used to clean the genital are...
Medical Devices·1,950 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile soap towelettes are used to clean the genital area for male an...
Medical Devices·25,080 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 UM 18FR SIL COUDE SECURE Item Code: P4P18CSDK Castile soap towelettes are used to clean the genital area for mal...
Medical Devices·11,400 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP Item Code: 24035 Castile soap towelettes are used to clean the genital area for male and fe...
Medical Devices·0 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover EASY CATCH MIDSTREAM KT W/CAST Item Code: 25015 Castile soap towelettes are used to clean the genital area for male a...
Medical Devices·74,300 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 UM 16FR SIL COUDE SECURE Item Code: P4P16CSDK Castile soap towelettes are used to clean the genital area for male...
Medical Devices·71,430 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Item Code: P4P16TSD Castile soap towelettes are used to clean the genital area for male ...
Medical Devices·7,200 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD ¿ ¿¿ Castile soap towelettes are used to clean the genital area for m...
Medical Devices·1,320 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 18FR SIL FLY Item Code: P4P18SD Castile soap towelettes are used to clean the genital area for male a...
Medical Devices·7,200 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL Item Code: 24015 Castile soap towelettes are used to clean the genital area for male an...
Medical Devices·16,500 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 18FR UL FOLY CSD Item Code: P4P18ULD Castile soap towelettes are used to clean the genital area for mal...
Medical Devices·600 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap towelettes are used to clean the genital area for male and f...
Medical Devices·83,400 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover MIDSTREAM KIT RING CASTILE Item Code: 4090SA Castile soap towelettes are used to clean the genital area for male and f...
Medical Devices·207,000 affected·Jan 22, 2016
High RiskFDA
Accuray Incorporated
CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery ...
Medical Devices·226 affected·Jan 22, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Medical Devices·147,838 affected·Jan 21, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Medical Devices·147,838 affected·Jan 21, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Medical Devices·147,838 affected·Jan 21, 2016
High RiskFDA
Covidien Llc
Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile; Catalog ...
Medical Devices·1,010 affected·Jan 21, 2016