Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Merit Medical Systems, Inc.
Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom procedural tray is a c...
Medical Devices·83 affected·Jun 8, 2012
RecallFDA
Integra Lifesciences Corp. D.b.a. Integra Pain Management
Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs ...
Medical Devices·4 affected·Jun 7, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens syngo.plaza radiological image processing system.
Medical Devices·11 affected·Jun 6, 2012
High RiskFDA
Zoe Medical Incorporated
Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals fo...
Medical Devices·35 affected·Jun 6, 2012
High RiskFDA
Advanced Sterilization Products
CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended...
Medical Devices·1,310,844 affected·Jun 1, 2012
High RiskFDA
Biomet 3i, Llc
Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed...
Medical Devices·611 affected·May 31, 2012
High RiskFDA
Maquet Inc.
Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 ...
Medical Devices·20 affected·May 29, 2012
CriticalFDA
Carefusion 303, Inc.
Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.
Medical Devices·112,912 affected·May 25, 2012
High RiskFDA
Getinge Usa Inc
Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and d...
Medical Devices·8 affected·May 25, 2012
High RiskFDA
Ge Healthcare, Llc
GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or ...
Medical Devices·70 affected·May 24, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows eas...
Medical Devices·12 affected·May 24, 2012
High RiskFDA
Integra Limited
Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in...
Medical Devices·108 affected·May 23, 2012
High RiskFDA
Lma North America Inc
LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotrac...
Medical Devices·18,799 affected·May 23, 2012
CriticalFDA
Alere San Diego, Inc.
Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and ...
Medical Devices·16,962 affected·May 22, 2012
High RiskFDA
Beckman Coulter Inc.
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of to...
Medical Devices·137,445 affected·May 22, 2012
CriticalFDA
Alere San Diego, Inc.
Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic p...
Medical Devices·5,013 affected·May 22, 2012
High RiskFDA
Synthes Usa Hq, Inc.
4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101...
Medical Devices·20 affected·May 22, 2012
High RiskFDA
Beckman Coulter Inc.
TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+...
Medical Devices·146 affected·May 22, 2012
CriticalFDA
Alere San Diego, Inc.
Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coa...
Medical Devices·1,972 affected·May 22, 2012
High RiskFDA
Synthes Usa Hq, Inc.
4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101...
Medical Devices·20 affected·May 22, 2012
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variet...
Medical Devices·1,387 affected·May 21, 2012
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety...
Medical Devices·77 affected·May 21, 2012
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of anal...
Medical Devices·2,044 affected·May 21, 2012
High RiskFDA
Stryker Medical Division Of Stryker Corporation
GoBed+ . Model FL20E Beds are intended for medical purposes in both general patient care as well as critical care environments. Each u...
Medical Devices·6,325 affected·May 17, 2012
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Stryker Rose Bed Model (FL14E) Beds are intended for medical purposes in both general patient care as well as critical care environme...
Medical Devices·999 affected·May 17, 2012
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environme...
Medical Devices·2,546 affected·May 17, 2012
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Go Bed II+ Model FL28C Beds are intended for medical purposes in both general patient care as well as critical care environments. Eac...
Medical Devices·8,009 affected·May 17, 2012
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Go Bed II+ Model FL 28 Ex Beds are intended for medical purposes in both general patient care as well as critical care environments. ...
Medical Devices·9,440 affected·May 17, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
LUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems ...
Medical Devices·85 affected·May 16, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems we...
Medical Devices·85 affected·May 16, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
LUSTER HIP SZ 9 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems ...
Medical Devices·85 affected·May 16, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Ty...
Medical Devices·431 affected·May 16, 2012
High RiskFDA
Boston Scientific Corporation
Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Po...
Medical Devices·1,970 affected·May 16, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
LUSTER HIP SZ 5 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems ...
Medical Devices·85 affected·May 16, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyv...
Medical Devices·431 affected·May 16, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
ULTIMA*LX STM,POL 10/12TAP/2M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyv...
Medical Devices·431 affected·May 16, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
ULTIMA*LX STM,POL 10/12TAP/1M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyv...
Medical Devices·431 affected·May 16, 2012
High RiskFDA
Boston Scientific Corporation
Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile P...
Medical Devices·2,760 affected·May 16, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
LUSTER HIP SZ 10 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems...
Medical Devices·85 affected·May 16, 2012
High RiskFDA
Boston Scientific Corporation
Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inner Pouch: M00562570 The single-use Profile Po...
Medical Devices·1,340 affected·May 16, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
ULTIMA*LX STM,POL 10/12TAP/SZ4 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Ty...
Medical Devices·431 affected·May 16, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
LUSTER HIP SZ 6 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems ...
Medical Devices·85 affected·May 16, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
LUSTER HIP SZ 7 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems ...
Medical Devices·85 affected·May 16, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
ULTIMA*LX STM,POL 10/12TAP/SZ3 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Ty...
Medical Devices·431 affected·May 16, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
LUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems ...
Medical Devices·85 affected·May 16, 2012
High RiskFDA
Polymer Technology Systems, Inc.
PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine mea...
Medical Devices·1,650 affected·May 15, 2012
High RiskFDA
Hartmann Usa, Inc
Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debr...
Medical Devices·101,546,391 affected·May 14, 2012
High RiskFDA
Spacelabs Healthcare, Llc
The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0...
Medical Devices·114 affected·May 11, 2012