Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Arjo Hospital Equipment Ab
Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pr...
Medical Devices·1,034 affected·Sep 1, 2014
High RiskFDA
Motion Concepts
TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.
Medical Devices·59 affected·Aug 28, 2014
High RiskFDA
Merge Healthcare, Inc.
eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). ...
Medical Devices·2,630 affected·Aug 28, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull...
Medical Devices·62 affected·Aug 27, 2014
High RiskFDA
Mast Biosurgery Usa, Inc
The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 (17) 170731(10)52804 LOT 52804 2017-...
Medical Devices·49 affected·Aug 26, 2014
High RiskFDA
Navilyst Medical, Inc
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catal...
Medical Devices·54 affected·Aug 25, 2014
High RiskFDA
Becton Dickinson & Co.
EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . P...
Medical Devices·115 affected·Aug 25, 2014
High RiskFDA
Navilyst Medical, Inc
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0...
Medical Devices·3 affected·Aug 25, 2014
High RiskFDA
Navilyst Medical, Inc
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE ---...
Medical Devices·65 affected·Aug 25, 2014
High RiskFDA
Navilyst Medical, Inc
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1...
Medical Devices·3 affected·Aug 25, 2014
High RiskFDA
Navilyst Medical, Inc
BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catal...
Medical Devices·300 affected·Aug 25, 2014
High RiskFDA
Navilyst Medical, Inc
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0...
Medical Devices·60 affected·Aug 25, 2014
High RiskFDA
Navilyst Medical, Inc
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1...
Medical Devices·45 affected·Aug 25, 2014
High RiskFDA
Beckman Coulter Inc.
Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as ...
Medical Devices·46,050 affected·Aug 25, 2014
High RiskFDA
Deroyal Industries Inc
Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS...
Medical Devices·13,900 affected·Aug 22, 2014
CriticalFDA
Icu Medical, Inc.
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9...
Medical Devices·1,250 affected·Aug 19, 2014
CriticalFDA
Icu Medical, Inc.
83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usag...
Medical Devices·100 affected·Aug 19, 2014
CriticalFDA
Icu Medical, Inc.
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9...
Medical Devices·3,750 affected·Aug 19, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and mu...
Medical Devices·858 affected·Aug 19, 2014
High RiskFDA
Elekta, Inc.
FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also ...
Medical Devices·554 affected·Aug 18, 2014
High RiskFDA
Lumenis, Inc.
Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocula...
Medical Devices·16 affected·Aug 15, 2014
High RiskFDA
Medtronic Cardiovascular Surgery-the Heart Valve Division
Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model...
Medical Devices·2 affected·Aug 15, 2014
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. ...
Medical Devices·1,147 affected·Aug 15, 2014
High RiskFDA
Biomedix, Inc.
Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging includes 48 pouched...
Medical Devices·2,928 affected·Aug 14, 2014
High RiskFDA
The Anspach Effort, Inc.
Synthes Small Electric Drive (SED). For use in general traumatology.
Medical Devices·599 affected·Aug 14, 2014
CriticalFDA
Biofire Defense
JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable...
Medical Devices·43 affected·Aug 13, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc.
V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiol...
Medical Devices·321 affected·Aug 13, 2014
High RiskFDA
Vapotherm, Inc.
Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ Sy...
Medical Devices·207 affected·Aug 13, 2014
High RiskFDA
Smith & Nephew, Inc.
RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as...
Medical Devices·2,142 affected·Aug 13, 2014
High RiskFDA
Gendex Corp
eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW...
Medical Devices·651 affected·Aug 12, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc.
The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagn...
Medical Devices·877 affected·Aug 12, 2014
CriticalFDA
Ethicon Endo-surgery Inc
PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bu...
Medical Devices·42,798 affected·Aug 12, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc.
The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagn...
Medical Devices·1,330 affected·Aug 12, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Br...
Medical Devices·216,240 affected·Aug 8, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Br...
Medical Devices·216,240 affected·Aug 8, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Medical Devices·0 affected·Aug 8, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Br...
Medical Devices·216,240 affected·Aug 8, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Br...
Medical Devices·216,240 affected·Aug 8, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Br...
Medical Devices·216,240 affected·Aug 8, 2014
High RiskFDA
Zimmer, Inc.
PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12...
Medical Devices·77,737 affected·Aug 7, 2014
High RiskFDA
Zimmer, Inc.
PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top;...
Medical Devices·77,737 affected·Aug 7, 2014
High RiskFDA
Angiodynamics, Inc.
Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STER...
Medical Devices·70 affected·Aug 6, 2014
High RiskFDA
Angiodynamics, Inc.
Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STER...
Medical Devices·36 affected·Aug 6, 2014
High RiskFDA
Arrow International Inc
Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
Medical Devices·71,255 affected·Aug 6, 2014
High RiskFDA
Catheter Connections, Inc.
DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap ...
Medical Devices·24,910 affected·Aug 5, 2014
High RiskFDA
Icu Medical, Inc.
Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes are co-packaged into a kit with ICU devices and ...
Medical Devices·300 affected·Aug 5, 2014
High RiskFDA
Icu Medical, Inc.
Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and...
Medical Devices·400 affected·Aug 5, 2014
High RiskFDA
Medical Components, Inc Dba Medcomp
Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in attaining long term vascular access for ...
Medical Devices·110 affected·Aug 4, 2014