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
Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works...
Medical Devices·20,385 affected·Nov 4, 2013
High RiskFDA
Salter Labs
Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamo...
Medical Devices·91 affected·Nov 1, 2013
CriticalFDA
Hospira Inc.
Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral f...
Medical Devices·13,218 affected·Oct 31, 2013
CriticalFDA
Hospira Inc.
Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and ...
Medical Devices·13,218 affected·Oct 31, 2013
High RiskFDA
Ergosafe Products Llc Dba Prism Medical Services Usa
Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. The responsible firm name listed in the Operations Manual i...
Medical Devices·97 affected·Oct 30, 2013
High RiskFDA
Ergosafe Products Llc Dba Prism Medical Services Usa
Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. The responsible firm name listed in the Operations ...
Medical Devices·233 affected·Oct 30, 2013
High RiskFDA
Synovis Surgical Innovations, Inc.
Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in peripheral vascular reconstruction. Product Code: VG0106...
Medical Devices·6,014 affected·Oct 28, 2013
High RiskFDA
Centurion Medical Products Corporation
Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause allergic reaction...
Medical Devices·500 affected·Oct 28, 2013
CriticalFDA
Nephros Inc
Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water...
Medical Devices·3,367 affected·Oct 28, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc.
e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.
Medical Devices·4,862 affected·Oct 28, 2013
CriticalFDA
Nephros Inc
Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters ...
Medical Devices·3,742 affected·Oct 28, 2013
High RiskFDA
Integra Lifesciences Corp. D.b.a. Integra Pain Management
Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which c...
Medical Devices·359,250 affected·Oct 28, 2013
High RiskFDA
Synovis Surgical Innovations, Inc.
Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the closure of dura mater during neurosurgery. ...
Medical Devices·446 affected·Oct 28, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution o...
Medical Devices·562 affected·Oct 28, 2013
High RiskFDA
Civco Medical Instruments Inc
Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box. Product Usage: This d...
Medical Devices·138 affected·Oct 25, 2013
High RiskFDA
Civco Medical Instruments Inc
Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box. Product Usage: Thi...
Medical Devices·2 affected·Oct 25, 2013
High RiskFDA
Hospira Inc.
*** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron F...
Medical Devices·1 affected·Oct 25, 2013
High RiskFDA
Biomet, Inc.
REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Desig...
Medical Devices·1,130 affected·Oct 25, 2013
High RiskFDA
Stryker Howmedica Osteonics Corp.
1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corpo...
Medical Devices·20 affected·Oct 25, 2013
High RiskFDA
Varian Medical Systems, Inc.
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7...
Medical Devices·3,809 affected·Oct 24, 2013
High RiskFDA
Kimberly-clark Corporation
Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is...
Medical Devices·389,300 affected·Oct 24, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD ...
Medical Devices·30 affected·Oct 23, 2013
High RiskFDA
Raysearch Laboratories Ab
Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Medical Devices·195 affected·Oct 23, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination ...
Medical Devices·26 affected·Oct 23, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD ...
Medical Devices·70 affected·Oct 23, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for venous drainage during cardiopulmonary bypass...
Medical Devices·40 affected·Oct 23, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD wi...
Medical Devices·90 affected·Oct 23, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combinat...
Medical Devices·3 affected·Oct 23, 2013
High RiskFDA
Advanced Sterilization Products
Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.
Medical Devices·2,106 affected·Oct 18, 2013
High RiskFDA
Steris Corporation
AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, &#...
Medical Devices·936 affected·Oct 18, 2013
High RiskFDA
Intra Pump Infusion Systems
CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
Medical Devices·25,440 affected·Oct 18, 2013
High RiskFDA
Baxter Healthcare Corp
15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
Medical Devices·3,085,080 affected·Oct 17, 2013
High RiskFDA
Zimmer, Inc.
Trabecular Metal" Reverse Shoulder System
Medical Devices·73,002 affected·Oct 17, 2013
High RiskFDA
Spacelabs Healthcare, Llc
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube...
Medical Devices·54 affected·Oct 17, 2013
CriticalFDA
Cutera, Inc.
Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distribute...
Medical Devices·451 affected·Oct 16, 2013
High RiskFDA
Baxter Healthcare Corp.
The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Personal Cycler peritoneal dialysis system...
Medical Devices·75 affected·Oct 16, 2013
High RiskFDA
Teleflex Medical
Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube.
Medical Devices·6,200 affected·Oct 15, 2013
High RiskFDA
Synthes (usa) Products Llc
Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part o...
Medical Devices·55 affected·Oct 14, 2013
High RiskFDA
Philips Healthcare Informatics, Inc.
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardwa...
Medical Devices·71 affected·Oct 14, 2013
High RiskFDA
Restoration Robotics
Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tensioner is app...
Medical Devices·515 affected·Oct 13, 2013
High RiskFDA
Restoration Robotics
ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; Dissection Punch 4.0mm FP-23304; Saline ...
Medical Devices·515 affected·Oct 13, 2013
High RiskFDA
Restoration Robotics
ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; dissection Punch 4.0mm ...
Medical Devices·515 affected·Oct 13, 2013
High RiskFDA
Zimmer, Inc.
2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA 2.7 X 9 CORT SCREW/SELFTA 2.7 X 10 CORT SCREW/SELFT 2....
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2....
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
PRESSFIT FEM ST FX 16 X 1
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SELFT 3.5 X 16 CORT SCREW SELFT 3.5 X 18 CORT SCREW SELFT 3....
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
CPT 12/14 COCR (various sizes)
Medical Devices·7,044,680 affected·Oct 11, 2013