Category

Medical Devices Recalls

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

15,654 recalls
RecallFDA
Lab Vision Corporation
Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip1/Sdi1/Pic1 i...
Medical Devices·5 affected·Oct 27, 2015
High RiskFDA
Arthrocare Corporation
Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal pr...
Medical Devices·262 affected·Oct 26, 2015
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio with software version 10.1 LA.
Medical Devices·1 affected·Oct 26, 2015
CriticalFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.
Medical Devices·348 affected·Oct 23, 2015
CriticalFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemo...
Medical Devices·992 affected·Oct 23, 2015
CriticalFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.
Medical Devices·918 affected·Oct 23, 2015
High RiskFDA
Innokas Medical Oy
CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans
Medical Devices·424 affected·Oct 22, 2015
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone ...
Medical Devices·9 affected·Oct 20, 2015
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone f...
Medical Devices·9 affected·Oct 20, 2015
High RiskFDA
Synthes (usa) Products Llc
Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum follo...
Medical Devices·267 affected·Oct 19, 2015
High RiskFDA
Invivo Corporation
The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intrane...
Medical Devices·2,929 affected·Oct 19, 2015
High RiskFDA
Elekta, Inc.
Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Medical Devices·154 affected·Oct 16, 2015
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip a...
Medical Devices·1 affected·Oct 15, 2015
High RiskFDA
Merge Healthcare, Inc.
DR Systems Unity PACS software, now known as Merge Unity PACS software.
Medical Devices·9 affected·Oct 15, 2015
High RiskFDA
Teleflex Medical
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
Medical Devices·2,050 affected·Oct 14, 2015
High RiskFDA
Ceterix Orthopedics, Inc.
NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
Medical Devices·1,364 affected·Oct 13, 2015
CriticalFDA
Boston Scientific Corporation
RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H80...
Medical Devices·955 affected·Oct 9, 2015
CriticalFDA
Boston Scientific Corporation
RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), ...
Medical Devices·955 affected·Oct 9, 2015
CriticalFDA
Miramar Labs, Inc.
miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. ...
Medical Devices·277 affected·Oct 9, 2015
High RiskFDA
Cyberonics, Inc
Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
Medical Devices·27 affected·Oct 7, 2015
High RiskFDA
Ivoclar A. G.
Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoc...
Medical Devices·337 affected·Oct 7, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine,...
Medical Devices·87 affected·Oct 7, 2015
High RiskFDA
Hill-rom, Inc.
Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed
Medical Devices·12,251 affected·Oct 7, 2015
High RiskFDA
Baxter Healthcare Corp.
Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
Medical Devices·19,440 affected·Oct 6, 2015
High RiskFDA
Synthes (usa) Products Llc
2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fr...
Medical Devices·98 affected·Oct 6, 2015
High RiskFDA
Avid Medical, Inc.
PEDIATRIC KIDNEY BIOPSY TRAY
Medical Devices·20 affected·Oct 5, 2015
High RiskFDA
Avid Medical, Inc.
Convenience Kits, MOHS "OPENING" PROCEDURE TRAY
Medical Devices·240 affected·Oct 5, 2015
High RiskFDA
Avid Medical, Inc.
Convenience Kits, MOHS "OPENING" PROCEDURE TRAY
Medical Devices·240 affected·Oct 5, 2015
High RiskFDA
Walkmed Infusion, Llc
Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump)....
Medical Devices·4,695 affected·Oct 1, 2015
High RiskFDA
Powers Medical Devices, Llc
The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL ...
Medical Devices·128 affected·Oct 1, 2015
High RiskFDA
Shimadzu Medical Systems
Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.
Medical Devices·26 affected·Sep 30, 2015
High RiskFDA
Biomet Spine, Llc
MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decom...
Medical Devices·17 affected·Sep 29, 2015
High RiskFDA
Ge Healthcare
The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sou...
Medical Devices·6 affected·Sep 28, 2015
High RiskFDA
Varian Medical Systems, Inc.
ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA ...
Medical Devices·1,971 affected·Sep 28, 2015
High RiskFDA
Ge Healthcare
The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imagin...
Medical Devices·5 affected·Sep 28, 2015
High RiskFDA
Stryker Spine
Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide additional support during fusion using autograft or a...
Medical Devices·42 affected·Sep 25, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
Medical Devices·15 affected·Sep 24, 2015
High RiskFDA
Airways Development Llc
Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
Medical Devices·1,464 affected·Sep 24, 2015
High RiskFDA
Ethicon Endo-surgery Inc
HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue ...
Medical Devices·441,490 affected·Sep 23, 2015
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·16 affected·Sep 22, 2015
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive ...
Medical Devices·89 affected·Sep 22, 2015
High RiskFDA
Valeant Pharmacueticals International
Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumat...
Medical Devices·1,178 affected·Sep 21, 2015
High RiskFDA
Stryker Craniomaxillofacial Division
Disposable Paper Filter for Sterilization Containers Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape, Manufactured...
Medical Devices·915 affected·Sep 17, 2015
High RiskFDA
Ge Healthcare
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data fr...
Medical Devices·921 affected·Sep 16, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Medical Devices·108 affected·Sep 14, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Medical Devices·36 affected·Sep 14, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Medical Devices·323 affected·Sep 14, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Medical Devices·268 affected·Sep 14, 2015