Category

Medical Devices Recalls

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

15,654 recalls
CriticalFDA
Pro-med Instruments Gmbh
DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
Medical Devices·31 affected·Jul 5, 2018
High RiskFDA
Radiometer America Inc
ABL800 analyzer, model numbers 393-800 and 393-801.
Medical Devices·2,131 affected·Jul 3, 2018
RecallFDA
Alden Optical
Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenle...
Medical Devices·36 affected·Jul 3, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by ...
Medical Devices·23 affected·Jul 3, 2018
High RiskFDA
Hudson Scientific Llc
iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the soft...
Medical Devices·35,949 affected·Jul 2, 2018
High RiskFDA
Cypress Medical Products Llc
Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam glove for use by professional healthcare workers ...
Medical Devices·66 affected·Jul 2, 2018
High RiskFDA
Back 2 Basics Direct Llc
Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to prov...
Medical Devices·10 affected·Jun 29, 2018
High RiskFDA
Quasar Bio-tech, Inc.
Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
Medical Devices·6,783 affected·Jun 29, 2018
High RiskFDA
Mevion Medical Systems, Inc.
MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatm...
Medical Devices·7 affected·Jun 29, 2018
High RiskFDA
Raysearch Laboratories Ab
RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, Ray...
Medical Devices·746 affected·Jun 29, 2018
High RiskFDA
Bayer Medical Care, Inc.
Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. ...
Medical Devices·1 affected·Jun 28, 2018
High RiskFDA
Biomerieux, Inc.
BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an aut...
Medical Devices·151 affected·Jun 27, 2018
High RiskFDA
Elekta Instrument Ab
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Medical Devices·52 affected·Jun 27, 2018
High RiskFDA
Genicon, Inc.
Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use o...
Medical Devices·1,550 affected·Jun 27, 2018
High RiskFDA
Biomerieux, Inc.
BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is ...
Medical Devices·8 affected·Jun 27, 2018
High RiskFDA
Leica Microsystems, Inc.
Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
Medical Devices·123 affected·Jun 25, 2018
High RiskFDA
Carl Zeiss Meditec Ag
Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
Medical Devices·1 affected·Jun 25, 2018
High RiskFDA
Smiths Medical Asd Inc.
Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Ele...
Medical Devices·28,578,939 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure P...
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Smiths Medical Asd Inc.
Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-...
Medical Devices·28,578,939 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Ossur Americas
Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK; 516V2S/ Skull Pin 3in TI Sterl 1PK;...
Medical Devices·372 affected·Jun 21, 2018
High RiskFDA
Ossur Americas
Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel; 545700L/ ReSolve Halo Vest-shrt lmbwool; 54580...
Medical Devices·381 affected·Jun 21, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectru...
Medical Devices·158 affected·Jun 21, 2018
High RiskFDA
Ossur Americas
Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT SML; 505400C/ CB RESOLVE STERILE UNIT STD; 505500C/...
Medical Devices·656 affected·Jun 21, 2018
High RiskFDA
Ossur Americas
Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML; 505400D/ OB RESOLVE RING KIT STD; 505500D/ OB ...
Medical Devices·342 affected·Jun 21, 2018
High RiskFDA
Ossur Americas
Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in CT Sterl 1PK; 516DS/ Skull Pin 3in CT Sterl 1...
Medical Devices·824 affected·Jun 21, 2018
High RiskFDA
Depuy Orthopaedics, Inc.
CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
Medical Devices·0 affected·Jun 21, 2018
High RiskFDA
Becton Dickinson & Co.
BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisseria gonorrhoeae...
Medical Devices·10,360 affected·Jun 21, 2018
High RiskFDA
Ossur Americas
Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML...
Medical Devices·138 affected·Jun 21, 2018
High RiskFDA
Nico Corp.
NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
Medical Devices·204 affected·Jun 19, 2018
High RiskFDA
Lemaitre Vascular, Inc.
AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an ana...
Medical Devices·0 affected·Jun 19, 2018
High RiskFDA
Hitachi Medical Systems America Inc
Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician with physiolo...
Medical Devices·264 affected·Jun 18, 2018
High RiskFDA
Covidien Llc
Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
Medical Devices·972 affected·Jun 15, 2018
RecallFDA
Nidek Inc.
RT-5100 Refractor, a component of the Epic-5100 System.
Medical Devices·85 affected·Jun 14, 2018
High RiskFDA
Abbott Laboratories, Inc.
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics Syst...
Medical Devices·2,521 affected·Jun 14, 2018
High RiskFDA
Beekley Corporation
S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.
Medical Devices·3,384,024 affected·Jun 13, 2018