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
Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.
Medical Devices·384 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-0...
Medical Devices·1,244 affected·Nov 9, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Healthcare Brilliance iCT computed tomography x-ray system
Medical Devices·702 affected·Nov 8, 2017
High RiskFDA
Med Tec Inc
Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1...
Medical Devices·5 affected·Nov 8, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Healthcare Brilliance iCT SP computed tomography x-ray system
Medical Devices·134 affected·Nov 8, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body ...
Medical Devices·2 affected·Nov 7, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body o...
Medical Devices·2 affected·Nov 7, 2017
High RiskFDA
Owen Mumford Usa, Inc.
Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use p...
Medical Devices·2,660 affected·Nov 6, 2017
High RiskFDA
Owen Mumford Usa, Inc.
Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use p...
Medical Devices·708 affected·Nov 6, 2017
High RiskFDA
Alden Optical
NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for daily wear fo...
Medical Devices·33 affected·Nov 3, 2017
High RiskFDA
Beckman Coulter Inc.
UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
Medical Devices·15 affected·Nov 3, 2017
High RiskFDA
Beckman Coulter Inc.
UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except tha...
Medical Devices·1 affected·Nov 3, 2017
High RiskFDA
Brainlab Ag
BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 T...
Medical Devices·28 affected·Nov 3, 2017
High RiskFDA
Alden Optical
Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 Product Usage: The ALDEN SPHERE LENS for daily wear is indic...
Medical Devices·4 affected·Nov 3, 2017
High RiskFDA
Handicare Usa Inc
Handicare C Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another.
Medical Devices·716 affected·Nov 3, 2017
High RiskFDA
Volcano Corporation
Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 4...
Medical Devices·1,166 affected·Nov 3, 2017
High RiskFDA
Alden Optical
NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for daily wear for ...
Medical Devices·3 affected·Nov 3, 2017
High RiskFDA
Alden Optical
Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for...
Medical Devices·5 affected·Nov 3, 2017
High RiskFDA
Alden Optical
Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for...
Medical Devices·56 affected·Nov 3, 2017
High RiskFDA
Epigenomics Ag
Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer,...
Medical Devices·200 affected·Nov 2, 2017
High RiskFDA
Pro-med Instruments Gmbh
pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY...
Medical Devices·1,142 affected·Nov 2, 2017
High RiskFDA
Ion Beam Applications S.a.
Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Prot...
Medical Devices·3 affected·Nov 1, 2017
High RiskFDA
Sorin Group Deutschland Gmbh
CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Cont...
Medical Devices·1,318 affected·Oct 30, 2017
High RiskFDA
Ge Healthcare, Llc
Discover VH/Millennium VG Nuclear Medicine Imaging System
Medical Devices·339 affected·Oct 30, 2017
High RiskFDA
Icu Medical Inc
ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b) 16037-64-02; MedNet ...
Medical Devices·108 affected·Oct 30, 2017
RecallFDA
Xintec Corp
OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Ste...
Medical Devices·45 affected·Oct 29, 2017
High RiskFDA
Nordicneurolab As
fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the...
Medical Devices·64 affected·Oct 28, 2017
High RiskFDA
L3 Security & Detection
L3 Security & Detection System Cabinet X-ray system used for security screening of checked airline baggage.
Medical Devices·471 affected·Oct 27, 2017
High RiskFDA
Diagnostica Stago, Inc.
STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
Medical Devices·0 affected·Oct 25, 2017
High RiskFDA
Diagnostica Stago, Inc.
Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).
Medical Devices·0 affected·Oct 25, 2017
High RiskFDA
Diagnostica Stago, Inc.
STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
Medical Devices·0 affected·Oct 25, 2017
High RiskFDA
Diagnostica Stago, Inc.
Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
Medical Devices·1,636 affected·Oct 25, 2017
High RiskFDA
Zimmer Biomet, Inc.
A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
Medical Devices·22 affected·Oct 25, 2017
High RiskFDA
Zimmer Biomet, Inc.
fastener, fixation, nondegradable, soft tissue
Medical Devices·429 affected·Oct 25, 2017
High RiskFDA
Medacta Usa Inc
The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.01...
Medical Devices·12,768 affected·Oct 24, 2017
High RiskFDA
Smith & Nephew, Inc.
smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
Medical Devices·17 affected·Oct 24, 2017
High RiskFDA
Medtronic Minimally Invasive Therapies Group
Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of de...
Medical Devices·58,954 affected·Oct 24, 2017
High RiskFDA
Arrow International Inc
Pneumothorax Kit
Medical Devices·0 affected·Oct 24, 2017
High RiskFDA
Arrow International Inc
Large Volume Abdominal Paracentesis Kit
Medical Devices·30,577 affected·Oct 24, 2017
High RiskFDA
Centurion Medical Products Corporation
NEONATAL IV ACCESS SET
Medical Devices·0 affected·Oct 23, 2017
High RiskFDA
Centurion Medical Products Corporation
GENERAL PURPOSE INSTRUMENT TRAY
Medical Devices·0 affected·Oct 23, 2017
High RiskFDA
Centurion Medical Products Corporation
SUTURE REMOVAL TRAY, SET or KIT
Medical Devices·0 affected·Oct 23, 2017
High RiskFDA
Centurion Medical Products Corporation
LATEX FREE IV START SET
Medical Devices·0 affected·Oct 23, 2017
High RiskFDA
Smith & Nephew, Inc.
Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
Medical Devices·9 affected·Oct 23, 2017
High RiskFDA
Centurion Medical Products Corporation
NEONATAL IV START KIT
Medical Devices·0 affected·Oct 23, 2017
High RiskFDA
Centurion Medical Products Corporation
IV START KIT
Medical Devices·0 affected·Oct 23, 2017
High RiskFDA
Centurion Medical Products Corporation
INFANT IV SECUREMENT KIT
Medical Devices·0 affected·Oct 23, 2017
High RiskFDA
Ethicon Endo-surgery Inc
Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-s...
Medical Devices·148 affected·Oct 23, 2017