Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Zimmer Biomet, Inc.
CR-FLEX GSF PCT SZ C-R MINUS¿ CR-FLEX GSF PCT SZ D-L MINUS¿ CR-FLEX GSF PCT SZ D-R MINUS¿ CR-FLEX GSF PCT SZ E-L MINUS¿ CR-FLEX GSF P...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device is indicated for patients with severe knee pain and di...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chond...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
CR-FLEX PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS CR-FLEX PCT FEM D-R MINUS CR-FLEX PCT FEM E-L MINUS CR-FLEX PCT FEM E-R MINUS CR...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
LPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS OPTION FEMORAL D-R LPS OPTION FEMORAL E-L LPS OPTION FEMORA...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated for patients with severe knee pain and disability
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Spineart Sa
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervic...
Medical Devices·120 affected·Nov 27, 2017
High RiskFDA
Spineart Sa
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervic...
Medical Devices·15 affected·Nov 27, 2017
High RiskFDA
Spineart Sa
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervic...
Medical Devices·54 affected·Nov 27, 2017
High RiskFDA
Spineart Sa
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervic...
Medical Devices·8 affected·Nov 27, 2017
High RiskFDA
Spineart Sa
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervi...
Medical Devices·9 affected·Nov 27, 2017
High RiskFDA
Smiths Medical Asd Inc.
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
Medical Devices·58 affected·Nov 22, 2017
High RiskFDA
Santa Joy Ornament & Giftware Co
Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various c...
Medical Devices·433,128 affected·Nov 21, 2017
High RiskFDA
Raysearch Laboratories Ab
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (Ray...
Medical Devices·744 affected·Nov 20, 2017
High RiskFDA
Zimmer Dental Inc
Tapered Screw-Vent MTX Model TSVTB11
Medical Devices·500 affected·Nov 20, 2017
High RiskFDA
Elekta Limited
Integrity R1.2
Medical Devices·539 affected·Nov 20, 2017
High RiskFDA
Elekta Limited
Agility with Integrity R3.2
Medical Devices·539 affected·Nov 20, 2017
High RiskFDA
Stryker Corporation
STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
Medical Devices·60,753 affected·Nov 17, 2017
High RiskFDA
Philips Electronics North America Corporation
IntelliVue X3 Patient Monitor.
Medical Devices·975 affected·Nov 17, 2017
High RiskFDA
Carefusion 303, Inc.
Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infus...
Medical Devices·73,611 affected·Nov 17, 2017
High RiskFDA
Perkinelmer Life And Analytical Sciences, Wallac, Oy
Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate ...
Medical Devices·8 affected·Nov 17, 2017
High RiskFDA
Accuray Incorporated
TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated syste...
Medical Devices·87 affected·Nov 17, 2017
High RiskFDA
Stryker Corporation
STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600);...
Medical Devices·60,753 affected·Nov 17, 2017
High RiskFDA
Accuray Incorporated
TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system ...
Medical Devices·29 affected·Nov 17, 2017
High RiskFDA
Accuray Incorporated
TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system...
Medical Devices·118 affected·Nov 17, 2017
High RiskFDA
Brainlab Ag
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
Medical Devices·80 affected·Nov 16, 2017
High RiskFDA
Medacta Usa Inc
Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or re...
Medical Devices·837 affected·Nov 15, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the central circulation.
Medical Devices·18,124 affected·Nov 14, 2017
High RiskFDA
Carl Zeiss Metrology Inc
Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
Medical Devices·13 affected·Nov 14, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fl...
Medical Devices·16,600 affected·Nov 13, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fl...
Medical Devices·16,600 affected·Nov 13, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fl...
Medical Devices·16,600 affected·Nov 13, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission dat...
Medical Devices·3 affected·Nov 10, 2017
High RiskFDA
C.r. Bard, Inc.
CritiCore Automated Urine Output and Temperature Monitor
Medical Devices·0 affected·Nov 10, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at differen...
Medical Devices·13 affected·Nov 10, 2017
High RiskFDA
Zevex Incorporated (dba Moog Medical Medical Devices Group)
MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Needleless Injection Port ...
Medical Devices·756 affected·Nov 10, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core, (Code 728321) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data ta...
Medical Devices·1 affected·Nov 10, 2017
High RiskFDA
Wiener Laboratories
Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
Medical Devices·1,563 affected·Nov 10, 2017
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Medical Devices·1,243,400 affected·Nov 10, 2017
High RiskFDA
Zevex Incorporated (dba Moog Medical Medical Devices Group)
MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, p...
Medical Devices·2,497 affected·Nov 10, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.
Medical Devices·732 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
Medical Devices·320 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.
Medical Devices·12 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
Medical Devices·900 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.
Medical Devices·51 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-...
Medical Devices·504 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 ...
Medical Devices·1,542 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurize...
Medical Devices·444 affected·Nov 9, 2017