Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Cook Inc.
Amplatz Extra Stiff Whisker Wire Guide
Medical Devices·648 affected·Oct 13, 2017
High RiskFDA
Cook Inc.
Fixed Core Wire Guide
Medical Devices·601,778 affected·Oct 13, 2017
High RiskFDA
Cook Inc.
Bentson Plus Wire Guide
Medical Devices·8,147 affected·Oct 13, 2017
High RiskFDA
Cook Inc.
Disposable Reuter Tip Deflecting Wire Guide
Medical Devices·18,398 affected·Oct 13, 2017
High RiskFDA
Covidien Llc
Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton disposable that ...
Medical Devices·20,800 affected·Oct 12, 2017
High RiskFDA
Zimmer Biomet, Inc.
TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel...
Medical Devices·0 affected·Oct 11, 2017
High RiskFDA
Ortho Solutions, Ltd.
SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; ...
Medical Devices·120 affected·Oct 10, 2017
High RiskFDA
Karl Storz Endoscopy
STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on out...
Medical Devices·496 affected·Oct 10, 2017
High RiskFDA
Crimson Trace Corporation
Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used for personal defense and t...
Medical Devices·184,390 affected·Oct 10, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Brilliance 64 computed tomography x-ray system
Medical Devices·1,801 affected·Oct 6, 2017
High RiskFDA
Halyard Health, Inc
Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
Medical Devices·52,660 affected·Oct 6, 2017
High RiskFDA
Halyard Health, Inc
Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
Medical Devices·52,660 affected·Oct 6, 2017
High RiskFDA
Halyard Health, Inc
Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case.
Medical Devices·52,660 affected·Oct 6, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Ingenuity Core computed tomography x-ray system
Medical Devices·0 affected·Oct 6, 2017
High RiskFDA
Halyard Health, Inc
Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 vials per kit, 20 kits per case.
Medical Devices·52,660 affected·Oct 6, 2017
High RiskFDA
Halyard Health, Inc
Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet Pak. 12 vials per kit, 20 kits per case.
Medical Devices·52,660 affected·Oct 6, 2017
High RiskFDA
Halyard Health, Inc
NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double Swivel Elbow, 14 F. 6 vials per kit, 2...
Medical Devices·52,660 affected·Oct 6, 2017
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. ...
Medical Devices·173,375 affected·Oct 6, 2017
High RiskFDA
Teleflex Medical
WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO
Medical Devices·13,710 affected·Oct 5, 2017
High RiskFDA
Ge Healthcare, Llc
DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
Medical Devices·2 affected·Oct 4, 2017
High RiskFDA
Boston Scientific Corporation
RESONATE X4 CRT-D, Model G447, Sterile.
Medical Devices·11 affected·Oct 4, 2017
High RiskFDA
Boston Scientific Corporation
RESONATE EL ICD VR, Model D432, Sterile.
Medical Devices·5 affected·Oct 4, 2017
High RiskFDA
Boston Scientific Corporation
MOMENTUM X4 CRT-D, Model G138, Sterile.
Medical Devices·4 affected·Oct 4, 2017
High RiskFDA
Boston Scientific Corporation
RESONATE EL ICD DR, Model D433, Sterile.
Medical Devices·12 affected·Oct 4, 2017
High RiskFDA
Ge Healthcare, Llc
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in cont...
Medical Devices·28 affected·Oct 4, 2017
High RiskFDA
Draegar Medical Systems, Inc.
INFINITY DUAL HEMO MCable Pod
Medical Devices·2,760 affected·Oct 4, 2017
High RiskFDA
Vygon Mfg, Inc., Dba/ Churchill Medical Systems, Inc.
Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
Medical Devices·21,350 affected·Oct 3, 2017
High RiskFDA
Arthrex, Inc.
iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, ...
Medical Devices·20 affected·Oct 3, 2017
High RiskFDA
Zimmer Biomet, Inc.
Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty
Medical Devices·8 affected·Oct 3, 2017
High RiskFDA
Zimmer Biomet, Inc.
Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040
Medical Devices·127 affected·Oct 3, 2017
High RiskFDA
Zimmer Biomet, Inc.
Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: ...
Medical Devices·457 affected·Oct 3, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cro...
Medical Devices·6 affected·Oct 2, 2017
High RiskFDA
Abbott Laboratories, Inc
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
Medical Devices·34 affected·Sep 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee a...
Medical Devices·24 affected·Sep 29, 2017
High RiskFDA
C.r. Bard, Inc.
BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor ...
Medical Devices·2 affected·Sep 29, 2017
High RiskFDA
Cosmedent, Inc.
Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
Medical Devices·84 affected·Sep 28, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 478...
Medical Devices·1,557 affected·Sep 28, 2017
High RiskFDA
The Magstim Company Limited
Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Mai...
Medical Devices·43 affected·Sep 28, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
Medical Devices·510 affected·Sep 28, 2017
High RiskFDA
Mobius Imaging, Llc
AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be used for X-ray computed tomography applicat...
Medical Devices·105 affected·Sep 26, 2017
RecallFDA
Perkinelmer Life And Analytical Sciences, Wallac, Oy
AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(o...
Medical Devices·240 affected·Sep 25, 2017
High RiskFDA
Smiths Medical Asd Inc.
CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (exc...
Medical Devices·11,170,535 affected·Sep 25, 2017
High RiskFDA
Circulatory Technology Inc
**Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, ...
Medical Devices·410 affected·Sep 22, 2017
High RiskFDA
Aesculap Implant Systems Llc
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
Medical Devices·2 affected·Sep 21, 2017
RecallFDA
Philips Electronics North America Corporation
Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.
Medical Devices·1,079 affected·Sep 20, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX. .
Medical Devices·643 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .
Medical Devices·537 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX.
Medical Devices·953 affected·Sep 19, 2017