Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Ge Healthcare, Llc
Legacy
Medical Devices·1,598 affected·Nov 21, 2016
High RiskFDA
Oculus Innovative Sciences, Inc.
Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the supervision of a health care profe...
Medical Devices·68,970 affected·Nov 21, 2016
CriticalFDA
Ohmeda Medical
Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy System provides light therapy for the tre...
Medical Devices·5,993 affected·Nov 18, 2016
CriticalFDA
Ohmeda Medical
Giraffe Incubator The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unabl...
Medical Devices·5,993 affected·Nov 18, 2016
CriticalFDA
Ohmeda Medical
Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incubator ) and an infant radiant warmer (...
Medical Devices·5,993 affected·Nov 18, 2016
High RiskFDA
Ultradent Products, Inc.
UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for p...
Medical Devices·31 affected·Nov 17, 2016
High RiskFDA
Carefusion 303, Inc.
SmartSite Add-On Bag Access Device, Model No. 10013365
Medical Devices·384,923 affected·Nov 17, 2016
High RiskFDA
Elekta, Inc.
Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Medical Devices·2,148 affected·Nov 17, 2016
High RiskFDA
Smith & Nephew, Inc.
REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Medical Devices·4,444 affected·Nov 16, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstru...
Medical Devices·104 affected·Nov 15, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to pro...
Medical Devices·20 affected·Nov 14, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 728231 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction...
Medical Devices·184 affected·Nov 12, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstructio...
Medical Devices·337 affected·Nov 12, 2016
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only. Intended for patients who would benef...
Medical Devices·15,960 affected·Nov 11, 2016
High RiskFDA
Greatbatch Medical
ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
Medical Devices·5,000 affected·Nov 11, 2016
High RiskFDA
Halyard Health
Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.
Medical Devices·59 affected·Nov 10, 2016
High RiskFDA
Raysearch Laboratories Ab
RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed...
Medical Devices·66 affected·Nov 9, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
Medical Devices·2,090 affected·Nov 9, 2016
High RiskFDA
Teleflex Medical
ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow ...
Medical Devices·113,647 affected·Nov 8, 2016
High RiskFDA
Wright Medical Technology, Inc.
PRO-STIM 10cc INJECTABLE, Part Number 86SR0410
Medical Devices·19 affected·Nov 8, 2016
High RiskFDA
Depuy Orthopaedics, Inc.
LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
Medical Devices·1 affected·Nov 8, 2016
High RiskFDA
Teleflex Medical
ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone bio...
Medical Devices·0 affected·Nov 8, 2016
High RiskFDA
Wright Medical Technology, Inc.
Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514
Medical Devices·66 affected·Nov 8, 2016
High RiskFDA
Wright Medical Technology, Inc.
SWANSON FINGER JOINT #1, Part Number 4700001
Medical Devices·20 affected·Nov 8, 2016
High RiskFDA
Wright Medical Technology, Inc.
INBONE STEM, TIBIAL, TOP, Part Number 200011901
Medical Devices·65 affected·Nov 8, 2016
High RiskFDA
Teleflex Medical
OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marr...
Medical Devices·0 affected·Nov 8, 2016
High RiskFDA
Wright Medical Technology, Inc.
CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001
Medical Devices·42 affected·Nov 8, 2016
High RiskFDA
Wright Medical Technology, Inc.
EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010
Medical Devices·30 affected·Nov 8, 2016
High RiskFDA
Meridian Bioscience Inc
PREMIER EHEC and PREMIER EHEC Bulk.
Medical Devices·4,747 affected·Nov 8, 2016
High RiskFDA
Wright Medical Technology, Inc.
SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104
Medical Devices·30 affected·Nov 8, 2016
High RiskFDA
Deroyal Industries Inc
TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
Medical Devices·56 affected·Nov 7, 2016
High RiskFDA
Becton Dickinson & Company
BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anes...
Medical Devices·4,500 affected·Nov 7, 2016
High RiskFDA
Exactech, Inc.
AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.
Medical Devices·12 affected·Nov 7, 2016
High RiskFDA
Exactech, Inc.
Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6
Medical Devices·98 affected·Nov 7, 2016
High RiskFDA
Deroyal Industries Inc
PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
Medical Devices·791 affected·Nov 7, 2016
High RiskFDA
Thayer Intellectual Property, Inc.
MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in pati...
Medical Devices·339 affected·Nov 4, 2016
High RiskFDA
Terumo Bct, Inc.
Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
Medical Devices·660 affected·Nov 3, 2016
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Avance, Avance CS2, Amingo.
Medical Devices·23,098 affected·Nov 3, 2016
High RiskFDA
Elekta, Inc.
Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Medical Devices·671 affected·Nov 3, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to ...
Medical Devices·7 affected·Nov 2, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to p...
Medical Devices·7 affected·Nov 2, 2016
High RiskFDA
Synthes (usa) Products Llc
Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
Medical Devices·84 affected·Nov 1, 2016
High RiskFDA
Carefusion 303, Inc.
Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion p...
Medical Devices·613,800 affected·Nov 1, 2016
High RiskFDA
Mevion Medical Systems, Inc.
MEVION S250 Product Usage: Proton Radiation Therapy
Medical Devices·6 affected·Oct 31, 2016
High RiskFDA
Spectranetics Corporation
Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative oc...
Medical Devices·873 affected·Oct 31, 2016
RecallFDA
Smiths Medical Asd, Inc.
HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood a...
Medical Devices·33 affected·Oct 31, 2016
High RiskFDA
Owens & Minor Distribution, Inc.
Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 1...
Medical Devices·568 affected·Oct 31, 2016
High RiskFDA
Natus Medical Incorporated
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 00622...
Medical Devices·2,619 affected·Oct 28, 2016