Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Zimmer, Inc.
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE E, LEFT TIBIA SIZE E RIGH...
Medical Devices·591 affected·Nov 14, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
220/240V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours o...
Medical Devices·1,647 affected·Nov 14, 2012
High RiskFDA
Zimmer, Inc.
Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile This device is indicated for patients wit...
Medical Devices·135 affected·Nov 14, 2012
High RiskFDA
Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size D Left; Size D Right This device is used with...
Medical Devices·189 affected·Nov 14, 2012
High RiskFDA
Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C Left; Size C Right This device is used with...
Medical Devices·189 affected·Nov 14, 2012
High RiskFDA
Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, Nonsterile, This device is used with the Persona Knee Sy...
Medical Devices·92 affected·Nov 14, 2012
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
Medical Devices·1 affected·Nov 14, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours o...
Medical Devices·1,647 affected·Nov 14, 2012
High RiskFDA
Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile, This device is used with the Persona Knee Sy...
Medical Devices·92 affected·Nov 14, 2012
High RiskFDA
Zimmer, Inc.
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE F, LEFT TIBIA SIZE F RIGH...
Medical Devices·429 affected·Nov 14, 2012
CriticalFDA
Zimmer, Inc.
Zimmer Spine Ardis Inserter, Rx, non-sterile
Medical Devices·315 affected·Nov 12, 2012
High RiskFDA
Biomotion Medical Systems, Llc
SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch C...
Medical Devices·28 affected·Nov 12, 2012
High RiskFDA
Biomet, Inc.
EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modula...
Medical Devices·49 affected·Nov 9, 2012
High RiskFDA
Moog Medical Devices Group
EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with dispos...
Medical Devices·8,736 affected·Nov 8, 2012
High RiskFDA
Medline Industries Inc
Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the...
Medical Devices·105 affected·Nov 8, 2012
High RiskFDA
Invacare Corporation
Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged six (6) canes per shipping ...
Medical Devices·38,280 affected·Nov 6, 2012
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The ...
Medical Devices·12,250 affected·Nov 6, 2012
High RiskFDA
Ethicon Endo-surgery Inc
Ethicon Endo-Surgery Inc. The ENSEAL¿ G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during...
Medical Devices·58,338 affected·Nov 6, 2012
High RiskFDA
Varian Medical Systems, Inc. Oncology Systems
Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, ...
Medical Devices·264 affected·Nov 5, 2012
High RiskFDA
Ansell Healthcare Products Llc
Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, an...
Medical Devices·445 affected·Nov 5, 2012
High RiskFDA
Integra Lifesciences Corporation
MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open ...
Medical Devices·8 affected·Nov 5, 2012
High RiskFDA
Exactech, Inc.
Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are i...
Medical Devices·26 affected·Nov 5, 2012
High RiskFDA
Arobella Medical, Llc
Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy...
Medical Devices·99 affected·Nov 5, 2012
High RiskFDA
Exactech, Inc.
Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Syste...
Medical Devices·26 affected·Nov 5, 2012
High RiskFDA
King Systems Corp.
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient ...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
King Systems Corp.
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient ...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
King Systems Corp.
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Produ...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
King Systems Corp.
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD¿ Patient Size: >70k...
Medical Devices·263 affected·Nov 2, 2012
CriticalFDA
Brookstone Company, Inc.
Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue), 734864 (Plum), 734865 (Red). Brookstone 3 in 1 wrap ,SKU7...
Medical Devices·109,956 affected·Nov 2, 2012
High RiskFDA
King Systems Corp.
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50k...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
King Systems Corp.
KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Pro...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
King Systems Corp.
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Pr...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
Maquet Inc.
Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt,Germany Used to support...
Medical Devices·63 affected·Nov 2, 2012
High RiskFDA
Biomet, Inc.
OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to...
Medical Devices·36 affected·Nov 1, 2012
High RiskFDA
B Braun Medical, Inc.
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary f...
Medical Devices·1,970 affected·Oct 31, 2012
High RiskFDA
Hill-rom, Inc.
Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall, Multirall and Masterlift System...
Medical Devices·3,816 affected·Oct 31, 2012
High RiskFDA
J T Posey Company
Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for ...
Medical Devices·1,673 affected·Oct 31, 2012
High RiskFDA
Orthohelix Surgical Designs Inc
Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.
Medical Devices·2,399,041 affected·Oct 30, 2012
High RiskFDA
Hospira Inc.
Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides w...
Medical Devices·0 affected·Oct 26, 2012
High RiskFDA
Hospira Inc.
Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethern...
Medical Devices·0 affected·Oct 26, 2012
High RiskFDA
Quasar Bio-tech, Inc. Dba Silver Bay Llc
Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby Blue uses blue LED light to b...
Medical Devices·7,734 affected·Oct 25, 2012
High RiskFDA
Quasar Bio-tech, Inc. Dba Silver Bay Llc
Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASA...
Medical Devices·7,734 affected·Oct 25, 2012
High RiskFDA
Stryker Howmedica Osteonics Corp.
Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
Medical Devices·476 affected·Oct 25, 2012
High RiskFDA
Quasar Bio-tech, Inc. Dba Silver Bay Llc
Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD ...
Medical Devices·7,734 affected·Oct 25, 2012
CriticalFDA
Verathon, Inc.
The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a ...
Medical Devices·2,710 affected·Oct 25, 2012
High RiskFDA
Carl Zeiss Meditec, Inc.
INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation ther...
Medical Devices·36 affected·Oct 25, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. For use when hemostasis is desired along suture lines, ...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For use when hemostasis is desired along suture lines...
Medical Devices·26,422 affected·Oct 24, 2012