Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,708 total recalls
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3
GE Healthcare, LLC
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Mode
MEDLINE INDUSTRIES, LP - Northfield
BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 1
CareFusion 303, Inc.
REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
Becton Dickinson Infusion Therapy Systems, Inc.
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Vortex Surgical Inc.
SmartPath to dStream for 1.5T¿; Product Number: 782146;
Philips North America
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190
Cardinal Health 200, LLC
HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F
American Contract Systems Inc
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
CooperSurgical, Inc.
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultan
Philips North America Llc
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Numbe
Encore Medical, LP
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD2-6S
Carefusion 2200 Inc
Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
Coloplast Manufacturing US, LLC
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:
Zimmer, Inc.
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
Wright Medical Technology, Inc.
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Boston Scientific Corporation
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
Philips North America Llc
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
Baxter Healthcare Corporation
Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)
Stryker Medical Division of Stryker Corporation
Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with co
Mindray DS USA, Inc. dba Mindray North America
Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
Remel Inc
Atellica CI Analyzer. Catalog Numbers: 10947347.
Siemens Healthcare Diagnostics, Inc.
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software
Shanghai United Imaging Healthcare Co., Ltd.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade
Biomet, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001774;
Beaver Visitec International, Inc.
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubin
ICU Medical Inc.
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular
Medtronic Perfusion Systems
Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
K2M, Inc
SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical strips are indicated for the u
Integra LifeSciences Corp.
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609
Howmedica Osteonics Corp.
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