Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394
Medical Devices·114 affected·Aug 11, 2016
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306
Medical Devices·6,786 affected·Aug 11, 2016
High RiskFDA
Synergetics Inc
25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a ...
Medical Devices·255 affected·Aug 11, 2016
High RiskFDA
Medline Industries Inc
Rigid Suction Canister 3000 CC and 2000 CC.
Medical Devices·7,680 affected·Aug 10, 2016
High RiskFDA
Global Healthcare Inc
MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientifi...
Medical Devices·282 affected·Aug 9, 2016
High RiskFDA
Nidek Inc
SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, hi...
Medical Devices·29 affected·Aug 8, 2016
High RiskFDA
Becton Dickinson & Company
BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in. Tubing Catalog # 367342 Intended for venipuncture to...
Medical Devices·1,788,150 affected·Aug 8, 2016
RecallFDA
Acumedia Manufacturers, Inc.
Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sani...
Medical Devices·10 affected·Aug 8, 2016
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellul...
Medical Devices·5,282 affected·Aug 8, 2016
High RiskFDA
Becton Dickinson & Company
BD Vacutainer Push Button Blood Collection Set, Sterile, Rx only, 0.6 x 19 mm x 305 mm, 23G x 3/4" x 12", REF 367342.
Medical Devices·1,788,150 affected·Aug 8, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, commu...
Medical Devices·338 affected·Aug 5, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc.
e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the body or organ, u...
Medical Devices·5,451 affected·Aug 5, 2016
CriticalFDA
Beckman Coulter Inc.
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions ...
Medical Devices·759 affected·Aug 4, 2016
High RiskFDA
Integra Lifesciences Corp. D.b.a. Integra Pain Management
INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.
Medical Devices·200 affected·Aug 4, 2016
High RiskFDA
Ge Healthcare, Llc
Infant Warmer System (IWS)
Medical Devices·32,073 affected·Aug 4, 2016
High RiskFDA
Lemaitre Vascular, Inc.
1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre Valvulotome is int...
Medical Devices·380 affected·Aug 3, 2016
High RiskFDA
Lemaitre Vascular, Inc.
1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the t...
Medical Devices·1,992 affected·Aug 3, 2016
High RiskFDA
Hologic, Inc
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for...
Medical Devices·535 affected·Aug 2, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archiv...
Medical Devices·101 affected·Aug 2, 2016
High RiskFDA
Hologic, Inc
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for...
Medical Devices·1,440 affected·Aug 2, 2016
High RiskFDA
Randox Laboratories Ltd.
Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in...
Medical Devices·18 affected·Aug 2, 2016
High RiskFDA
Best Sanitizers Inc
Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set ...
Medical Devices·3,023 affected·Aug 2, 2016
RecallFDA
Alere San Diego, Inc.
LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the...
Medical Devices·12,951 affected·Aug 2, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, an...
Medical Devices·37 affected·Aug 1, 2016
High RiskFDA
Aesculap Implant Systems Llc
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
Medical Devices·180 affected·Aug 1, 2016
High RiskFDA
Ethicon, Inc.
ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
Medical Devices·396,024 affected·Aug 1, 2016
High RiskFDA
Zimmer Biomet, Inc.
ROSA BRAIN 3.0.0
Medical Devices·2 affected·Jul 29, 2016
High RiskFDA
B. Braun Medical, Inc.
Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
Medical Devices·15,950 affected·Jul 29, 2016
High RiskFDA
Handicare Ab
Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
Medical Devices·9 affected·Jul 28, 2016
High RiskFDA
Hospira Inc., A Pfizer Company
Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the Sapph...
Medical Devices·20 affected·Jul 28, 2016
High RiskFDA
Orthopediatrics Corp
3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantag...
Medical Devices·41 affected·Jul 27, 2016
High RiskFDA
Orthopediatrics Corp
3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantag...
Medical Devices·41 affected·Jul 27, 2016
High RiskFDA
Howmedica Osteonics Corp.
AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion wit...
Medical Devices·0 affected·Jul 26, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the view...
Medical Devices·103 affected·Jul 26, 2016
High RiskFDA
Philips Electronics North America Corporation
IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need fo...
Medical Devices·50,495 affected·Jul 26, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic tre...
Medical Devices·103 affected·Jul 26, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliv...
Medical Devices·103 affected·Jul 26, 2016
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is inte...
Medical Devices·2,207 affected·Jul 25, 2016
High RiskFDA
Tecan Us, Inc.
Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance ...
Medical Devices·1 affected·Jul 25, 2016
High RiskFDA
Ge Oec Medical Systems, Inc
OEC UroView 2800, fluoroscopic x-ray system
Medical Devices·47 affected·Jul 22, 2016
High RiskFDA
Smith & Nephew, Inc.
RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for pa...
Medical Devices·45,455 affected·Jul 21, 2016
High RiskFDA
Integra Lifesciences Corp.
Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for...
Medical Devices·120 affected·Jul 21, 2016
High RiskFDA
Limacorporate S.p.a
SMR allen wrench 5 mm, product code 9013.50.210
Medical Devices·76 affected·Jul 21, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 16 Power, Model number 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional imag...
Medical Devices·50 affected·Jul 20, 2016
CriticalFDA
Orasure Technologies, Inc.
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
Medical Devices·3,075 affected·Jul 20, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 CT Model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of t...
Medical Devices·283 affected·Jul 20, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT Big Bore Oncology, Model number 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-secti...
Medical Devices·33 affected·Jul 20, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance BigBore Radiology CT Model number 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectio...
Medical Devices·24 affected·Jul 20, 2016