Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Abbott Medical Optics Inc (amo)
AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbin...
Medical Devices·155 affected·Dec 20, 2012
High RiskFDA
Medisystems A Nx Stage Company
Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stic...
Medical Devices·16 affected·Dec 20, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.
Medical Devices·412 affected·Dec 19, 2012
High RiskFDA
Elekta, Inc.
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy trea...
Medical Devices·164 affected·Dec 19, 2012
CriticalFDA
Ad-tech Medical Instrument Corporation
Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with recording, monitoring and stimu...
Medical Devices·144 affected·Dec 18, 2012
High RiskFDA
Mizuho Osi
Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
Medical Devices·869 affected·Dec 17, 2012
High RiskFDA
Intel-ge Care Innovations Llc
QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' move...
Medical Devices·19 affected·Dec 16, 2012
High RiskFDA
Draeger Medical, Inc.
Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patie...
Medical Devices·260 affected·Dec 13, 2012
High RiskFDA
Sr Instruments Inc
SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient Scales. Product Usage...
Medical Devices·806 affected·Dec 13, 2012
High RiskFDA
Medical Components, Inc Dba Medcomp
REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits
Medical Devices·785 affected·Dec 13, 2012
High RiskFDA
Becton Dickinson & Co.
BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA***...
Medical Devices·11,710 affected·Dec 10, 2012
High RiskFDA
Hospira Inc.
Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hype...
Medical Devices·180 affected·Dec 7, 2012
High RiskFDA
Hospira Inc.
Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) ...
Medical Devices·28,599 affected·Dec 7, 2012
High RiskFDA
Hospira Inc.
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) l...
Medical Devices·297,833 affected·Dec 7, 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·14,161 affected·Dec 5, 2012
High RiskFDA
Spacelabs Healthcare, Llc
Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The S...
Medical Devices·27 affected·Dec 5, 2012
High RiskFDA
Abbott Molecular
Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecula...
Medical Devices·215 affected·Dec 4, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. T...
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS L 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points....
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points....
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. T...
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS L 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points....
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Medtronic Neuromodulation
Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba...
Medical Devices·140 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. ...
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. ...
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. ...
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728...
Medical Devices·9 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points....
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points....
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points....
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points....
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. T...
Medical Devices·1,732 affected·Dec 3, 2012
High RiskFDA
St. Jude Medical
Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is ...
Medical Devices·75,663 affected·Nov 30, 2012
High RiskFDA
Thermo Fisher Scientific (asheville) Llc
CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585,...
Medical Devices·15,567 affected·Nov 29, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0033***Custom Autolube Food Guard***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·1 affected·Nov 28, 2012
High RiskFDA
Mindray Ds Usa, Inc. D.b.a. Mindray North America
BS-200 Chemistry Analyzer Designed for clinical laboratory use.
Medical Devices·3 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·6 affected·Nov 28, 2012
High RiskFDA
The Binding Site Group, Ltd.
Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related d...
Medical Devices·1,002 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·6 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·3 affected·Nov 28, 2012
High RiskFDA
Mindray Ds Usa, Inc. D.b.a. Mindray North America
Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central...
Medical Devices·51 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·2 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·6 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Ans...
Medical Devices·19 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty Attachment***Rx Only*** This device is intended to be used...
Medical Devices·5 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·2 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·3 affected·Nov 28, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
Medical Devices·30 affected·Nov 28, 2012