Category

Medical Devices Recalls

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

15,654 recalls
CriticalFDA
Custom Medical Specialties, Inc.
CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The...
Medical Devices·538 affected·Sep 30, 2011
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple ar...
Medical Devices·2,813 affected·Sep 30, 2011
High RiskFDA
Custom Medical Specialties, Inc.
CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep
Medical Devices·16 affected·Sep 30, 2011
CriticalFDA
Custom Medical Specialties, Inc.
CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in ski...
Medical Devices·6 affected·Sep 30, 2011
CriticalFDA
Custom Medical Specialties, Inc.
CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in sk...
Medical Devices·7 affected·Sep 30, 2011
High RiskFDA
Custom Medical Specialties, Inc.
CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep
Medical Devices·4 affected·Sep 30, 2011
CriticalFDA
Custom Medical Specialties, Inc.
CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used...
Medical Devices·3 affected·Sep 30, 2011
High RiskFDA
Custom Medical Specialties, Inc.
CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep
Medical Devices·3 affected·Sep 30, 2011
High RiskFDA
Custom Medical Specialties, Inc.
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Sol...
Medical Devices·15 affected·Sep 30, 2011
CriticalFDA
Custom Medical Specialties, Inc.
BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in th...
Medical Devices·75 affected·Sep 30, 2011
CriticalFDA
Custom Medical Specialties, Inc.
CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP contained in the kit is used in skin prep
Medical Devices·5 affected·Sep 30, 2011
High RiskFDA
Exactech, Inc.
Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Ex...
Medical Devices·16 affected·Sep 23, 2011
High RiskFDA
Intuitive Surgical, Inc.
Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
Medical Devices·0 affected·Sep 19, 2011
High RiskFDA
The Anspach Effort, Inc.
.***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only P...
Medical Devices·5 affected·Sep 19, 2011
High RiskFDA
The Anspach Effort, Inc.
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
Medical Devices·1,805,022 affected·Sep 9, 2011
High RiskFDA
Abbott Point Of Care Inc.
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
Medical Devices·6,000 affected·Sep 8, 2011
High RiskFDA
Exactech, Inc.
OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components**...
Medical Devices·193 affected·Aug 19, 2011
High RiskFDA
Codan Us Corporation
ColorSafe IV lines Catalog No.(Model No.) CS3000-R (76.7806), CS400-R (76.7800), CS408N-R (76.8000), CS3000-B (76.7807), B314 ...
Medical Devices·7,250 affected·Aug 17, 2011
RecallFDA
Sunquest Information Systems, Inc.
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
Medical Devices·47 affected·Aug 12, 2011
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of t...
Medical Devices·2 affected·Aug 12, 2011
High RiskFDA
Ge Healthcare, Llc
GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-se...
Medical Devices·166 affected·Jul 25, 2011
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
Medical Devices·636 affected·Jul 20, 2011
CriticalFDA
Baxter Healthcare Corporation
Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion P...
Medical Devices·63,225 affected·Jul 6, 2011
High RiskFDA
Epocal Inc
epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM ...
Medical Devices·8,650 affected·Jun 28, 2011
High RiskFDA
The Anspach Effort, Inc.
***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (...
Medical Devices·61 affected·Jun 24, 2011
High RiskFDA
Varian Medical Systems, Inc. Oncology Systems
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: ...
Medical Devices·3,943 affected·May 31, 2011
High RiskFDA
Bioderm, Inc.
BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protec...
Medical Devices·26,040 affected·May 31, 2011
High RiskFDA
Raysearch Laboratories Ab
The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using i...
Medical Devices·15 affected·May 30, 2011
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
Medical Devices·1 affected·May 20, 2011
High RiskFDA
Mindray Ds Usa, Inc. D.b.a. Mindray North America
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network trans...
Medical Devices·0 affected·May 12, 2011
High RiskFDA
The Anspach Effort, Inc.
Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Moto...
Medical Devices·2,020 affected·May 6, 2011
High RiskFDA
The Anspach Effort, Inc.
Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Mo...
Medical Devices·2,020 affected·May 6, 2011
CriticalFDA
Cardiogenesis Corporation
Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the treatment of patients with ang...
Medical Devices·2,498 affected·May 1, 2011
High RiskFDA
Extremity Medical Llc
IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medic...
Medical Devices·120 affected·Apr 13, 2011
High RiskFDA
The Anspach Effort, Inc.
AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting b...
Medical Devices·599 affected·Mar 31, 2011
High RiskFDA
The Anspach Effort, Inc.
Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
Medical Devices·29 affected·Mar 31, 2011
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW Volume...
Medical Devices·283 affected·Mar 25, 2011
High RiskFDA
Hospira Inc.
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. Note that Hospira ret...
Medical Devices·10,897 affected·Mar 16, 2011
High RiskFDA
Hospira Inc.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira ret...
Medical Devices·10,337 affected·Mar 16, 2011
RecallFDA
Baxter Healthcare Corp.
Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These product co...
Medical Devices·26,485 affected·Mar 4, 2011
High RiskFDA
The Anspach Effort, Inc.
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
Medical Devices·1,827 affected·Mar 4, 2011
RecallFDA
Baxter Healthcare Corp.
Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with an active time scale and rate select...
Medical Devices·19,380 affected·Mar 4, 2011
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images o...
Medical Devices·1,765 affected·Mar 3, 2011
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System ...
Medical Devices·16,579 affected·Mar 1, 2011
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replace...
Medical Devices·165 affected·Mar 1, 2011
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is...
Medical Devices·596 affected·Mar 1, 2011
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluorosco...
Medical Devices·48 affected·Feb 4, 2011
High RiskFDA
Westmed Inc
Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, w/Crickett 25g x 5/8" A Needle, 25U Balanced Heparin, part n...
Medical Devices·1,259,200 affected·Jan 18, 2011