Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Smith & Nephew Inc
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38...
Medical Devices·45 affected·Aug 27, 2013
CriticalFDA
H & H Associates
H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, lab...
Medical Devices·6,619 affected·Aug 27, 2013
High RiskFDA
Smith & Nephew Inc
GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 3...
Medical Devices·8 affected·Aug 27, 2013
High RiskFDA
Snug Seat Inc
Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile is a walking a...
Medical Devices·726 affected·Aug 26, 2013
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Produ...
Medical Devices·80 affected·Aug 26, 2013
High RiskFDA
Zimmer, Inc.
Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a component of the Endi...
Medical Devices·14 affected·Aug 26, 2013
High RiskFDA
Ebi, Llc
BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and ...
Medical Devices·7,092 affected·Aug 22, 2013
High RiskFDA
Itc-nexus Dx
Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. ...
Medical Devices·6 affected·Aug 22, 2013
High RiskFDA
Biomet Spine, Llc
Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills ...
Medical Devices·15 affected·Aug 22, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Nega...
Medical Devices·522 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negati...
Medical Devices·1,324 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (N...
Medical Devices·4,319 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus ...
Medical Devices·57,600 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroSc...
Medical Devices·57,600 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ R...
Medical Devices·57,600 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) -...
Medical Devices·2,158 affected·Aug 21, 2013
High RiskFDA
Aso, Llc
SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.
Medical Devices·37 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negati...
Medical Devices·1,209 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus...
Medical Devices·57,600 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids ...
Medical Devices·57,600 affected·Aug 21, 2013
High RiskFDA
Iba Dosimetry Gmbh
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
Medical Devices·33 affected·Aug 20, 2013
RecallFDA
Bio-rad Laboratories
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Medical Devices·23 affected·Aug 20, 2013
High RiskFDA
Lumenis, Inc.
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
Medical Devices·3 affected·Aug 19, 2013
High RiskFDA
Covidien Llc
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 Product Usage: Both 0.9% Sodium Chlorid...
Medical Devices·0 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Ch...
Medical Devices·3,235,860 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881590125 Product Usage: Both 0.9% Sodium Chlo...
Medical Devices·330,120 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590123 Product Usage: Both 0.9% Sodium Chlori...
Medical Devices·0 affected·Aug 16, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techn...
Medical Devices·732 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chlorid...
Medical Devices·0 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID: 8881590121 Product Usage: Both 0.9% Sodium Chlor...
Medical Devices·0 affected·Aug 16, 2013
CriticalFDA
Codman & Shurtleff, Inc.
MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream programmable pump is intended for the intrathecal de...
Medical Devices·735 affected·Aug 13, 2013
CriticalFDA
Codman & Shurtleff, Inc.
MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofe...
Medical Devices·5 affected·Aug 13, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum followin...
Medical Devices·319 affected·Aug 13, 2013
CriticalFDA
Codman & Shurtleff, Inc.
MedStream Programmable Pump; 40ml - 91-4201US Usage: The Medstream programmable pump is intended for the intrathecal delivery of Bacl...
Medical Devices·5 affected·Aug 13, 2013
CriticalFDA
Codman & Shurtleff, Inc.
MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery ...
Medical Devices·0 affected·Aug 13, 2013
CriticalFDA
Codman & Shurtleff, Inc.
MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable pump is intended for the intrathecal delivery...
Medical Devices·2 affected·Aug 13, 2013
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter,...
Medical Devices·311 affected·Aug 12, 2013
High RiskFDA
Churchill Medical Systems, Inc.
Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.
Medical Devices·13,100 affected·Aug 12, 2013
High RiskFDA
Varian Medical Systems, Inc.
VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL130110...
Medical Devices·3 affected·Aug 9, 2013
CriticalFDA
Enhancement Medical, Llc
Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Produ...
Medical Devices·17,875 affected·Aug 7, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Biodegradable suture anchor
Medical Devices·18,919 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegradable suture anchor
Medical Devices·4,452 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable suture anchor
Medical Devices·725 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor
Medical Devices·5,873 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616 Bio...
Medical Devices·2,038 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegradable suture anchor
Medical Devices·17,696 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290 Biodegradable suture anchor
Medical Devices·10,296 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 Biodegradable suture anchor
Medical Devices·1,308 affected·Aug 6, 2013