Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Hospira Inc.
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used ...
Medical Devices·7,692 affected·Feb 1, 2013
High RiskFDA
Hospira Inc.
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used f...
Medical Devices·1 affected·Feb 1, 2013
High RiskFDA
Greiner Bio-one North America, Inc.
VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood...
Medical Devices·192,000 affected·Feb 1, 2013
High RiskFDA
Icu
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general...
Medical Devices·184,399 affected·Feb 1, 2013
High RiskFDA
Hospira Inc.
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used ...
Medical Devices·214 affected·Feb 1, 2013
High RiskFDA
Icu
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general...
Medical Devices·7,848 affected·Feb 1, 2013
High RiskFDA
Icu
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general...
Medical Devices·7,351 affected·Feb 1, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indi...
Medical Devices·154 affected·Feb 1, 2013
High RiskFDA
Medtronic Navigation, Inc.
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
Medical Devices·463 affected·Jan 31, 2013
High RiskFDA
Hitachi Medical Systems America Inc
Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imagi...
Medical Devices·45 affected·Jan 31, 2013
High RiskFDA
Qiagen Gaithersburg, Inc.
QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quan...
Medical Devices·90 affected·Jan 30, 2013
High RiskFDA
Conmed Corporation
ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED...
Medical Devices·97,450 affected·Jan 28, 2013
High RiskFDA
Conmed Corporation
ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CO...
Medical Devices·97,450 affected·Jan 28, 2013
High RiskFDA
Mc-neil-ppc, Inc.
KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distribu...
Medical Devices·1,185,664 affected·Jan 25, 2013
RecallFDA
Linvatec Corp. Dba Conmed Linvatec
D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of ...
Medical Devices·31 affected·Jan 24, 2013
High RiskFDA
Stelkast Co
Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for u...
Medical Devices·254 affected·Jan 24, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Sus...
Medical Devices·297 affected·Jan 21, 2013
High RiskFDA
Arjo, Inc. Dba Arjohuntleigh
Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling Lift; Model 700-19425. I...
Medical Devices·363 affected·Jan 21, 2013
High RiskFDA
Elekta, Inc.
Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
Medical Devices·1 affected·Jan 18, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business...
Medical Devices·214 affected·Jan 18, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS sys...
Medical Devices·5 affected·Jan 17, 2013
RecallFDA
Carestream Health, Inc.
KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUA...
Medical Devices·101 affected·Jan 17, 2013
High RiskFDA
Depuy Spine, Inc.
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicate...
Medical Devices·7,773 affected·Jan 15, 2013
High RiskFDA
Depuy Spine, Inc.
DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fi...
Medical Devices·6,668 affected·Jan 15, 2013
High RiskFDA
Depuy Spine, Inc.
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for...
Medical Devices·549 affected·Jan 15, 2013
High RiskFDA
Ansell Healthcare Products Llc
LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which comp...
Medical Devices·469,134 affected·Jan 14, 2013
High RiskFDA
Breg Inc
BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410...
Medical Devices·44,883 affected·Jan 14, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Den...
Medical Devices·148 affected·Jan 11, 2013
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
Medical Devices·1,920 affected·Jan 11, 2013
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Medical Devices·2,703 affected·Jan 11, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise a...
Medical Devices·18 affected·Jan 11, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
Medical Devices·18 affected·Jan 11, 2013
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
Medical Devices·625 affected·Jan 11, 2013
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Medical Devices·1,217 affected·Jan 11, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced ...
Medical Devices·4 affected·Jan 11, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
Medical Devices·2 affected·Jan 11, 2013
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Medical Devices·3,324 affected·Jan 11, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating s...
Medical Devices·328 affected·Jan 11, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) long The Sarns&...
Medical Devices·6,830 affected·Jan 7, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns&am...
Medical Devices·6,830 affected·Jan 7, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns&a...
Medical Devices·6,830 affected·Jan 7, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns&amp...
Medical Devices·6,830 affected·Jan 7, 2013
CriticalFDA
Depuy Orthopaedics, Inc.
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee pro...
Medical Devices·162 affected·Jan 4, 2013
CriticalFDA
Depuy Orthopaedics, Inc.
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee pro...
Medical Devices·162 affected·Jan 4, 2013
CriticalFDA
Depuy Orthopaedics, Inc.
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee pro...
Medical Devices·162 affected·Jan 4, 2013
High RiskFDA
Johnson & Johnson Vision Care, Inc.
ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. The Vistakon (galyfilcon A) Contact Lens is indi...
Medical Devices·3,546 affected·Dec 21, 2012
High RiskFDA
Nordicneurolab As
nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but ...
Medical Devices·36 affected·Dec 21, 2012
High RiskFDA
Johnson & Johnson Vision Care, Inc.
1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. The Vistakon (etafilcon A) Soft (hydrophilic) Contact Lens, C...
Medical Devices·36,330 affected·Dec 21, 2012