Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Philips Medical Systems, Inc.
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, an...
Medical Devices·188,520 affected·Apr 4, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, arc...
Medical Devices·50 affected·Apr 3, 2014
High RiskFDA
B. Braun Medical, Inc.
Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia
Medical Devices·7,400 affected·Apr 3, 2014
High RiskFDA
Shimadzu Medical Systems
Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital w...
Medical Devices·685 affected·Apr 3, 2014
High RiskFDA
Boston Scientific Corporation
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
Medical Devices·9 affected·Apr 3, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, dist...
Medical Devices·373 affected·Apr 2, 2014
CriticalFDA
Baxter Corporation Englewood
ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition...
Medical Devices·2,034 affected·Apr 2, 2014
High RiskFDA
Genesys Orthopedics Systems, Llc
Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock P...
Medical Devices·642 affected·Apr 2, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer
Medical Devices·9 affected·Apr 1, 2014
CriticalFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
Medical Devices·567 affected·Apr 1, 2014
High RiskFDA
Vidacare Corporation
EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455
Medical Devices·172 affected·Mar 31, 2014
High RiskFDA
Integra Lifesciences Corporation
Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws ...
Medical Devices·417 affected·Mar 28, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
GLOBAL¿ Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product U...
Medical Devices·21,675 affected·Mar 28, 2014
High RiskFDA
Ion Beam Applications S.a.
Proteus 235 Proton Therapy System for cancer treatment.
Medical Devices·8 affected·Mar 27, 2014
High RiskFDA
Central Purchasing Llc Dba Harbor Freight Tools
Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less.
Medical Devices·43,621 affected·Mar 27, 2014
CriticalFDA
Wellspring Pharmaceutical Corporation
IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.
Medical Devices·3,135 affected·Mar 25, 2014
High RiskFDA
Allosource, Inc.
AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are no...
Medical Devices·29 affected·Mar 25, 2014
High RiskFDA
Hospira Inc.
LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation ...
Medical Devices·29,380 affected·Mar 25, 2014
High RiskFDA
Hospira Inc.
LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list 6542, 71 inch (18...
Medical Devices·42,292 affected·Mar 25, 2014
High RiskFDA
Hospira Inc.
LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; s...
Medical Devices·167,574 affected·Mar 25, 2014
High RiskFDA
Ormco/sybronendo
Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An orthodontic bracket. Spirit...
Medical Devices·150 affected·Mar 25, 2014
High RiskFDA
Kova Laboratories, Inc.
Amerigel Wound Dressing 1 oz. tube
Medical Devices·122,396 affected·Mar 21, 2014
High RiskFDA
Aspen Surgical Products, Inc.
10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
Medical Devices·0 affected·Mar 20, 2014
High RiskFDA
Aspen Surgical Products, Inc.
7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
Medical Devices·0 affected·Mar 20, 2014
High RiskFDA
Aspen Surgical Products, Inc.
Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended to provide manual suction and collection of fl...
Medical Devices·0 affected·Mar 20, 2014
High RiskFDA
Aspen Surgical Products, Inc.
10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction dra...
Medical Devices·0 affected·Mar 20, 2014
High RiskFDA
Aspen Surgical Products, Inc.
10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Medical Devices·0 affected·Mar 20, 2014
High RiskFDA
Aspen Surgical Products, Inc.
7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction dra...
Medical Devices·0 affected·Mar 20, 2014
High RiskFDA
Aspen Surgical Products, Inc.
Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suction and collection of fluids for cl...
Medical Devices·0 affected·Mar 20, 2014
High RiskFDA
Aspen Surgical Products, Inc.
15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction dr...
Medical Devices·0 affected·Mar 20, 2014
High RiskFDA
Solta Medical, Inc.
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
Medical Devices·1,077 affected·Mar 20, 2014
High RiskFDA
Aspen Surgical Products, Inc.
7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) 10 FR Drain Kit 3/4 Fluted with Trocar and 100ml ...
Medical Devices·0 affected·Mar 20, 2014
High RiskFDA
Zimmer, Inc.
Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and warmth for mild to moderate elbow strains and s...
Medical Devices·649 affected·Mar 19, 2014
High RiskFDA
Zimmer, Inc.
Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activ...
Medical Devices·546 affected·Mar 19, 2014
High RiskFDA
Rm Temena Gmbh
Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral...
Medical Devices·7,370 affected·Mar 19, 2014
RecallFDA
Nanosphere, Inc.
Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 ...
Medical Devices·78 affected·Mar 18, 2014
High RiskFDA
Energizer Personal Care
Playtex Nurser Deluxe Double Electric Breast Pump, Model X06578AO, powered by a 12V DC power supply, Model SY-12120, which is included wi...
Medical Devices·35,803 affected·Mar 18, 2014
High RiskFDA
Stryker Communications
SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attached to the service head of boom systems which are used for su...
Medical Devices·953 affected·Mar 17, 2014
High RiskFDA
Smiths Medical Asd, Inc.
Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at ...
Medical Devices·870 affected·Mar 17, 2014
High RiskFDA
Stryker Communications
SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and ...
Medical Devices·953 affected·Mar 17, 2014
High RiskFDA
Stryker Communications
BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting a...
Medical Devices·953 affected·Mar 17, 2014
High RiskFDA
Stryker Communications
BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting an...
Medical Devices·953 affected·Mar 17, 2014
High RiskFDA
Smiths Medical Asd, Inc.
Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at no...
Medical Devices·393,210 affected·Mar 17, 2014
High RiskFDA
Arjo Hospital Equipment Ab
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic ...
Medical Devices·1,695 affected·Mar 17, 2014
High RiskFDA
Claymount Assembli
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling el...
Medical Devices·125 affected·Mar 15, 2014
High RiskFDA
Breg Inc
Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support.
Medical Devices·20 affected·Mar 14, 2014
High RiskFDA
Alcon Lensx, Inc.
Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser pha...
Medical Devices·75 affected·Mar 14, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantit...
Medical Devices·76 affected·Mar 13, 2014