FDA Device · 2012
FDA Device recalls in 2012
RecallRadar indexes 1,310 FDA Device recall notices published in 2012. By classification: 95 Class I, 1,162 Class II, 53 Class III.
- Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifica…
FDA Device · Class II · 2012-09-26 · Instrumentation Laboratory - Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products bran…
FDA Device · Class II · 2012-09-26 · Tedan Surgical Innovations - Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically…
FDA Device · Class II · 2012-09-26 · Instrumentation Laboratory - Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790
FDA Device · Class II · 2012-09-26 · Davol Subs C R Bard - ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File
FDA Device · Class III · 2012-09-26 · Kimberly Clark - The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220
FDA Device · Class II · 2012-09-26 · Bio Rad Laboratories - Verify¿ Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verify Bowie-Dick Test…
FDA Device · Class II · 2012-09-26 · Steris - CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin…
FDA Device · Class I · 2012-09-26 · Custom Medical Specialties - Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic syste…
FDA Device · Class II · 2012-09-26 · Integra Lifesciences - Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
FDA Device · Class II · 2012-09-26 · Philips Healthcare - Ultraview SL 91493 Integrated Module Housing
FDA Device · Class II · 2012-09-26 · Spacelabs Healthcare - CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin p…
FDA Device · Class I · 2012-09-26 · Custom Medical Specialties - Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections
FDA Device · Class II · 2012-09-26 · Hospira - Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for moni…
FDA Device · Class II · 2012-09-26 · Zoe Medical - CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
FDA Device · Class I · 2012-09-26 · Custom Medical Specialties - Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes inte…
FDA Device · Class II · 2012-09-26 · Kimberly Clark - Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter
FDA Device · Class II · 2012-09-26 · Asahi Kasei Medical Okatomi Plant - Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifica…
FDA Device · Class II · 2012-09-26 · Instrumentation Laboratory - BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit…
FDA Device · Class I · 2012-09-26 · Custom Medical Specialties - The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Sta…
FDA Device · Class II · 2012-09-26 · Integra Life Sci - A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table
FDA Device · Class II · 2012-09-26 · Steris - Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter
FDA Device · Class II · 2012-09-26 · Asahi Kasei Medical Okatomi Plant - The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1 . To determine if the version you are using is…
FDA Device · Class II · 2012-09-26 · Raysearch Laboratories Ab - ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577…
FDA Device · Class III · 2012-09-26 · Siemens Healthcare Diagnostics - CMS-4501-R1 Custom HSG Tray containing 2 oz
FDA Device · Class I · 2012-09-26 · Custom Medical Specialties - HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085
FDA Device · Class II · 2012-09-26 · Covidien - STERRAD 100S Cassette, Batch # 12A077
FDA Device · Class III · 2012-09-19 · Advanced Sterilization Products - 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
FDA Device · Class II · 2012-09-19 · Custom Medical Specialties - Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system
FDA Device · Class II · 2012-09-19 · Siemens Medical Solutions Usa - Siemens Uroskop Access
FDA Device · Class II · 2012-09-19 · Siemens Medical Solutions Usa - CARTO 3 V1.05(FG-5400-00)
FDA Device · Class II · 2012-09-19 · Biosense Webster - GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems
FDA Device · Class II · 2012-09-19 · Ge Healthcare - Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060
FDA Device · Class II · 2012-09-19 · Omni Life Science - Bard Foley procedural trays packaged in breather bags
FDA Device · Class II · 2012-09-19 · C R Bard Urological Division - REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gain…
FDA Device · Class II · 2012-09-19 · Exactech - REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gain…
FDA Device · Class II · 2012-09-19 · Exactech - Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic a…
FDA Device · Class II · 2012-09-19 · Lucero Medical - Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10
FDA Device · Class II · 2012-09-19 · Intuitive Surgical - Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.0…
FDA Device · Class II · 2012-09-19 · Volcano - Optima XR200amx
FDA Device · Class II · 2012-09-19 · Ge Healthcare - Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro)
FDA Device · Class II · 2012-09-19 · Medtronic Xomed - Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010
FDA Device · Class II · 2012-09-19 · Omni Life Science - REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gain…
FDA Device · Class II · 2012-09-19 · Exactech - CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep
FDA Device · Class II · 2012-09-19 · Custom Medical Specialties - SUN|DASH RADIUS 252 tanning system
FDA Device · Class II · 2012-09-19 · Jk Products And Services - The SYSTEM 1E Liquid Sterilant Processing System
FDA Device · Class II · 2012-09-19 · Steris - BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved…
FDA Device · Class III · 2012-09-19 · Helix Medical - STERRAD NX Cassette, Batch # 12A078
FDA Device · Class III · 2012-09-19 · Advanced Sterilization Products - CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
FDA Device · Class II · 2012-09-19 · Custom Medical Specialties - Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030
FDA Device · Class II · 2012-09-19 · Omni Life Science - Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse)
FDA Device · Class II · 2012-09-19 · Medtronic Xomed - Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 82…
FDA Device · Class II · 2012-09-19 · Medtronic Xomed - Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory
FDA Device · Class II · 2012-09-19 · Sunquest Information Systems - Optima XR220amx Mobile general purpose radiographic imaging of the human head and body
FDA Device · Class II · 2012-09-19 · Ge Healthcare - REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gain…
FDA Device · Class II · 2012-09-19 · Exactech - CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep
FDA Device · Class II · 2012-09-19 · Custom Medical Specialties - Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extrac…
FDA Device · Class II · 2012-09-19 · Terumo Cardiovascular Systems - Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045
FDA Device · Class II · 2012-09-19 · Hospira - Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040
FDA Device · Class II · 2012-09-19 · Omni Life Science - REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gain…
FDA Device · Class II · 2012-09-19 · Exactech - REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gain…
FDA Device · Class II · 2012-09-19 · Exactech - Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050
FDA Device · Class II · 2012-09-19 · Omni Life Science - Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anter…
FDA Device · Class II · 2012-09-19 · Aesculap Implant Systems - Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC-NU-DS-CK The Capsule Neuron Docking Sta…
FDA Device · Class II · 2012-09-19 · Capsule Tech - Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536…
FDA Device · Class II · 2012-09-19 · Philips Healthcare - Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of th…
FDA Device · Class II · 2012-09-19 · Elekta - Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020
FDA Device · Class II · 2012-09-19 · Omni Life Science - BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique,…
FDA Device · Class II · 2012-09-12 · Becton Dickinson And - V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to…
FDA Device · Class I · 2012-09-12 · Respironics California - Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. The BioSign Flu A + B test is an…
FDA Device · Class II · 2012-09-12 · Princeton Biomeditech - OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***R…
FDA Device · Class II · 2012-09-12 · Exactech - Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVI…
FDA Device · Class II · 2012-09-12 · Siemens Healthcare Diagnostics - TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpre…
FDA Device · Class II · 2012-09-12 · Quality Electrodynamics - 100 ft roll of tubing inside a cardboard box
FDA Device · Class III · 2012-09-12 · Steris - Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim
FDA Device · Class II · 2012-09-12 · Trumpf Medical Systems - Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vit…
FDA Device · Class II · 2012-09-12 · Princeton Biomeditech - AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com
FDA Device · Class II · 2012-09-12 · Ameriwater - Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform th…
FDA Device · Class II · 2012-09-12 · Capintec - Siemens Mobilett Mira
FDA Device · Class II · 2012-09-12 · Siemens Medical Solutions Usa - Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage
FDA Device · Class II · 2012-09-12 · Toshiba American Medical Systems - BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Qu…
FDA Device · Class II · 2012-09-12 · Becton Dickinson And - VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System
FDA Device · Class III · 2012-09-12 · Trek Diagnostic Systems - BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, QC,…
FDA Device · Class II · 2012-09-12 · Becton Dickinson And - Brand name: RayStation
FDA Device · Class II · 2012-09-12 · Raysearch Laboratories Ab - BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du Parc-Technologique,…
FDA Device · Class II · 2012-09-12 · Becton Dickinson And - Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus
FDA Device · Class I · 2012-09-12 · Newport Medical Instruments - syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions
FDA Device · Class II · 2012-09-12 · Siemens Healthcare Diagnostics - Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and pati…
FDA Device · Class II · 2012-09-12 · Breg An Orthofix - BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologi…
FDA Device · Class II · 2012-09-12 · Becton Dickinson And - Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-7…
FDA Device · Class II · 2012-09-12 · Princeton Biomeditech - Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplas…
FDA Device · Class II · 2012-09-12 · Cook Ireland - ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System
FDA Device · Class II · 2012-09-05 · Sendx Medical - 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm
FDA Device · Class II · 2012-09-05 · Encore Medical - Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received a…
FDA Device · Class II · 2012-09-05 · Toshiba American Medical Systems - Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer…
FDA Device · Class III · 2012-09-05 · Siemens Healthcare Diagnostics - Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***Co…
FDA Device · Class II · 2012-09-05 · Unimed Surgical Products - OEC IT3000
FDA Device · Class I · 2012-09-05 · Ge Oec Medical Systems - Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reorder: ES0013***Contents: 1 Each***SINGLE U…
FDA Device · Class II · 2012-09-05 · Unimed Surgical Products - CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000
FDA Device · Class II · 2012-09-05 · Metrex Research - Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 15…
FDA Device · Class II · 2012-09-05 · Atlas Spine
Other years
2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)