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.

• The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation…
  FDA Device · Class II · 2012-12-19 · Roche Molecular Systems
• WANG Transbronchial Aspiration Needles Cat
  FDA Device · Class II · 2012-12-19 · Conmed
• Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro diagnostic use in the quanti…
  FDA Device · Class II · 2012-12-19 · Siemens Healthcare Diagnostics
• LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid)…
  FDA Device · Class II · 2012-12-19 · Roche Molecular Systems
• Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD IN…
  FDA Device · Class II · 2012-12-19 · Quasar Bio Tech
• WANG Transbronchial Aspiration Needles Cat
  FDA Device · Class II · 2012-12-19 · Conmed
• Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide
  FDA Device · Class I · 2012-12-19 · Medtronic Neuromodulation
• MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light
  FDA Device · Class II · 2012-12-19 · Siemens Medical Solutions Usa
• Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet…
  FDA Device · Class II · 2012-12-19 · Hospira
• WANG Transbronchial Aspiration Needles Cat
  FDA Device · Class II · 2012-12-19 · Conmed
• Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASAR***…
  FDA Device · Class II · 2012-12-19 · Quasar Bio Tech
• The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various type…
  FDA Device · Class II · 2012-12-19 · Roche Molecular Systems
• Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only
  FDA Device · Class II · 2012-12-19 · Covidien
• STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324
  FDA Device · Class II · 2012-12-19 · Advanced Sterilization Products
• Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wir…
  FDA Device · Class II · 2012-12-19 · Hospira
• WANG Transbronchial Aspiration Needles Cat
  FDA Device · Class II · 2012-12-19 · Conmed
• Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US only) 00203473 Int…
  FDA Device · Class II · 2012-12-19 · Siemens Healthcare Diagnostics
• Empi STIMC RE Self Adhesive electrodes
  FDA Device · Class II · 2012-12-19 · Covidien
• Quasar Power Pack contains a Baby Quasar and a Baby Blue
  FDA Device · Class II · 2012-12-19 · Quasar Bio Tech
• LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nu…
  FDA Device · Class II · 2012-12-19 · Roche Molecular Systems
• Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro imm…
  FDA Device · Class II · 2012-12-19 · Siemens Healthcare Diagnostics
• Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is ap…
  FDA Device · Class II · 2012-12-19 · Covidien
• DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems…
  FDA Device · Class II · 2012-12-19 · Roche Molecular Systems
• 18 Fr 6mm Sft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary by…
  FDA Device · Class II · 2012-12-12 · Terumo Cardiovascular Systems
• OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablatio…
  FDA Device · Class II · 2012-12-12 · Omniguide
• Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001
  FDA Device · Class II · 2012-12-12 · Roche Diagnostics Operations
• 24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass…
  FDA Device · Class II · 2012-12-12 · Terumo Cardiovascular Systems
• Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporat…
  FDA Device · Class II · 2012-12-12 · Stryker Howmedica Osteonics
• Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determination…
  FDA Device · Class II · 2012-12-12 · Siemens Healthcare Diagnostics
• Neptune¿ 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult accompanying documents Consult instructions for use, Max…
  FDA Device · Class II · 2012-12-12 · Stryker Instruments Div
• 24 Fr 8mm Sft Flow Straight Wir The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary by…
  FDA Device · Class II · 2012-12-12 · Terumo Cardiovascular Systems
• OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide th…
  FDA Device · Class II · 2012-12-12 · Biomet
• Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1…
  FDA Device · Class II · 2012-12-12 · Sekisui Diagnostics
• The product has the Catalogue/Part number 60010
  FDA Device · Class I · 2012-12-12 · Natus Medical
• Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily u…
  FDA Device · Class II · 2012-12-12 · Biomet
• Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
  FDA Device · Class II · 2012-12-12 · Philips Healthcare
• 24 Fr 8mm Soft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary b…
  FDA Device · Class II · 2012-12-12 · Terumo Cardiovascular Systems
• NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501
  FDA Device · Class II · 2012-12-12 · Philips And Neusoft Medical Systems
• Neptune¿ 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, consult accompanying documents Consult instructions for use, Max V…
  FDA Device · Class II · 2012-12-12 · Stryker Instruments Div
• Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom procedural tray is a combin…
  FDA Device · Class II · 2012-12-12 · Merit Medical Systems
• 24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass…
  FDA Device · Class II · 2012-12-12 · Terumo Cardiovascular Systems
• Invivo Corporation Expression MRI Patient Monitoring System
  FDA Device · Class II · 2012-12-12 · Invivo
• Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS REF 6543-2-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporat…
  FDA Device · Class II · 2012-12-12 · Stryker Howmedica Osteonics
• 18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary byp…
  FDA Device · Class II · 2012-12-12 · Terumo Cardiovascular Systems
• BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number:…
  FDA Device · Class II · 2012-12-12 · Iwalk
• OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide t…
  FDA Device · Class II · 2012-12-12 · Biomet
• Siemens Mobilette Mira, intended use as Mobile x-ray system
  FDA Device · Class II · 2012-12-12 · Siemens Medical Solutions Usa
• 24 Fr 8mm Sft Flow Str Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary by…
  FDA Device · Class II · 2012-12-12 · Terumo Cardiovascular Systems
• Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
  FDA Device · Class II · 2012-12-12 · Siemens Medical Solutions Usa
• Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endos…
  FDA Device · Class II · 2012-12-05 · Cooper Surgical
• NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen¿¿ system is a semiconstrained, nonlinked condylar knee pros…
  FDA Device · Class II · 2012-12-05 · Zimmer
• GE Healthcare Optima XR 200 amx with Digital Upgrade
  FDA Device · Class II · 2012-12-05 · Ge Healthcare
• Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (…
  FDA Device · Class II · 2012-12-05 · Cooper Surgical
• Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and co…
  FDA Device · Class II · 2012-12-05 · Kimberly Clark
• The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001
  FDA Device · Class II · 2012-12-05 · Iradimed
• The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the det…
  FDA Device · Class II · 2012-12-05 · Diamedix
• Medpro Elastomeric Infusion Pump
  FDA Device · Class I · 2012-12-05 · First Medical Source
• GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima…
  FDA Device · Class II · 2012-12-05 · Ge Healthcare
• IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com
  FDA Device · Class II · 2012-12-05 · Extremity Medical
• GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima…
  FDA Device · Class II · 2012-12-05 · Ge Healthcare
• Pentron Clinical Metrex Research
  FDA Device · Class II · 2012-12-05 · Metrex Research
• Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines
  FDA Device · Class II · 2012-12-05 · Parks Medical Electronics
• 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the…
  FDA Device · Class II · 2012-12-05 · Terumo Cardiovascular Systems
• The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370)
  FDA Device · Class II · 2012-12-05 · Medtronic Navigation
• Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory dege…
  FDA Device · Class II · 2012-12-05 · Biomet
• 220/240V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the…
  FDA Device · Class II · 2012-12-05 · Terumo Cardiovascular Systems
• 6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
  FDA Device · Class II · 2012-11-28 · Nuvasive
• 0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that i…
  FDA Device · Class II · 2012-11-28 · Biomerieux
• "***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03*…
  FDA Device · Class II · 2012-11-28 · Linvatec
• Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15, 9100-15
  FDA Device · Class II · 2012-11-28 · Superstat
• bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411814 Softw…
  FDA Device · Class II · 2012-11-28 · Biomerieux
• IO Fix IntraOsseous Fixation System
  FDA Device · Class II · 2012-11-28 · Extremity Medical
• bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 4…
  FDA Device · Class II · 2012-11-28 · Biomerieux
• KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg…
  FDA Device · Class II · 2012-11-28 · King Systems
• Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a dev…
  FDA Device · Class I · 2012-11-28 · Mindray Ds Usa D B A Mindray North America
• bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 4…
  FDA Device · Class II · 2012-11-28 · Biomerieux
• 6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
  FDA Device · Class II · 2012-11-28 · Nuvasive
• 4.5mm PLEO Osteotomy Guide
  FDA Device · Class II · 2012-11-28 · Orthopediatrics
• The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either ceme…
  FDA Device · Class II · 2012-11-28 · Zimmer
• 6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
  FDA Device · Class II · 2012-11-28 · Nuvasive
• bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Tu…
  FDA Device · Class II · 2012-11-28 · Biomerieux
• bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 41…
  FDA Device · Class II · 2012-11-28 · Biomerieux
• PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
  FDA Device · Class II · 2012-11-28 · Gyrus Acmi
• Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www…
  FDA Device · Class II · 2012-11-28 · Stryker Spine
• 5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
  FDA Device · Class II · 2012-11-28 · Nuvasive
• Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthro…
  FDA Device · Class II · 2012-11-28 · Zimmer
• Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component
  FDA Device · Class II · 2012-11-28 · Biomet
• KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile
  FDA Device · Class II · 2012-11-28 · King Systems
• KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg
  FDA Device · Class II · 2012-11-28 · King Systems
• 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head P…
  FDA Device · Class II · 2012-11-28 · Zimmer
• bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument The product is most commonly used to isolate and recover s…
  FDA Device · Class II · 2012-11-28 · Biomerieux
• SenTec V-Sign Membrane Changer (VS-MC), 9 pieces
  FDA Device · Class II · 2012-11-28 · Sentec Ag
• 6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
  FDA Device · Class II · 2012-11-28 · Nuvasive
• bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update, English, Spanish, Italian, German, French, Japanes…
  FDA Device · Class II · 2012-11-28 · Biomerieux
• bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software update, English, Spanish, Italian, catalog number 41200…
  FDA Device · Class II · 2012-11-28 · Biomerieux
• Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat
  FDA Device · Class II · 2012-11-28 · Stryker Orthobiologics
• Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30
  FDA Device · Class II · 2012-11-28 · Superstat
• CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system
  FDA Device · Class II · 2012-11-28 · Captiva Spine
• bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrument The product is most commonly used to isolate and recover s…
  FDA Device · Class II · 2012-11-28 · Biomerieux
• Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411
  FDA Device · Class II · 2012-11-28 · Biomet 3i

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)