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.
- Pulset Arterial Blood Gas (ABG) sampling kit
FDA Device · Class II · 2012-10-31 · Westmed - Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for…
FDA Device · Class II · 2012-10-31 · Elekta - SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rot…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson - "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com**…
FDA Device · Class II · 2012-10-31 · Orthosensor - Symbiq Two Channel Infuser
FDA Device · Class I · 2012-10-31 · Hospira - AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular
FDA Device · Class II · 2012-10-31 · Nipro Medical - SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number: 222985 SPIRALOK Anchors are primarily used to re-attach soft tissue t…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson - UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218
FDA Device · Class II · 2012-10-31 · Beckman Coulter - Helion and Xenion surgical lights, 501/01 series KLM lights
FDA Device · Class II · 2012-10-24 · Trumpf Medical Systems - "***PressFT***2.1 w/ One #2 (5 metric) Hi-Fi***Suture***NP211***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To…
FDA Device · Class II · 2012-10-24 · Linvatec - "***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***…
FDA Device · Class II · 2012-10-24 · Linvatec - Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue com…
FDA Device · Class II · 2012-10-24 · Osteotech - "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***…
FDA Device · Class II · 2012-10-24 · Linvatec - Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue com…
FDA Device · Class II · 2012-10-24 · Osteotech - Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems
FDA Device · Class II · 2012-10-24 · Beckman Coulter - Belmont Rapid Infuser, a Fluid Management System, Model FMS2000
FDA Device · Class II · 2012-10-24 · Belmont Instrument - Sunquest Laboratory : intended for use by professionals working in a clinical laboratory
FDA Device · Class III · 2012-10-24 · Sunquest Information Systems - Grafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with…
FDA Device · Class II · 2012-10-24 · Osteotech - Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert…
FDA Device · Class II · 2012-10-24 · Osteotech - Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert…
FDA Device · Class II · 2012-10-24 · Osteotech - Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert ad…
FDA Device · Class II · 2012-10-24 · Osteotech - Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert add…
FDA Device · Class II · 2012-10-24 · Osteotech - "***Electric Systems Foot Control with Direction Only***Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine an…
FDA Device · Class II · 2012-10-24 · The Anspach Effort - Grafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with in…
FDA Device · Class II · 2012-10-24 · Osteotech - Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue com…
FDA Device · Class II · 2012-10-24 · Osteotech - "***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** T…
FDA Device · Class II · 2012-10-24 · Linvatec - NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical pr…
FDA Device · Class II · 2012-10-24 · Linvatec - "***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium
FDA Device · Class II · 2012-10-24 · The Anspach Effort - Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15)
FDA Device · Class II · 2012-10-24 · Boston Scientific - "***Electric Systems Foot Control with Direction and Irrigation***Rx Only***" Product Usage: Cutting and shaping bone including bones of th…
FDA Device · Class II · 2012-10-24 · The Anspach Effort - Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709
FDA Device · Class II · 2012-10-24 · Teleflex Medical - CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05
FDA Device · Class II · 2012-10-24 · Zimmer - LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25)
FDA Device · Class II · 2012-10-24 · Boston Scientific - Optimum Expanse S Multiple sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert a…
FDA Device · Class II · 2012-10-24 · Osteotech - ***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO…
FDA Device · Class II · 2012-10-24 · Moog Medical Devices Group - CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10
FDA Device · Class II · 2012-10-24 · Zimmer - Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible re…
FDA Device · Class II · 2012-10-24 · Terumo Cardiovascular Systems - Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
FDA Device · Class II · 2012-10-24 · Aesculap - Optimum Expanse R Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yiel…
FDA Device · Class II · 2012-10-24 · Osteotech - Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS Hemorrhoidal Circular Staplers, (PPH01 and PPH03), and…
FDA Device · Class I · 2012-10-24 · Ethicon Endo Surgery - Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert a…
FDA Device · Class II · 2012-10-24 · Osteotech - AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255
FDA Device · Class II · 2012-10-24 · Beckman Coulter - Leveen Coaccess Introducer Set
FDA Device · Class II · 2012-10-24 · Boston Scientific - "***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To…
FDA Device · Class II · 2012-10-24 · Linvatec - CPT Modular Stem, Item No. 00-8011-001-00
FDA Device · Class II · 2012-10-24 · Zimmer - OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque…
FDA Device · Class II · 2012-10-17 · Orthohelix Surgical Designs - TetraCXP Software System, Part Number A40051
FDA Device · Class II · 2012-10-17 · Beckman Coulter - Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures on…
FDA Device · Class II · 2012-10-17 · Terumo Cardiovascular Systems - TORQ Sternal Closure Device
FDA Device · Class II · 2012-10-17 · Kardium - CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine
FDA Device · Class I · 2012-10-17 · Accutron - Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 535 Serial No. 535A-104522***"…
FDA Device · Class II · 2012-10-17 · Winco Mfg - Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures…
FDA Device · Class II · 2012-10-17 · Terumo Cardiovascular Systems - CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013
FDA Device · Class II · 2012-10-17 · Beckman Coulter - PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Pl…
FDA Device · Class II · 2012-10-17 · Medtronic Sofamor Danek Usa - IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles
FDA Device · Class II · 2012-10-17 · Immunodiagnostics Systems - Triage TOX Drug Screen Panel, Model# 94400
FDA Device · Class II · 2012-10-17 · Alere San Diego - Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedur…
FDA Device · Class II · 2012-10-17 · Terumo Cardiovascular Systems - Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793
FDA Device · Class I · 2012-10-17 · Accutron - 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655
FDA Device · Class II · 2012-10-17 · Icu Medical - Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***" Literature: "***Carem…
FDA Device · Class II · 2012-10-17 · Winco Mfg - Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber)
FDA Device · Class I · 2012-10-17 · Baxter Healthcare - Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures on…
FDA Device · Class II · 2012-10-17 · Terumo Cardiovascular Systems - ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc.…
FDA Device · Class II · 2012-10-17 · Medtronic Sofamor Danek Usa - 3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- a…
FDA Device · Class II · 2012-10-17 · 3m Health Care Business - Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber)
FDA Device · Class I · 2012-10-17 · Baxter Healthcare - Access Folate Calibrators, Part Number: A14207
FDA Device · Class II · 2012-10-17 · Beckman Coulter - Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP)
FDA Device · Class I · 2012-10-17 · Baxter Healthcare - IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900
FDA Device · Class II · 2012-10-17 · Immunodiagnostics Systems - Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass proc…
FDA Device · Class II · 2012-10-17 · Terumo Cardiovascular Systems - IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830
FDA Device · Class II · 2012-10-17 · Immunodiagnostics Systems - Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029
FDA Device · Class II · 2012-10-17 · Beckman Coulter - The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two…
FDA Device · Class II · 2012-10-17 · Advanced Neuromodulation Systems - Access Folate WHO Calibrators, Part Number: A98033
FDA Device · Class II · 2012-10-17 · Beckman Coulter - PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Pr…
FDA Device · Class II · 2012-10-17 · Biomerieux - ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1…
FDA Device · Class II · 2012-10-17 · Medtronic Sofamor Danek Usa - IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800
FDA Device · Class II · 2012-10-17 · Immunodiagnostics Systems - Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP)
FDA Device · Class I · 2012-10-17 · Baxter Healthcare - OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque…
FDA Device · Class II · 2012-10-17 · Orthohelix Surgical Designs - IDS-iSYS Intact PINP, Catalog Number IS-4000
FDA Device · Class II · 2012-10-17 · Immunodiagnostics Systems - Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobar…
FDA Device · Class II · 2012-10-17 · Siemens Healthcare Diagnostics - Siemens syngo.plaza radiological image processing system
FDA Device · Class II · 2012-10-17 · Siemens Medical Solutions Usa - Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA
FDA Device · Class II · 2012-10-17 · Beckman Coulter - IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030
FDA Device · Class II · 2012-10-17 · Immunodiagnostics Systems - CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073
FDA Device · Class II · 2012-10-17 · Beckman Coulter - IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930
FDA Device · Class II · 2012-10-17 · Immunodiagnostics Systems - Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 3…
FDA Device · Class II · 2012-10-17 · Remington Medical - Ultra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13594, 13595, 13596, 13597, 13598, 13599, 13600, 13602, 13605, 13610, 1361…
FDA Device · Class I · 2012-10-17 · Accutron - Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737,…
FDA Device · Class I · 2012-10-17 · Accutron - Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543
FDA Device · Class II · 2012-10-10 · Philips Healthcare - MIRS for MATRIX Spine System
FDA Device · Class II · 2012-10-10 · Synthes Usa Hq - 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head P…
FDA Device · Class II · 2012-10-10 · Zimmer - Optilock T15 AO Driver (3.5mm)
FDA Device · Class II · 2012-10-10 · Biomet - Tabs Professional Voice + Monitor, with wire bracket, Model 25223
FDA Device · Class II · 2012-10-10 · Stanley Security Solutions - 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS…
FDA Device · Class II · 2012-10-10 · Zimmer - Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16
FDA Device · Class II · 2012-10-10 · Cure Medical - 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head P…
FDA Device · Class II · 2012-10-10 · Zimmer - IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system
FDA Device · Class II · 2012-10-10 · Animas - Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the applicable…
FDA Device · Class II · 2012-10-10 · Zimmer - BriteField illuminated Suction Device
FDA Device · Class II · 2012-10-10 · Invuity - Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully fea…
FDA Device · Class II · 2012-10-10 · Philips Healthcare
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)