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.
- INTRABEAM Balloon Applicator Set
FDA Device · Class II · 2012-11-28 · Carl Zeiss Meditec - bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument software, English, Spanish, Italian, catalog number 411815 Soft…
FDA Device · Class II · 2012-11-28 · Biomerieux - bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number…
FDA Device · Class II · 2012-11-28 · Biomerieux - Multipolar¿ Bipolar Cup Liner 22 mm LD
FDA Device · Class II · 2012-11-28 · Zimmer - 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS…
FDA Device · Class II · 2012-11-28 · Zimmer - 6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15
FDA Device · Class II · 2012-11-28 · Superstat - bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software update, German, French, catalog number 413482 Softwa…
FDA Device · Class II · 2012-11-28 · Biomerieux - KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Siz…
FDA Device · Class II · 2012-11-28 · King Systems - UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102
FDA Device · Class II · 2012-11-28 · Beckman Coulter - bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instrument The product is most commonly used to isolate and recover…
FDA Device · Class II · 2012-11-28 · Biomerieux - Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to…
FDA Device · Class II · 2012-11-28 · Vital Signs Devices A Ge Healthcare - PT Link Waterbath, Model#PT100
FDA Device · Class II · 2012-11-21 · Dako North America - Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6…
FDA Device · Class II · 2012-11-21 · Terumo Cardiovascular Systems - ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to be used by qualified medical professionals to temporarily occlude b…
FDA Device · Class II · 2012-11-21 · Zimmer - Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007
FDA Device · Class II · 2012-11-21 · Synthes Usa Hq - EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposabl…
FDA Device · Class II · 2012-11-21 · Moog Medical Devices Group - Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperatu…
FDA Device · Class II · 2012-11-21 · Terumo Cardiovascular Systems - Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6…
FDA Device · Class II · 2012-11-21 · Terumo Cardiovascular Systems - Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6…
FDA Device · Class II · 2012-11-21 · Terumo Cardiovascular Systems - Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged…
FDA Device · Class II · 2012-11-21 · Progressive Medical - Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6…
FDA Device · Class II · 2012-11-21 · Terumo Cardiovascular Systems - ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709
FDA Device · Class III · 2012-11-21 · Horiba Instruments - Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The PAR extension piece is a compone…
FDA Device · Class II · 2012-11-21 · Stryker Howmedica Osteonics - Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up…
FDA Device · Class II · 2012-11-21 · Terumo Cardiovascular Systems - TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributo…
FDA Device · Class II · 2012-11-21 · Trivascular - Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box
FDA Device · Class II · 2012-11-21 · Gulf South Medical Supply - HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature con…
FDA Device · Class II · 2012-11-21 · Terumo Cardiovascular Systems - Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up…
FDA Device · Class II · 2012-11-21 · Terumo Cardiovascular Systems - The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and he…
FDA Device · Class II · 2012-11-14 · Spacelabs Healthcare - ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35)
FDA Device · Class II · 2012-11-14 · Sendx Medical - "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery
FDA Device · Class II · 2012-11-14 · Surgical Specialties Puerto Rico - Dynesys¿ Universal spacer 6-45
FDA Device · Class II · 2012-11-14 · Zimmer - Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx
FDA Device · Class II · 2012-11-14 · Zimmer - 0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name: Mobile x-…
FDA Device · Class II · 2012-11-14 · Shimadzu Medical Systems - MS-30¿ Distal centralizer, cemented, sterile, Rx
FDA Device · Class II · 2012-11-14 · Zimmer - Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corpor…
FDA Device · Class II · 2012-11-14 · Stryker Howmedica Osteonics - Wagner cone Prosthesis, uncemented, sterile, Rx
FDA Device · Class II · 2012-11-14 · Zimmer - Zimmer Inverse/Reverse Screw system
FDA Device · Class II · 2012-11-14 · Zimmer - Metasul¿ Durom¿ Femoral component Sterile, Rx
FDA Device · Class II · 2012-11-14 · Zimmer - Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instrum…
FDA Device · Class III · 2012-11-14 · Clinical Diagnostic Solutions - Boule Con Diff US Tri Pack, 6 Vials
FDA Device · Class III · 2012-11-14 · Clinical Diagnostic Solutions - Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for pr…
FDA Device · Class II · 2012-11-14 · Sorin Group Usa - "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery
FDA Device · Class II · 2012-11-14 · Surgical Specialties Puerto Rico - Metasul¿ LDH¿ Head Rx Sterile
FDA Device · Class II · 2012-11-14 · Zimmer - Dynesys¿ L.I.S. Stabilizing cord Rx, Sterile
FDA Device · Class II · 2012-11-14 · Zimmer - Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09
FDA Device · Class III · 2012-11-14 · Abbott Point - AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512
FDA Device · Class II · 2012-11-14 · Primus Medical - NCB¿ cancellous screw
FDA Device · Class II · 2012-11-14 · Zimmer - Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instrum…
FDA Device · Class III · 2012-11-14 · Clinical Diagnostic Solutions - Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem
FDA Device · Class II · 2012-11-14 · Zimmer - Original M.E. Mueller" Low Profile Cup Sterile, Rx
FDA Device · Class II · 2012-11-14 · Zimmer - MS-30 Shaft, Sterile, Rx
FDA Device · Class II · 2012-11-14 · Zimmer - Dynesys¿ Revision + set screw
FDA Device · Class II · 2012-11-14 · Zimmer - Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxyg…
FDA Device · Class II · 2012-11-14 · Sechrist Industries - Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes…
FDA Device · Class II · 2012-11-14 · Orthopediatrics - DTO" Implant
FDA Device · Class II · 2012-11-14 · Zimmer - Fitmore" Hip Stem
FDA Device · Class II · 2012-11-14 · Zimmer - MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect surg…
FDA Device · Class II · 2012-11-14 · Kimberly Clark - CLS Stem
FDA Device · Class II · 2012-11-14 · Zimmer - Anatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx
FDA Device · Class II · 2012-11-14 · Zimmer - Anatomical Shoulder" Humeral stem
FDA Device · Class II · 2012-11-14 · Zimmer - Sysmex XE-2100 Automated Hematology System
FDA Device · Class II · 2012-11-14 · Sysmex America - Sysmex XE-5000 Automated Hematology System
FDA Device · Class II · 2012-11-14 · Sysmex America - Biolox¿ Option Ceramic Femoral Head System Rx, sterile
FDA Device · Class II · 2012-11-14 · Zimmer - Boule Con-Diff Hematology Control 9 vials
FDA Device · Class III · 2012-11-14 · Clinical Diagnostic Solutions - TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55
FDA Device · Class II · 2012-11-14 · Alphatec Spine - Kopf Adapter S Sterile, Rx
FDA Device · Class II · 2012-11-14 · Zimmer - Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later
FDA Device · Class II · 2012-11-14 · Sunquest Information Systems - CoCr Head, sterile, Rx
FDA Device · Class II · 2012-11-14 · Zimmer - Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is intended to provide 100% oxyg…
FDA Device · Class II · 2012-11-14 · Sechrist Industries - zimmer Anatomical Shoulder Glenoid S, cemented, sterile
FDA Device · Class II · 2012-11-14 · Zimmer - S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for pro…
FDA Device · Class II · 2012-11-14 · Sorin Group Usa - NCB¿-PT lateral proximal 3 hole tibial plate
FDA Device · Class II · 2012-11-14 · Zimmer - S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for proc…
FDA Device · Class II · 2012-11-14 · Sorin Group Usa - R-30H , Diagnostic X-Ray Beam-Limiting Device
FDA Device · Class II · 2012-11-14 · Shimadzu Medical Systems - 0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who c…
FDA Device · Class II · 2012-11-14 · Shimadzu Medical Systems - "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery
FDA Device · Class II · 2012-11-14 · Surgical Specialties Puerto Rico - The brand name of the device is AlgiNot, a dental impression material
FDA Device · Class II · 2012-11-14 · Kerr - Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning Syst…
FDA Device · Class II · 2012-11-14 · Philips Medical Systems Cleveland - R-20J , Diagnostic X-Ray Beam-Limiting Device
FDA Device · Class II · 2012-11-14 · Shimadzu Medical Systems - Anatomical Shoulder" Fracture Humeral stem
FDA Device · Class II · 2012-11-14 · Zimmer - ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical pati…
FDA Device · Class II · 2012-11-14 · Kimberly Clark - Anatomical Shoulder" Fracture Humeral Head
FDA Device · Class II · 2012-11-14 · Zimmer - Anatomical Shoulder" Inverse Humeral Cup
FDA Device · Class II · 2012-11-14 · Zimmer - NCB¿ screw ¿ 4.0 self-tapping
FDA Device · Class II · 2012-11-14 · Zimmer - 0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital…
FDA Device · Class II · 2012-11-14 · Shimadzu Medical Systems - AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS M…
FDA Device · Class II · 2012-11-14 · American Medical Systems - S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for pr…
FDA Device · Class II · 2012-11-14 · Sorin Group Usa - Anatomical Shoulder" Ball taper for humeral stem
FDA Device · Class II · 2012-11-14 · Zimmer - Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw
FDA Device · Class II · 2012-11-14 · Zimmer - MS-30¿ Proximal positioner
FDA Device · Class II · 2012-11-14 · Zimmer - Sirus¿ intramedullary nail for tibia, cannulated ¿
FDA Device · Class II · 2012-11-14 · Zimmer - Alloclassic SL Shaft
FDA Device · Class II · 2012-11-14 · Zimmer - Wagner SL Revision Stem, uncemented Sterile
FDA Device · Class II · 2012-11-14 · Zimmer - Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instrum…
FDA Device · Class III · 2012-11-14 · Clinical Diagnostic Solutions - Alloclassic¿ SL-Offset Stem sterile, Rx
FDA Device · Class II · 2012-11-14 · Zimmer - Dynesys¿ Set screw M6
FDA Device · Class II · 2012-11-14 · Zimmer - Anatomical Shoulder" Humeral Head
FDA Device · Class II · 2012-11-14 · Zimmer - Vector TAS Modular Driver, a manual driver for Vector TAS dental screws
FDA Device · Class II · 2012-11-14 · Ormco Sybronendo
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)