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.
- COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, de…
FDA Device · Class II · 2012-10-10 · Beckman Coulter - Tabs Professional Monitor, without wall bracket, Model 25023
FDA Device · Class II · 2012-10-10 · Stanley Security Solutions - Tabs Professional Monitor, without pull cord or wall bracket, Model 25025
FDA Device · Class II · 2012-10-10 · Stanley Security Solutions - 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS…
FDA Device · Class II · 2012-10-10 · 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 · 2012-10-10 · Zimmer - 12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerS…
FDA Device · Class II · 2012-10-10 · Zimmer - 00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head P…
FDA Device · Class II · 2012-10-10 · Zimmer - 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head P…
FDA Device · Class II · 2012-10-10 · Zimmer - Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland
FDA Device · Class II · 2012-10-10 · Stryker Howmedica Osteonics - 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon
FDA Device · Class II · 2012-10-10 · C R Bard Urological Division - Optilock 2.7 mm Screw Inserter
FDA Device · Class II · 2012-10-10 · Biomet - Tabs Professional Monitor, includes one wall bracket, Model 25022
FDA Device · Class II · 2012-10-10 · Stanley Security Solutions - 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS…
FDA Device · Class II · 2012-10-10 · Zimmer - Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump
FDA Device · Class II · 2012-10-10 · Accuro Medical Product - Sterile, single-use, disposable electrosurgical electrode holder
FDA Device · Class III · 2012-10-10 · Gynex - 12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerS…
FDA Device · Class II · 2012-10-10 · Zimmer - 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS…
FDA Device · Class II · 2012-10-10 · Zimmer - Endoscopic retrieval device
FDA Device · Class II · 2012-10-10 · Us Endoscopy Group - IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent,…
FDA Device · Class II · 2012-10-10 · Beckman Coulter - EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination
FDA Device · Class II · 2012-10-10 · Eos Imaging - Tabs Professional Voice + Monitor, includes one wall bracket, Model 25222
FDA Device · Class II · 2012-10-10 · Stanley Security Solutions - 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 1…
FDA Device · Class II · 2012-10-10 · Zimmer - Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035
FDA Device · Class II · 2012-10-03 · Covidien - Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use,…
FDA Device · Class II · 2012-10-03 · Linvatec - Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System…
FDA Device · Class II · 2012-10-03 · Hologic - BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro…
FDA Device · Class II · 2012-10-03 · Opti Medical Systems - Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER
FDA Device · Class II · 2012-10-03 · Applied Medical Resources - DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
FDA Device · Class II · 2012-10-03 · Imaging Sciences International - Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027…
FDA Device · Class II · 2012-10-03 · Cordis - Alere Triage TOX Drug Screen 9 Panel, P/N: 94402
FDA Device · Class II · 2012-10-03 · Alere San Diego - Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for app…
FDA Device · Class II · 2012-10-03 · Neomend - ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
FDA Device · Class II · 2012-10-03 · Linvatec - Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit
FDA Device · Class II · 2012-10-03 · Covidien - Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB
FDA Device · Class II · 2012-10-03 · Applied Medical Resources - Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit
FDA Device · Class II · 2012-10-03 · Covidien - Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit
FDA Device · Class II · 2012-10-03 · Covidien - Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit
FDA Device · Class II · 2012-10-03 · Covidien - Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit
FDA Device · Class II · 2012-10-03 · Covidien - Varian brand Eclipse Treatment Planning System, Model Number: H48
FDA Device · Class II · 2012-10-03 · Varian Medical Systems Oncology Systems - KY LIQUIBEADS Vaginal Moisturizer
FDA Device · Class II · 2012-10-03 · Mc Neil Ppc - The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in…
FDA Device · Class II · 2012-10-03 · Integra - Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific P…
FDA Device · Class II · 2012-10-03 · Greatbatch Medical - Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit
FDA Device · Class II · 2012-10-03 · Covidien - Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, O…
FDA Device · Class II · 2012-10-03 · Philips Medical Systems Cleveland - Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM
FDA Device · Class II · 2012-10-03 · Applied Medical Resources - Marathon Flow Directed Micro Catheter, Model #105-5055
FDA Device · Class II · 2012-10-03 · Micro Therapeutics - Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit
FDA Device · Class II · 2012-10-03 · Covidien - ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
FDA Device · Class II · 2012-10-03 · Linvatec - Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
FDA Device · Class II · 2012-10-03 · Siemens Medical Solutions Usa - Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 7120…
FDA Device · Class II · 2012-10-03 · Philips Healthcare - BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage pat…
FDA Device · Class II · 2012-10-03 · Kci Usa - UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065
FDA Device · Class II · 2012-10-03 · Micro Therapeutics - SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10)
FDA Device · Class II · 2012-10-03 · Raysearch Laboratories Ab - This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula toge…
FDA Device · Class II · 2012-10-03 · Alcon Research - Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688**…
FDA Device · Class II · 2012-10-03 · Cordis - Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests
FDA Device · Class III · 2012-10-03 · Clark Laboratories Dba Trinity Biotech Usa - Invacare¿ I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035
FDA Device · Class II · 2012-10-03 · Invacare - TSX-301A/2 Aquilion One CT System
FDA Device · Class II · 2012-10-03 · Toshiba American Medical Systems - The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in…
FDA Device · Class II · 2012-10-03 · Integra - Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracor…
FDA Device · Class II · 2012-10-03 · Terumo Cardiovascular Systems - Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging System de…
FDA Device · Class II · 2012-10-03 · Hologic - Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, regional pe…
FDA Device · Class II · 2012-10-03 · Terumo Cardiovascular Systems - Armada 35/ Armada 35 LL PTA Catheters
FDA Device · Class II · 2012-10-03 · Abbott Vascular - Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter
FDA Device · Class II · 2012-09-26 · Asahi Kasei Medical Okatomi Plant - 12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc
FDA Device · Class II · 2012-09-26 · Smith And Nephew - BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131
FDA Device · Class II · 2012-09-26 · Bd Biosciences Systems And Reagents - Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102
FDA Device · Class II · 2012-09-26 · Vascular Solutions - JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the…
FDA Device · Class II · 2012-09-26 · Biomet - Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan
FDA Device · Class II · 2012-09-26 · Roche Molecular Systems - Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810
FDA Device · Class II · 2012-09-26 · Davol Subs C R Bard - Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically…
FDA Device · Class II · 2012-09-26 · Instrumentation Laboratory - Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converti…
FDA Device · Class II · 2012-09-26 · Zoll Medical - Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifical…
FDA Device · Class II · 2012-09-26 · Instrumentation Laboratory - Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tub…
FDA Device · Class II · 2012-09-26 · Kimberly Clark - ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number
FDA Device · Class III · 2012-09-26 · Siemens Healthcare Diagnostics - MX 16-slice CT Scanner System, models 728131 and 728132
FDA Device · Class II · 2012-09-26 · Philips Medical Systems Cleveland - CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in…
FDA Device · Class I · 2012-09-26 · Custom Medical Specialties - CMS-4316 Custom Vein 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 - Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
FDA Device · Class II · 2012-09-26 · Asahi Kasei Medical Okatomi Plant - S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed
FDA Device · Class II · 2012-09-26 · Depuy Orthopaedics - Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers
FDA Device · Class III · 2012-09-26 · Impact Instrumentation - Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifica…
FDA Device · Class II · 2012-09-26 · Instrumentation Laboratory - Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a ta…
FDA Device · Class II · 2012-09-26 · Integra Lifesciences - Precise Digital Accelerator Delivery of radiation to defined target volumes
FDA Device · Class II · 2012-09-26 · Elekta - Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity i…
FDA Device · Class II · 2012-09-26 · Sekisui Diagnostics - Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter
FDA Device · Class II · 2012-09-26 · Asahi Kasei Medical Okatomi Plant - CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP c…
FDA Device · Class I · 2012-09-26 · Custom Medical Specialties - Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling d…
FDA Device · Class II · 2012-09-26 · Us Endoscopy Group - CMS-8495-R5 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 - Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter
FDA Device · Class II · 2012-09-26 · Asahi Kasei Medical Okatomi Plant - CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz. bottle PVP Prep Solution Pro…
FDA Device · Class I · 2012-09-26 · Custom Medical Specialties - The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sec…
FDA Device · Class III · 2012-09-26 · Philips Medical Systems Cleveland - 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashv…
FDA Device · Class III · 2012-09-26 · Amsino Medical Usa - Octopus 101 Perimeter
FDA Device · Class II · 2012-09-26 · Haag Streit Usa - 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashvi…
FDA Device · Class III · 2012-09-26 · Amsino Medical Usa - CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in sk…
FDA Device · Class I · 2012-09-26 · Custom Medical Specialties - Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators
FDA Device · Class II · 2012-09-26 · Varian Medical Systems Oncology Systems - STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table with high patient weight capacity, extended w…
FDA Device · Class II · 2012-09-26 · Steris - Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter
FDA Device · Class II · 2012-09-26 · Asahi Kasei Medical Okatomi Plant - CMS-2586 Custom Amnio Tray containing 2 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
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)