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.
- PTS Panels Creatinine test strips
FDA Device · Class II · 2012-07-04 · Polymer Technology Systems - Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments
FDA Device · Class II · 2012-07-04 · Stryker Medical Division - Colgate 360 Replaceable Head Battery Powered Bonus Twin Pack Toothbrush Soft UPC 03500068762 Dist. by Colgate-Palmolive Co. New York, NY 10…
FDA Device · Class II · 2012-07-04 · Colgate Palmolive - Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B, OFD2223-3B,OFD2225-…
FDA Device · Class I · 2012-07-04 · Fresenius Medical Care Holdings - Colgate Adult Motion Battery Toothbrush UPC 035000686213 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China
FDA Device · Class II · 2012-07-04 · Colgate Palmolive - Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft
FDA Device · Class II · 2012-07-04 · Salter Labs - CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems - OEC Uroview 2800, Model number A349855
FDA Device · Class II · 2012-07-04 · Ge Oec Medical Systems - Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen cathet…
FDA Device · Class I · 2012-07-04 · Arrow International - Stryker Rose Bed Model (FL14E) Beds are intended for medical purposes in both general patient care as well as critical care environments
FDA Device · Class II · 2012-07-04 · Stryker Medical Division - CPB CATHETER KIT-DR BARTLES Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in th…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems - SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLUE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LONG…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems - Go Bed II+ Model FL 28 Ex Beds are intended for medical purposes in both general patient care as well as critical care environments
FDA Device · Class II · 2012-07-04 · Stryker Medical Division - Colgate 360 Replaceable Head Battery Powered Toothbrush Medium UPC03500068750 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in Chi…
FDA Device · Class II · 2012-07-04 · Colgate Palmolive - BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
FDA Device · Class II · 2012-07-04 · Siemens Healthcare Diagnostics - GoBed+ . Model FL20E Beds are intended for medical purposes in both general patient care as well as critical care environments
FDA Device · Class II · 2012-07-04 · Stryker Medical Division - Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of w…
FDA Device · Class II · 2012-07-04 · Hartmann Usa - Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: The Heartstart MRx is fo…
FDA Device · Class II · 2012-07-04 · Philips Healthcare - Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm
FDA Device · Class II · 2012-07-04 · Zimmer - ARCHITECT CA 19-9XR Reagent Kit
FDA Device · Class II · 2012-07-04 · Abbott Laboratories - MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter
FDA Device · Class II · 2012-07-04 · Medical Components - Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE NEEDLE RECTANGULAR FLANGE, 6" (15 CM) LONG Product Us…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems - Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debri…
FDA Device · Class II · 2012-07-04 · Hartmann Usa - MAYO MN XCOATED 3/8X1/2 AV Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems - XC HEART/LUNG PACK W/SX25RX Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in th…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems - X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in th…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems - MULTIGENT Acetaminophen for use with Architect/Aeroset Cat
FDA Device · Class II · 2012-07-04 · Sekisui Diagnostics - CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems - Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactur…
FDA Device · Class II · 2012-07-04 · Ethicon - Formula Shaver Handpiece (with buttons)
FDA Device · Class II · 2012-07-04 · Stryker Endoscopy - CPB CATHETER KIT- DR OWEN Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems - Advanta 2 Bed
FDA Device · Class II · 2012-07-04 · Hill Rom - GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine
FDA Device · Class I · 2012-06-27 · Ge Healthcare - seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patie…
FDA Device · Class II · 2012-06-27 · Genzyme - Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
FDA Device · Class II · 2012-06-27 · Philips Healthcare - Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inner Pouch: M00562570 The single-use Profile Polypectom…
FDA Device · Class II · 2012-06-27 · Boston Scientific - VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots
FDA Device · Class II · 2012-06-27 · Accumetrics - SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM) LONG. The Sarns High Flow Aortic Arch Cannula is i…
FDA Device · Class II · 2012-06-27 · Terumo Cardiovascular Systems - Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecolo…
FDA Device · Class II · 2012-06-27 · Covidien - NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator
FDA Device · Class I · 2012-06-27 · Nidek Medical Products - Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system
FDA Device · Class II · 2012-06-27 · Philips Healthcare - PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syring…
FDA Device · Class III · 2012-06-27 · Tripath Imaging - PrepStain Syringing Pipettes 240 (Catalog #490517)
FDA Device · Class III · 2012-06-27 · Tripath Imaging - Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for…
FDA Device · Class II · 2012-06-27 · Natus Medical - PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
FDA Device · Class III · 2012-06-27 · Tripath Imaging - USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions…
FDA Device · Class II · 2012-06-27 · Non Invasive Monitoring Systems - Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecolo…
FDA Device · Class II · 2012-06-27 · Covidien - Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France…
FDA Device · Class II · 2012-06-27 · Stryker Howmedica Osteonics - SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG. The Sarns High Flow Aortic Arch Cannula is in…
FDA Device · Class II · 2012-06-27 · Terumo Cardiovascular Systems - NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator
FDA Device · Class I · 2012-06-27 · Nidek Medical Products - HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 50…
FDA Device · Class II · 2012-06-27 · App Pharmaceuticals - SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR, CM MARKING, 10" (25 CM) LONG. The Sarns High Flow Aortic Arch Cannu…
FDA Device · Class II · 2012-06-27 · Terumo Cardiovascular Systems - Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Polypectom…
FDA Device · Class II · 2012-06-27 · Boston Scientific - Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer
FDA Device · Class II · 2012-06-27 · Ultradent Products - Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile Polypecto…
FDA Device · Class II · 2012-06-27 · Boston Scientific - NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator
FDA Device · Class I · 2012-06-27 · Nidek Medical Products - US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions…
FDA Device · Class II · 2012-06-27 · Non Invasive Monitoring Systems - SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG, WITH XCOATING SURFACE COATING. The Sarns High…
FDA Device · Class II · 2012-06-27 · Terumo Cardiovascular Systems - NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator
FDA Device · Class I · 2012-06-27 · Nidek Medical Products - PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
FDA Device · Class III · 2012-06-27 · Tripath Imaging - The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0.…
FDA Device · Class II · 2012-06-27 · Spacelabs Healthcare - SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cann…
FDA Device · Class II · 2012-06-27 · Terumo Cardiovascular Systems - Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecolo…
FDA Device · Class II · 2012-06-27 · Covidien - CPB CATHETER KIT- DR.VAN TRIGHT. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during ca…
FDA Device · Class II · 2012-06-27 · Terumo Cardiovascular Systems - SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cann…
FDA Device · Class II · 2012-06-27 · Terumo Cardiovascular Systems - Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A T…
FDA Device · Class II · 2012-06-27 · Arrow International - SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulm…
FDA Device · Class II · 2012-06-27 · Terumo Cardiovascular Systems - NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator
FDA Device · Class I · 2012-06-27 · Nidek Medical Products - NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator
FDA Device · Class I · 2012-06-27 · Nidek Medical Products - Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecolo…
FDA Device · Class II · 2012-06-27 · Covidien - seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients…
FDA Device · Class II · 2012-06-27 · Genzyme - TX1 Tissue Removal System Console
FDA Device · Class II · 2012-06-27 · American Optisurgical - HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 5…
FDA Device · Class II · 2012-06-27 · App Pharmaceuticals - 24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during car…
FDA Device · Class II · 2012-06-27 · Terumo Cardiovascular Systems - SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula…
FDA Device · Class II · 2012-06-27 · Terumo Cardiovascular Systems - Philips Multi Diagnost Eleva II with swivel cable Product Codes
FDA Device · Class II · 2012-06-27 · Philips Healthcare - Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOS…
FDA Device · Class II · 2012-06-27 · Biomet 3i - NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator
FDA Device · Class I · 2012-06-27 · Nidek Medical Products - CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiop…
FDA Device · Class II · 2012-06-27 · Terumo Cardiovascular Systems - VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of…
FDA Device · Class II · 2012-06-27 · Accumetrics - Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
FDA Device · Class III · 2012-06-27 · Tripath Imaging - NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator
FDA Device · Class I · 2012-06-27 · Nidek Medical Products - Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecolog…
FDA Device · Class II · 2012-06-27 · Covidien - NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator
FDA Device · Class I · 2012-06-27 · Nidek Medical Products - Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120
FDA Device · Class II · 2012-06-27 · Medtronic Navigation - PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery sys…
FDA Device · Class II · 2012-06-20 · Plasma Surgical - Churchill Medical Systems, Inc
FDA Device · Class II · 2012-06-20 · Vygon - Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syring…
FDA Device · Class II · 2012-06-20 · Vygon - The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reco…
FDA Device · Class II · 2012-06-20 · Philips Medical Systems Cleveland - Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box Prefilled syringes are used…
FDA Device · Class II · 2012-06-20 · Vygon - Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringe…
FDA Device · Class II · 2012-06-20 · Vygon - Churchill Medical Systems, Inc
FDA Device · Class II · 2012-06-20 · Vygon - Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pum…
FDA Device · Class I · 2012-06-20 · Baxter Healthcare - Churchill Medical Systems, Inc
FDA Device · Class II · 2012-06-20 · Vygon - Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA*** Product Usage: A fat c…
FDA Device · Class II · 2012-06-20 · Microaire Surgical Instruments - Churchill Medical Systems, Inc
FDA Device · Class II · 2012-06-20 · Vygon - Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringe…
FDA Device · Class II · 2012-06-20 · Vygon - T5 Hytrel Zipper Toga
FDA Device · Class II · 2012-06-20 · Stryker Instruments Div - GE Healthcare Revolution XR/d
FDA Device · Class II · 2012-06-20 · General Electric Med Systems - Churchill Medical Systems, Inc
FDA Device · Class II · 2012-06-20 · Vygon
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)