FDA Device · 2013
FDA Device recalls in 2013
RecallRadar indexes 2,249 FDA Device recall notices published in 2013. By classification: 177 Class I, 1,944 Class II, 128 Class III.
- VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK For use in the…
FDA Device · Class III · 2013-05-29 · Ortho Clinical Diagnostics - Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 44cm Length, Product numb…
FDA Device · Class II · 2013-05-29 · Progressive Medical - PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm
FDA Device · Class II · 2013-05-29 · Unimed Surgical Products - Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 33cm Length, Product numb…
FDA Device · Class II · 2013-05-29 · Progressive Medical - TD-Synergy
FDA Device · Class II · 2013-05-29 · Technidata - Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: An acetabular liner is used in combination with…
FDA Device · Class II · 2013-05-29 · Depuy Orthopaedics - Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook Split 33cm Length,Pr…
FDA Device · Class II · 2013-05-29 · Progressive Medical - Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Needle 2.75" (6.99cm) Length, Pro…
FDA Device · Class II · 2013-05-29 · Progressive Medical - SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension
FDA Device · Class II · 2013-05-29 · Separation Technology - Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Blade 6.5" (16.51cm) Length, Prod…
FDA Device · Class II · 2013-05-29 · Progressive Medical - Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Sharp Needle 2.00" (5.08cm) Lengt…
FDA Device · Class II · 2013-05-29 · Progressive Medical - Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Spatula 33cm Length, Product num…
FDA Device · Class II · 2013-05-29 · Progressive Medical - Molift Smart 150
FDA Device · Class II · 2013-05-29 · Moller Vital - MEDITECH Bi-Directional interactive Communication Analyzer Interface
FDA Device · Class II · 2013-05-29 · Medical Information Technology - Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparoscopic Electrode PTFE Coated Curved Blade 33cm Length, Product…
FDA Device · Class II · 2013-05-29 · Progressive Medical - Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook 33cm Length, Product…
FDA Device · Class II · 2013-05-29 · Progressive Medical - Molift Smart 150
FDA Device · Class II · 2013-05-29 · Moller Vital - LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely commun…
FDA Device · Class II · 2013-05-29 · Boston Scientific Crm - Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J- Hook 44cm Length, Product num…
FDA Device · Class II · 2013-05-29 · Progressive Medical - Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12
FDA Device · Class II · 2013-05-22 · Iris Diagnostics - Knife, Cold, Straight (27068K/6)
FDA Device · Class II · 2013-05-22 · Karl Storz Endoscopy America - CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for…
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100
FDA Device · Class II · 2013-05-22 · Ge Healthcare - INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and O…
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Vari…
FDA Device · Class II · 2013-05-22 · Varian Medical Systems Oncology Systems - Electrode, Roller Ball, 24FR (27050NK/6)
FDA Device · Class II · 2013-05-22 · Karl Storz Endoscopy America - NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no…
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the red…
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - Electrode, Barrel Bar, 24FR (27050NX/6)
FDA Device · Class II · 2013-05-22 · Karl Storz Endoscopy America - Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508
FDA Device · Class III · 2013-05-22 · Covidien - Loop, Cutting, Angled 22FR (26055G/6)
FDA Device · Class II · 2013-05-22 · Karl Storz Endoscopy America - Curity Staple Remover Kit
FDA Device · Class III · 2013-05-22 · Covidien - Electrode, Coag, Pointed, 24FR (27050L/6)
FDA Device · Class II · 2013-05-22 · Karl Storz Endoscopy America - Electrode, Roller, Vaporization, 24FR (27050RK/6)
FDA Device · Class II · 2013-05-22 · Karl Storz Endoscopy America - ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses
FDA Device · Class II · 2013-05-22 · Johnson And Johnson Vision Care - QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of huma…
FDA Device · Class II · 2013-05-22 · Qiagen Gaithersburg - Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, M…
FDA Device · Class II · 2013-05-22 · Summit Medical - NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by…
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - PROFILE-V MEDTOXScan Drugs of Abuse Test System
FDA Device · Class II · 2013-05-22 · Medtox Diagnostics - Loop, Cutting, 24FR (26050G/6)
FDA Device · Class II · 2013-05-22 · Karl Storz Endoscopy America - Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urological sur…
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable Collagen Membrane is an absorbable, implantable material that is…
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nuc…
FDA Device · Class II · 2013-05-22 · Qiagen Gaithersburg - Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to…
FDA Device · Class III · 2013-05-22 · Bio Rad Laboratories - Electrode, cutting, 24FR (27050G/6)
FDA Device · Class II · 2013-05-22 · Karl Storz Endoscopy America - HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for…
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guide…
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood
FDA Device · Class II · 2013-05-22 · Becton Dickinson And - Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - Absorbable Collagen Sponge Provided As Intermediate to Another Company
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than ophthalmological and urological surg…
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for…
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural de…
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - Electrode, Coag, Ball End, 24FR (27050N/6)
FDA Device · Class II · 2013-05-22 · Karl Storz Endoscopy America - BBL(tm) CDC Anaerobe 5% Sheep Blood Agar
FDA Device · Class II · 2013-05-22 · Becton Dickinson And - Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6)
FDA Device · Class II · 2013-05-22 · Karl Storz Endoscopy America - Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm Fluroscopic Imaging System designed to…
FDA Device · Class II · 2013-05-22 · Hologic - DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut…
FDA Device · Class III · 2013-05-22 · Depuy Orthopaedics - Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm
FDA Device · Class I · 2013-05-22 · Cook - PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Elec…
FDA Device · Class II · 2013-05-22 · Conmed - Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting…
FDA Device · Class II · 2013-05-22 · Insight Instruments - Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose r…
FDA Device · Class II · 2013-05-22 · Varian Medical Systems - Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended fo…
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - Electrode, cutting, 24FR (27050G-.30/6)
FDA Device · Class II · 2013-05-22 · Karl Storz Endoscopy America - Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm
FDA Device · Class I · 2013-05-22 · Cook - BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for gui…
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate
FDA Device · Class II · 2013-05-22 · Becton Dickinson And - DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
FDA Device · Class II · 2013-05-22 · Heartware - HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for…
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provid…
FDA Device · Class II · 2013-05-22 · Edwards Lifesciences - Electrode, VaporCut, 24FR (27050SG/6)
FDA Device · Class II · 2013-05-22 · Karl Storz Endoscopy America - AMS 800¿ Urinary Control System
FDA Device · Class II · 2013-05-22 · American Medical Systems - Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide ph…
FDA Device · Class II · 2013-05-22 · Hologic - AMS 800¿ Urinary Control System
FDA Device · Class II · 2013-05-22 · American Medical Systems - 1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses
FDA Device · Class II · 2013-05-22 · Johnson And Johnson Vision Care - CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for…
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for u…
FDA Device · Class II · 2013-05-22 · Integra Lifesciences - Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflective Finish
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120
FDA Device · Class III · 2013-05-15 · Spinal Elements - Wallace Sure-Pro¿ Single Stage Embryo Replacement Catheter Product Code: PP623 Sure-Pro¿ Embryo Replacement Catheters are used for the intr…
FDA Device · Class II · 2013-05-15 · Smiths Medical Asd - Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120
FDA Device · Class III · 2013-05-15 · Spinal Elements - Stryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal Finish
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal Finish
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030
FDA Device · Class III · 2013-05-15 · Spinal Elements - KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads
FDA Device · Class II · 2013-05-15 · Karl Storz Endoscopy America - Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal Finish
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - Presource PBDS, Gyn Laparoscopy Kit, Circulator
FDA Device · Class I · 2013-05-15 · Cardinal Health Medical Products And Services - Siemens Healthcare Diagnostics Inc
FDA Device · Class II · 2013-05-15 · Siemens Healthcare Diagnostics - Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090
FDA Device · Class III · 2013-05-15 · Spinal Elements - A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use on…
FDA Device · Class II · 2013-05-15 · Baxter Healthcare - Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter for difficult transfer with Stylet PPS623 Sure-Pro¿ Embryo Replacement Catheters ar…
FDA Device · Class II · 2013-05-15 · Smiths Medical Asd - Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro¿ Embryo Replacement Catheters…
FDA Device · Class II · 2013-05-15 · Smiths Medical Asd - Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100
FDA Device · Class III · 2013-05-15 · Spinal Elements - Presource PBDS, Total Hip, Kit, Circulator
FDA Device · Class I · 2013-05-15 · Cardinal Health Medical Products And Services - Presource PBDS, General Laparoscopy, Kit, Circulator
FDA Device · Class I · 2013-05-15 · Cardinal Health Medical Products And Services - Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - Presource PBDS, Knee Arthroscopy, Kit, Circulator
FDA Device · Class I · 2013-05-15 · Cardinal Health Medical Products And Services - Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040
FDA Device · Class III · 2013-05-15 · Spinal Elements
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)