FDA Device · 2014
FDA Device recalls in 2014
RecallRadar indexes 3,059 FDA Device recall notices published in 2014. By classification: 558 Class I, 2,441 Class II, 60 Class III.
- 1488 HD 3-Chip Inline Camera
FDA Device · Class II · 2014-12-17 · Stryker Endoscopy - Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold u…
FDA Device · Class II · 2014-12-17 · Instrumed International - Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage
FDA Device · Class II · 2014-12-17 · Pfm Medical - BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a retracting needle to reduce accidental needle stick…
FDA Device · Class II · 2014-12-17 · Becton Dickinson And - Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU
FDA Device · Class I · 2014-12-17 · Nellcor Puritan Bennett Dba Covidien - Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
FDA Device · Class II · 2014-12-17 · Biomet Microfixation - Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of med…
FDA Device · Class II · 2014-12-17 · Siemens Medical Solutions Usa - Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint
FDA Device · Class II · 2014-12-17 · Biomet Microfixation - Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervic…
FDA Device · Class II · 2014-12-17 · Instrumed International - Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
FDA Device · Class II · 2014-12-17 · Biomet Microfixation - An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping an…
FDA Device · Class II · 2014-12-17 · Instrumed International - McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold und…
FDA Device · Class II · 2014-12-17 · Instrumed International - McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under…
FDA Device · Class II · 2014-12-17 · Instrumed International - 1488 HD 3-Chip Camera
FDA Device · Class II · 2014-12-17 · Stryker Endoscopy - Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage
FDA Device · Class II · 2014-12-17 · Pfm Medical - Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the…
FDA Device · Class II · 2014-12-17 · Instrumed International - Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Mil…
FDA Device · Class II · 2014-12-17 · Instrumed International - Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
FDA Device · Class II · 2014-12-17 · Biomet Microfixation - LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic
FDA Device · Class II · 2014-12-17 · Smith And Nephew - Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint
FDA Device · Class II · 2014-12-17 · Biomet Microfixation - Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force…
FDA Device · Class II · 2014-12-17 · Instrumed International - Trevo Pro 4 Stent Retriever, Model number 80021
FDA Device · Class II · 2014-12-17 · Concentric Medical - Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
FDA Device · Class II · 2014-12-17 · Biomet Microfixation - ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelli…
FDA Device · Class II · 2014-12-17 · Pfm Medical - D'errico perforator drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold und…
FDA Device · Class II · 2014-12-17 · Instrumed International - Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and C…
FDA Device · Class II · 2014-12-17 · Abbott Medical Optics Amo - A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medlin…
FDA Device · Class II · 2014-12-17 · Instrumed International - An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss…
FDA Device · Class II · 2014-12-17 · Instrumed International - Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit
FDA Device · Class II · 2014-12-17 · Invacare - Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold unde…
FDA Device · Class II · 2014-12-17 · Instrumed International - Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) in…
FDA Device · Class II · 2014-12-17 · Siemens Medical Solutions Usa - Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or disl…
FDA Device · Class II · 2014-12-17 · Instrumed International - ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainag…
FDA Device · Class II · 2014-12-17 · Pfm Medical - A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symm…
FDA Device · Class II · 2014-12-17 · Instrumed International - The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, ga…
FDA Device · Class II · 2014-12-17 · Medtronic Perfusion Systems - LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic
FDA Device · Class II · 2014-12-17 · Smith And Nephew - Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integ…
FDA Device · Class II · 2014-12-17 · Arthrocare Medical - Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine inju…
FDA Device · Class II · 2014-12-17 · Instrumed International - Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with…
FDA Device · Class II · 2014-12-17 · Conformis - 6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral acces…
FDA Device · Class II · 2014-12-17 · Pfm Medical - Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets
FDA Device · Class II · 2014-12-17 · Medtronic Minimed - Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic ac…
FDA Device · Class II · 2014-12-17 · Pfm Medical - A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold und…
FDA Device · Class II · 2014-12-17 · Instrumed International - Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a…
FDA Device · Class II · 2014-12-17 · Instrumed International - CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under t…
FDA Device · Class II · 2014-12-17 · Instrumed International - Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine inj…
FDA Device · Class II · 2014-12-17 · Instrumed International - Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold und…
FDA Device · Class II · 2014-12-17 · Instrumed International - TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
FDA Device · Class II · 2014-12-17 · Tomotherapy - Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
FDA Device · Class II · 2014-12-17 · Biomet Microfixation - ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Perit…
FDA Device · Class II · 2014-12-17 · Pfm Medical - Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
FDA Device · Class II · 2014-12-17 · Biomet Microfixation - Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of…
FDA Device · Class II · 2014-12-17 · Pfm Medical - Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160
FDA Device · Class II · 2014-12-17 · Concentric Medical - Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Telefl…
FDA Device · Class II · 2014-12-17 · Instrumed International - LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic
FDA Device · Class II · 2014-12-17 · Smith And Nephew - Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities
FDA Device · Class II · 2014-12-17 · Snug Seat - Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses for continuous nerv…
FDA Device · Class II · 2014-12-17 · Arrow International - IntellaMap Orion High Resolution Mapping Catheter
FDA Device · Class II · 2014-12-17 · Boston Scientific - Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
FDA Device · Class II · 2014-12-17 · Biomet Microfixation - 1488 HD 3-Chip Camera
FDA Device · Class II · 2014-12-17 · Stryker Endoscopy - Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under t…
FDA Device · Class II · 2014-12-17 · Instrumed International - Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile
FDA Device · Class II · 2014-12-17 · Zimmer - Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
FDA Device · Class II · 2014-12-17 · Biomet Microfixation - Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetr…
FDA Device · Class II · 2014-12-17 · Instrumed International - Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareF…
FDA Device · Class II · 2014-12-17 · Instrumed International - Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e…
FDA Device · Class II · 2014-12-17 · Instrumed International - Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
FDA Device · Class II · 2014-12-17 · Biomet Microfixation - ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT P…
FDA Device · Class II · 2014-12-17 · Pfm Medical - INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas a…
FDA Device · Class II · 2014-12-17 · Ino Therapeutics Dba Ikaria - BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consistin…
FDA Device · Class II · 2014-12-17 · Philips Medical Systems - Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the temporomandibular joint
FDA Device · Class II · 2014-12-17 · Biomet Microfixation - Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix…
FDA Device · Class II · 2014-12-17 · Instrumed International - Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fract…
FDA Device · Class II · 2014-12-17 · Instrumed International - Soft Contact Lens
FDA Device · Class II · 2014-12-17 · Cooper Vision Caribbean - Laparotomy Basic Pack, Catalog number 900-547 Used by medical staff to perform patient care procedures such as wound healing, suture remova…
FDA Device · Class I · 2014-12-10 · Customed - Basic Pack 1 (III), catalog #900-2471 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irri…
FDA Device · Class I · 2014-12-10 · Customed - Angiography Pack, Catalog number 900-2038
FDA Device · Class I · 2014-12-10 · Customed - O.B. Pack, Catalog number 900-012
FDA Device · Class I · 2014-12-10 · Customed - Amerigel Saturated Gauze Dressing Wound management
FDA Device · Class II · 2014-12-10 · Amerx Health Care - Neuro Pack, catalog #900-2256 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wou…
FDA Device · Class I · 2014-12-10 · Customed - Higado & Pancrea Pack, Catalog number 900-1966
FDA Device · Class I · 2014-12-10 · Customed - GDC-10 360 SOFT 3mm x 6cm SR
FDA Device · Class II · 2014-12-10 · Stryker Neurovascular - Surgical Pack, catalog #900-2224 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate…
FDA Device · Class I · 2014-12-10 · Customed - Amerigel Daily Dressing Packets Wound management
FDA Device · Class II · 2014-12-10 · Amerx Health Care - Laparotomy Pack, catalog #900-2829 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigat…
FDA Device · Class I · 2014-12-10 · Customed - ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONN…
FDA Device · Class I · 2014-12-10 · Conmed - Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522
FDA Device · Class I · 2014-12-10 · Customed - Shoulder Pack, catalog #900-2616 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate…
FDA Device · Class I · 2014-12-10 · Customed - Laparoscopy Pack, Catalog number 900-1967
FDA Device · Class I · 2014-12-10 · Customed - Cirugia Cardiovascular Case Cart, Catalog number 900-1415A. Used by medical staff to perform patient care procedures such as wound healing,…
FDA Device · Class I · 2014-12-10 · Customed - Universal Drainage Tray, Catalog number 900-032
FDA Device · Class I · 2014-12-10 · Customed - Cysto Tur Pack, Catalog number 900-430 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irr…
FDA Device · Class I · 2014-12-10 · Customed - Laparoscopy Pack, Catalog number 900-028
FDA Device · Class I · 2014-12-10 · Customed - Cysto Tur Pack, Catalog number 900-080
FDA Device · Class I · 2014-12-10 · Customed - Liposuction Pack, catalog #900-2656 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irriga…
FDA Device · Class I · 2014-12-10 · Customed - Pediatric Lap Pack, Catalog number 900-1383 Used by medical staff to perform patient care procedures such as wound healing, suture removals…
FDA Device · Class I · 2014-12-10 · Customed - Premium Cesarean Pack, Catalog number 900-1294 Used by medical staff to perform patient care procedures such as wound healing, suture remov…
FDA Device · Class I · 2014-12-10 · Customed - Gown Surgical Non Reinforced XL, Catalog number 900-1579
FDA Device · Class I · 2014-12-10 · Customed - O.B. Pack, Catalog number 900-645
FDA Device · Class I · 2014-12-10 · Customed - INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system
FDA Device · Class II · 2014-12-10 · Alcon Research
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)