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.
- Weck¿ Vista", Universal Laparoscopic Port, Size 5/10mmx100mm, Product Usage: An endoscope and accessories is a device used to provide acces…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system
FDA Device · Class II · 2014-04-02 · Bard Access Systems - Drill Template and the Saw Guide for the Ulna Osteotomy System
FDA Device · Class II · 2014-04-02 · Synthes - HeartMate II LVAD Pump and Pock Controller Kit
FDA Device · Class I · 2014-04-02 · Thoratec - Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, f…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imagi…
FDA Device · Class II · 2014-04-02 · Siemens Medical Solutions Usa - AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum
FDA Device · Class II · 2014-04-02 · Ams Diagnostics - Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monof…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - HeartMate II Implant Kit with Pocket Controller
FDA Device · Class I · 2014-04-02 · Thoratec - Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx100mm, Product Usage: An endoscope and accessories is a device used to provide acc…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mechanical device that circulates blood throughout…
FDA Device · Class I · 2014-04-02 · Thoratec - i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and meta…
FDA Device · Class II · 2014-04-02 · Abbott Point - 5/10/12 Weck¿ Vista" Universal Balloon Open Access Port Long Length (100mm), Product Usage: An endoscope and accessories is a device used…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - 5/10/12 Weck¿ Vista" Universal Balloon Open Access Port Standard Length (70mm), Product Usage: An endoscope and accessories is a device u…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - 5/10 Weck¿ Vista" Universal Balloon Open Access Port - Long Length (100mm), Product Usage: An endoscope and accessories is a device used to…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone fixatio…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.36 mm) Rx only, Ster…
FDA Device · Class II · 2014-04-02 · Medtronic Vascular - Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage: Non-absorbable polyamide surgical suture is a non-absorbable…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - 5/10 mm Weck¿, Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to provide a…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monof…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - Morph AccessPro Steerable Introducer
FDA Device · Class II · 2014-04-02 · Biocardia - HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart…
FDA Device · Class I · 2014-04-02 · Thoratec - Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, Product Usage: An endoscope and accessories is a device used to provide acc…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile
FDA Device · Class II · 2014-04-02 · Medtronic Vascular - Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbable poly(ethylene terephthalate) surgical sut…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator
FDA Device · Class III · 2014-04-02 · Lin Zhi International - Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray
FDA Device · Class II · 2014-04-02 · Siemens Medical Solutions Usa - FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile
FDA Device · Class II · 2014-04-02 · Medtronic Vascular - Ovation Prime Abdominal Stent Graft System
FDA Device · Class II · 2014-04-02 · Trivascular - D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94…
FDA Device · Class II · 2014-04-02 · Bio Rad Laboratories - 5/10 mm Weck¿, Vista" Universal Cannula, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access,…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - 5/10 Weck¿ Vista" Universal Balloon Open Access Port Short Length (53mm), Product Usage: An endoscope and accessories is a device used to…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - 5/10/12 mm Weck¿ Vista" Universal Cannula, Product Usage: An endoscope and accessories is a device used to provide access, illumination, an…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - 5/10/12 mm Weck¿ Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to provide…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum
FDA Device · Class II · 2014-04-02 · Ams Diagnostics - 5/10/12MM X 100MM Weck¿ Vista" UNIVERSAL CONE OPEN ACCESS, Product Usage: An endoscope and accessories is a device used to provide access,…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - 12mm Weck¿ Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illuminat…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicia…
FDA Device · Class II · 2014-04-02 · Velocity Medical Solutions - 10mm Weck¿ Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illuminat…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - Morph AccessPro Steerable Introducer
FDA Device · Class II · 2014-04-02 · Biocardia - 5/10 Weck¿ Vista" Universal Balloon Open Access Port - Standard Length (70mm), Product Usage: An endoscope and accessories is a device used…
FDA Device · Class II · 2014-04-02 · Teleflex Medical - MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
FDA Device · Class II · 2014-04-02 · Mevion Medical Systems - Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10
FDA Device · Class II · 2014-04-02 · Spacelabs Healthcare - AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum
FDA Device · Class II · 2014-04-02 · Ams Diagnostics - Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered
FDA Device · Class II · 2014-03-26 · China Daheng Group - Buzzaround XL scooters' Product Usage: mobility
FDA Device · Class II · 2014-03-26 · Golden Technologies - MEDITECH Microbiology
FDA Device · Class II · 2014-03-26 · Medical Information Technology - ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for imp…
FDA Device · Class III · 2014-03-26 · Biomet 3i - Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinical instrument used to correct leg length, or rotat…
FDA Device · Class II · 2014-03-26 · Biomet - Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long The Sarns Malleable Dual-stage Venous R…
FDA Device · Class II · 2014-03-26 · Terumo Cardiovascular Systems - Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instru…
FDA Device · Class II · 2014-03-26 · Biomet - Philips Model EPIQ 5 Ultrasound System
FDA Device · Class II · 2014-03-26 · Philips Medical Systems North America - Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long, with X Coating The Sarns Malleable Dual-…
FDA Device · Class II · 2014-03-26 · Terumo Cardiovascular Systems - Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Ret…
FDA Device · Class II · 2014-03-26 · Terumo Cardiovascular Systems - Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO CONG TIB INS SZ0/22MM APO CONG TIB INS SZ1/9MM APOL CONG TIB INS…
FDA Device · Class II · 2014-03-26 · Zimmer - Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTe…
FDA Device · Class II · 2014-03-26 · Biomet 3i - Apollo" Knee System: APOLLO PATELLA SZ0 28MM R
FDA Device · Class II · 2014-03-26 · Zimmer - Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long, with X Coating The Sarns Malleable Dua…
FDA Device · Class II · 2014-03-26 · Terumo Cardiovascular Systems - Natural-Knee¿ II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN CONG TIB INS SZ1/2 11MM U CONG TIB INS SZ1/2 13MM U CONG TIB…
FDA Device · Class II · 2014-03-26 · Zimmer - Natural-Knee¿ II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TI…
FDA Device · Class II · 2014-03-26 · Zimmer - Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc
FDA Device · Class II · 2014-03-26 · Clarity Medical Systems - SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essential…
FDA Device · Class II · 2014-03-26 · Convatec - Natural-Knee¿ II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UNI ALL-POLY TIB SZ 1-9mm
FDA Device · Class II · 2014-03-26 · Zimmer - SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases
FDA Device · Class II · 2014-03-26 · Elekta - Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-sta…
FDA Device · Class II · 2014-03-26 · Terumo Cardiovascular Systems - VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315
FDA Device · Class II · 2014-03-26 · Ortho Clinical Diagnostics - Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal…
FDA Device · Class II · 2014-03-26 · Exactech - Natural-Knee¿ N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1
FDA Device · Class II · 2014-03-26 · Zimmer - Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5
FDA Device · Class II · 2014-03-26 · Zimmer - DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated o…
FDA Device · Class II · 2014-03-26 · Deroyal Industries - Otto Bock Aerial and Aerial Active Wheelchair Cushions
FDA Device · Class II · 2014-03-26 · Bock Otto Orthopedic Ind - Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs)
FDA Device · Class II · 2014-03-26 · Philips Medical Systems North America - 'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essenti…
FDA Device · Class II · 2014-03-26 · Convatec - Natural-Knee¿ II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9MM POLY ULTRA TIB LT SZ0/19M POLY ULTRA TIB RT SZ0/13M POLY ULTRA…
FDA Device · Class II · 2014-03-26 · Zimmer - Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11MM AK CCK TIB INSER SZ1-16MM AK CCK TIB INSER SZ1-22MM AK CCK TIB…
FDA Device · Class II · 2014-03-26 · Zimmer - GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series o…
FDA Device · Class II · 2014-03-26 · Ge Healthcare - Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchi…
FDA Device · Class II · 2014-03-26 · Teleflex Medical - MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6MM M HINGED TIB INS SZ 4 9MM M HINGED TIB INS SZ 4 16MM MOST PROX…
FDA Device · Class II · 2014-03-26 · Zimmer - Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-sta…
FDA Device · Class II · 2014-03-26 · Terumo Cardiovascular Systems - Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters The standar…
FDA Device · Class II · 2014-03-26 · Convatec - Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instru…
FDA Device · Class II · 2014-03-26 · Biomet - Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, H…
FDA Device · Class II · 2014-03-26 · Remel - Natural-Knee¿ II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ0…
FDA Device · Class II · 2014-03-26 · Zimmer - Mar Cor Purification Millenium HX Portable Reverse Osmosis System
FDA Device · Class II · 2014-03-26 · Mar Cor Purification - FreeStyle Blood Glucose Monitors System
FDA Device · Class I · 2014-03-26 · Abbott Diabetes Care - Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devices i…
FDA Device · Class II · 2014-03-26 · Alere San Diego - SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard catheter e…
FDA Device · Class II · 2014-03-26 · Convatec - JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexib…
FDA Device · Class II · 2014-03-26 · Convatec - Natural-Knee¿/Apollo" Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KNEE M/B PAT SZ2 NATURAL-KNEE
FDA Device · Class II · 2014-03-26 · Zimmer - Natural-Knee¿ II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M ULTRA CONG INS LT SZA/19M ULTRA CONG INS RT SZA/9MM ULTRA CONG…
FDA Device · Class II · 2014-03-26 · Zimmer - Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard cat…
FDA Device · Class II · 2014-03-26 · Convatec - 2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into…
FDA Device · Class II · 2014-03-26 · Stryker Instruments Div - Philips Model EPIQ 7 Ultrasound System
FDA Device · Class II · 2014-03-26 · Philips Medical Systems North America - Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Ret…
FDA Device · Class II · 2014-03-26 · Terumo Cardiovascular Systems - Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL PS TIB INS SZ0/22MM APOLL PS TIB INS SZ1/16MM APOLL PS TIB INS SZ2…
FDA Device · Class II · 2014-03-26 · Zimmer - syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
FDA Device · Class II · 2014-03-26 · Siemens Medical Solutions Usa - FreeStyle Flash Blood Glucose Monitors System
FDA Device · Class I · 2014-03-26 · Abbott Diabetes Care - Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389
FDA Device · Class II · 2014-03-26 · Philips Medical Systems North America - Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT
FDA Device · Class II · 2014-03-26 · Zimmer - Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069
FDA Device · Class II · 2014-03-26 · Atricure
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)