FDA Device · 2018
FDA Device recalls in 2018
RecallRadar indexes 3,757 FDA Device recall notices published in 2018. By classification: 136 Class I, 3,529 Class II, 92 Class III.
- STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit
FDA Device · Class III · 2018-04-04 · Keystone Dental - 180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for orthopedic use
FDA Device · Class II · 2018-04-04 · Stryker Instruments Div - Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox
FDA Device · Class II · 2018-04-04 · Stryker Instruments Div - PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use
FDA Device · Class II · 2018-04-04 · Stryker Instruments Div - PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheu…
FDA Device · Class II · 2018-04-04 · Zimmer Biomet - MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing,…
FDA Device · Class II · 2018-04-04 · Conmed - IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600
FDA Device · Class II · 2018-04-04 · Deerfield Imaging - Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inse…
FDA Device · Class II · 2018-04-04 · Zimmer Biomet - Teleflex MEDICAL WECK Visistat 35
FDA Device · Class II · 2018-04-04 · Teleflex Medical - Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 1in)
FDA Device · Class II · 2018-04-04 · Johnson And Johnson Consumer - QUANTA-Lyser 240 EIA, Part #GS0241
FDA Device · Class II · 2018-04-04 · Inova Diagnostics - Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulatin…
FDA Device · Class II · 2018-04-04 · Siemens Healthcare Diagnostics - ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER TROC END CAP 10MM STER TROC END CAP 15MM STER TROC END CAP 20MM S…
FDA Device · Class II · 2018-04-04 · Zimmer Biomet - MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillati…
FDA Device · Class II · 2018-04-04 · Conmed - BD Vacutainer¿ Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog Numbers: 365043, 365044, 365045…
FDA Device · Class II · 2018-04-04 · Becton Dickinson And - Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Used to pl…
FDA Device · Class II · 2018-04-04 · Cook - ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST 13X180 130DG STRL TROCH NAIL ST 13X180 135DG STRL The Trochanter…
FDA Device · Class II · 2018-04-04 · Zimmer Biomet - Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463
FDA Device · Class II · 2018-04-04 · Konica Minolta Medical Imaging Usa - Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Nec…
FDA Device · Class II · 2018-04-04 · Zimmer Biomet - Tapered Screw-Vent MTX, Dental Implant, sterile
FDA Device · Class II · 2018-04-04 · Zimmer Dental - 11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use
FDA Device · Class II · 2018-04-04 · Stryker Instruments Div - IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600
FDA Device · Class II · 2018-04-04 · Deerfield Imaging - Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images
FDA Device · Class II · 2018-04-04 · Siemens Medical Solutions Usa - Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventil…
FDA Device · Class II · 2018-04-04 · Covidien - Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to…
FDA Device · Class II · 2018-04-04 · Ohmeda Medical - ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR
FDA Device · Class II · 2018-04-04 · Johnson And Johnson Vision Care - AIM Tibial Nails intramedullary fixation rod - STERILE
FDA Device · Class II · 2018-04-04 · Zimmer Biomet - Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031
FDA Device · Class II · 2018-04-04 · Konica Minolta Medical Imaging Usa - Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor a…
FDA Device · Class III · 2018-04-04 · Mindray Ds Usa - Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery
FDA Device · Class II · 2018-04-04 · Zimmer Biomet - Tapered Screw-Vent MTX, Dental Implant, sterile
FDA Device · Class II · 2018-04-04 · Zimmer Dental - Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534
FDA Device · Class II · 2018-04-04 · Konica Minolta Medical Imaging Usa - Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Recons…
FDA Device · Class II · 2018-04-04 · Biomet - Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 3in)
FDA Device · Class II · 2018-04-04 · Johnson And Johnson Consumer - AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical ins…
FDA Device · Class II · 2018-04-04 · Encore Medical - ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 130 DEG X 9MM STER TROC NAIL 135 DEG X 9MM The Trochanteric Nail S…
FDA Device · Class II · 2018-04-04 · Zimmer Biomet - ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 DEG X 11MM STER TROC NAIL 130 DEG X 11MM STER TROC NAIL 135 DEG X…
FDA Device · Class II · 2018-04-04 · Zimmer Biomet - 6F Taiga Guiding Catheter
FDA Device · Class I · 2018-04-04 · Medtronic - The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for…
FDA Device · Class II · 2018-04-04 · Sie Ag Surgical Instrument Engineering - Proclaim DRG Implantable Pulse Generator, Model Number 3664
FDA Device · Class II · 2018-04-04 · St Jude Medical - Revolution CMS w/ Femoral Breakaway Nozzle & Med
FDA Device · Class II · 2018-04-04 · Stryker Instruments Div - ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractur…
FDA Device · Class II · 2018-04-04 · Zimmer Biomet - ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS
FDA Device · Class II · 2018-04-04 · Johnson And Johnson Vision Care - Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System…
FDA Device · Class II · 2018-04-04 · Encore Medical - Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in)
FDA Device · Class II · 2018-04-04 · Johnson And Johnson Consumer - Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices…
FDA Device · Class II · 2018-04-04 · Cook Vascular - Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022 Product Usage: Used to place in vitro ferti…
FDA Device · Class II · 2018-04-04 · Cook - Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.…
FDA Device · Class II · 2018-04-04 · Raysearch Laboratories Ab - Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 2in)
FDA Device · Class II · 2018-04-04 · Johnson And Johnson Consumer - 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108
FDA Device · Class II · 2018-04-04 · Stryker Instruments Div - F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops d…
FDA Device · Class II · 2018-04-04 · Allen Medical Systems - Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic
FDA Device · Class II · 2018-04-04 · Roche Molecular Systems - COACH¿ Self-Adhering Sports Wrap (size: 3in)
FDA Device · Class II · 2018-04-04 · Johnson And Johnson Consumer - DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent
FDA Device · Class II · 2018-04-04 · Ge Healthcare - COACH¿ Self-Adhering Sports Wrap (size: 2in)
FDA Device · Class II · 2018-04-04 · Johnson And Johnson Consumer - MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing,…
FDA Device · Class II · 2018-04-04 · Conmed - IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to…
FDA Device · Class II · 2018-04-04 · Deerfield Imaging - Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and E…
FDA Device · Class II · 2018-04-04 · Covidien - 1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses
FDA Device · Class II · 2018-04-04 · Johnson And Johnson Vision Care - First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instrume…
FDA Device · Class II · 2018-04-04 · Madison Polymeric Engineering - Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Re…
FDA Device · Class II · 2018-04-04 · Zimmer Biomet - 8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter
FDA Device · Class II · 2018-04-04 · Medical Components - 1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641
FDA Device · Class II · 2018-04-04 · Stryker Instruments Div - MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in externa…
FDA Device · Class II · 2018-04-04 · Conmed - MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing,…
FDA Device · Class II · 2018-04-04 · Conmed - Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System…
FDA Device · Class II · 2018-04-04 · Encore Medical - (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614
FDA Device · Class II · 2018-04-04 · Depuy Orthopaedics - DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous…
FDA Device · Class II · 2018-04-04 · Ge Healthcare - Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
FDA Device · Class II · 2018-04-04 · Zimmer Biomet - 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use
FDA Device · Class II · 2018-04-04 · Stryker Instruments Div - Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (I…
FDA Device · Class II · 2018-04-04 · Cook - SporAmpule Biological Indicator Catalog Number SPS5-100
FDA Device · Class II · 2018-04-04 · Mesa Laboratories Bozeman Manufacturing Facility - HEMASHIELD Knitted Double Velour Cardiovascular Fabric
FDA Device · Class II · 2018-04-04 · Getinge Us Sales - Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588
FDA Device · Class II · 2018-04-04 · Konica Minolta Medical Imaging Usa - Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro di…
FDA Device · Class II · 2018-04-04 · Quidel - ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B
FDA Device · Class II · 2018-04-04 · Arrow International - 1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182
FDA Device · Class II · 2018-04-04 · Cook - SorbaView Shield Dressing Change Tray
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - CIRCUMCISION TRAY
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision tot…
FDA Device · Class II · 2018-03-28 · Omnilife Science - Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features and Maximal Barrier…
FDA Device · Class II · 2018-03-28 · Arrow International - SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
FDA Device · Class II · 2018-03-28 · Boston Scientific - J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF
FDA Device · Class II · 2018-03-28 · Bovie Medical - Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Feat…
FDA Device · Class II · 2018-03-28 · Arrow International - MINI PLASTICS SET
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids…
FDA Device · Class II · 2018-03-28 · Smiths Medical Asd - AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography systems de…
FDA Device · Class II · 2018-03-28 · Siemens Medical Solutions Usa - INFANT IV SECUREMENT KIT
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - BLOOD DRAW KIT
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and depa…
FDA Device · Class II · 2018-03-28 · Coopersurgical - Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K1…
FDA Device · Class II · 2018-03-28 · Merit Medical Systems - NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
FDA Device · Class II · 2018-03-28 · Nxstage Medical - Situate Gauze RF and X-Ray detectable
FDA Device · Class II · 2018-03-28 · Covidien - WOUND CARE KIT
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit
FDA Device · Class II · 2018-03-28 · Arrow International - Epi proColon Plasma Quick Kit
FDA Device · Class II · 2018-03-28 · Epigenomics Ag - 12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: The Medcomp Repair Kit is indicated for use in…
FDA Device · Class II · 2018-03-28 · Medical Components - smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components…
FDA Device · Class II · 2018-03-28 · Smith And Nephew - REPAIR KIT, REF ARA101, UDI 884908083637 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connect…
FDA Device · Class II · 2018-03-28 · Medical Components - 12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 Product Usage: The Medcomp Repair Kit is indicated for use in…
FDA Device · Class II · 2018-03-28 · Medical Components
Other years
2026 (2,088) · 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)