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.
- Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231
FDA Device · Class II · 2018-06-20 · Philips Medical Systems Cleveland - Aortic Arterial Cannula 22 Fr (O.D.)
FDA Device · Class II · 2018-06-20 · Maquet Cardiopulmonary Ag - Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Byp…
FDA Device · Class II · 2018-06-20 · Datascope - RS TANDEM 5F DL XPP, Catalog Number 60M019881
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246
FDA Device · Class II · 2018-06-20 · Philips Medical Systems Cleveland - Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352
FDA Device · Class II · 2018-06-20 · Philips Electronics North America - MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116PD5
FDA Device · Class II · 2018-06-20 · Sun Med - MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1116
FDA Device · Class II · 2018-06-20 · Sun Med - RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to…
FDA Device · Class II · 2018-06-20 · Biomerieux - RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275
FDA Device · Class II · 2018-06-20 · Siemens Healthcare Diagnostics - Part #: SAM XT-C, Model: Hi-Viz Blue
FDA Device · Class II · 2018-06-20 · The Seaberg - RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - RS 5F DL BIOFLO PASV, Catalog Number 60M181578
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonol…
FDA Device · Class III · 2018-06-20 · Alere San Diego - Proteus ONE and Proteus Plus
FDA Device · Class II · 2018-06-20 · Ion Beam Applications - BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - RS 5F DL XCELA PICC, Catalog Number 60M122272
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - 5F DL BIOFLO PASV, Catalog Number 60M141006
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126
FDA Device · Class II · 2018-06-20 · Sun Med - STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1
FDA Device · Class II · 2018-06-20 · Sun Med - TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mand…
FDA Device · Class II · 2018-06-20 · Keystone Dental - Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126FP
FDA Device · Class II · 2018-06-20 · Sun Med - RS 5F DL BIOFLO PASV, Catalog Number 60M161567
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical - ST-AIA PACK AFP
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C
FDA Device · Class II · 2018-06-13 · Orthofix - Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient…
FDA Device · Class II · 2018-06-13 · Carefusion 303 - ST-AIA PACK 27.29
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors…
FDA Device · Class II · 2018-06-13 · Santa Joy Ornament And Giftware - Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
FDA Device · Class III · 2018-06-13 · Datascope - ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm
FDA Device · Class II · 2018-06-13 · Medtech Sas - BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No. 367986
FDA Device · Class II · 2018-06-13 · Becton Dickinson And - VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
FDA Device · Class II · 2018-06-13 · Vgi Medical - Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C
FDA Device · Class II · 2018-06-13 · Orthofix - H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 12MM Spacer (003-H-12001)
FDA Device · Class II · 2018-06-13 · Orthofix - nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and…
FDA Device · Class II · 2018-06-13 · Nordicneurolab As - ST-AIA PACK ¿HCG
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010) b) D 3.2MM X 12MM (…
FDA Device · Class II · 2018-06-13 · Orthofix - ST-AIA PACK FT3
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / di…
FDA Device · Class I · 2018-06-13 · Draeger Medical Systems - ST-AIA PACK CA 19-9
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - AIA-PACK TSH 3rd Generation
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)
FDA Device · Class II · 2018-06-13 · Siemens Healthcare Diagnostics - fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scan…
FDA Device · Class II · 2018-06-13 · Nordicneurolab As - ST-AIA PACK Cystatin C
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - ST-AIA DHEA-S
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / di…
FDA Device · Class I · 2018-06-13 · Draeger Medical Systems - ST-AIA PACK Myoglobin
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500…
FDA Device · Class II · 2018-06-13 · Siemens Healthcare Diagnostics - Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008), b) D 2.7MM X 10MM (002…
FDA Device · Class II · 2018-06-13 · Orthofix - ST-AIA PACK TT3
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - ST-AIA PACK Prolactin
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical i…
FDA Device · Class II · 2018-06-13 · Ge Healthcare - ST-AIA PACK BMG
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010) b) D 3.2MM X 12MM (002…
FDA Device · Class II · 2018-06-13 · Orthofix - Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label
FDA Device · Class II · 2018-06-13 · Orthofix - Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number): a) Small/0MM Step/Left (002-C-01000…
FDA Device · Class II · 2018-06-13 · Orthofix - 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy…
FDA Device · Class II · 2018-06-13 · Ion Beam Applications - ST-AIA PACK T4
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests
FDA Device · Class II · 2018-06-13 · Randox Laboratories - ST-AIA PACK PA
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
FDA Device · Class II · 2018-06-13 · Siemens Healthcare Diagnostics - 11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
FDA Device · Class II · 2018-06-13 · Ii Vi - ST-AIA PACK Cort
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formul…
FDA Device · Class II · 2018-06-13 · Fresenius Medical Care Renal Therapies Group - Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C
FDA Device · Class II · 2018-06-13 · Orthofix - ST-AIA PACK hsE2
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - ST-AIA PACK IRI
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - ST-AIA PACK C-Peptide II
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983
FDA Device · Class II · 2018-06-13 · Becton Dickinson And - ST-AIA PACK Prog II
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - ST-AIA PACK C-Peptide
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - ST-AIA PACK PAP
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - ST-AIA PACK IGE II
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
FDA Device · Class III · 2018-06-13 · Datascope - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB Product Usage: The Baxter SI…
FDA Device · Class II · 2018-06-13 · Baxter Healthcare - Restoris MCK Onlay Insert Extractor
FDA Device · Class II · 2018-06-13 · Mako Surgical - ST-AIA PACK HGH
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001)
FDA Device · Class II · 2018-06-13 · Orthofix - TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock…
FDA Device · Class II · 2018-06-13 · Orthofix Srl - 3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box
FDA Device · Class II · 2018-06-13 · Stryker - Bivona¿ Tracheostomy Tube Tracheostomy Tubes
FDA Device · Class II · 2018-06-13 · Smiths Medical Asd - ST-AIA PACK cTnI 2nd Gen
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - ST-AIA PACK Testosterone
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - ST-AIA PACK TU
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - ST-AIA PACK Estradiol
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001)
FDA Device · Class II · 2018-06-13 · Orthofix - Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM (003-F-18001)
FDA Device · Class II · 2018-06-13 · Orthofix - ST-AIA PACK CK-MB
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM Spacer (002-H-00006)
FDA Device · Class II · 2018-06-13 · Orthofix - TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020)
FDA Device · Class II · 2018-06-13 · Orthofix - ST-AIA PACK Fer
FDA Device · Class II · 2018-06-13 · Tosoh Bioscience - Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart…
FDA Device · Class II · 2018-06-13 · Invivo - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum…
FDA Device · Class II · 2018-06-13 · Baxter Healthcare
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)