FDA Device · 2019
FDA Device recalls in 2019
RecallRadar indexes 2,801 FDA Device recall notices published in 2019. By classification: 369 Class I, 2,343 Class II, 89 Class III.
- Atellica CH 930 Analyzer
FDA Device · Class II · 2019-02-06 · Siemens Healthcare Diagnostics - Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter p…
FDA Device · Class I · 2019-02-06 · Edwards Lifesciences - SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion…
FDA Device · Class II · 2019-02-06 · Medtronic Perfusion Systems - Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component sy…
FDA Device · Class II · 2019-02-06 · Siemens Healthcare Diagnostics - Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
FDA Device · Class I · 2019-02-06 · West Pharma Services Il - 3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove body hair and head hair from…
FDA Device · Class II · 2019-02-06 · 3m Health Care Business - Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related ac…
FDA Device · Class II · 2019-02-06 · Haemonetics - Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage: The Alinit…
FDA Device · Class II · 2019-02-06 · Abbott And Kg - Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Product Usage: The PRISMAFLO IIS warmer is used fo…
FDA Device · Class II · 2019-01-30 · Stihler Electronic - VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conductio…
FDA Device · Class I · 2019-01-30 · Draeger Medical - VentStar Anesthesia WT(P) 180, Catalog Number MP00374 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduc…
FDA Device · Class I · 2019-01-30 · Draeger Medical - BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed elect…
FDA Device · Class II · 2019-01-30 · Stryker Sustainability Solutions - Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrat…
FDA Device · Class II · 2019-01-30 · Teleflex Medical - ID Circuit Watertrap (P) 180, Catalog Number MP01341 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduct…
FDA Device · Class I · 2019-01-30 · Draeger Medical - VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of res…
FDA Device · Class I · 2019-01-30 · Draeger Medical - ID Circuit Basic 250, Catalog Number MP01348 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of r…
FDA Device · Class I · 2019-01-30 · Draeger Medical - ID Circuit Basic 180, Catalog Number MP01350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of r…
FDA Device · Class I · 2019-01-30 · Draeger Medical - VentStar Basic (P) 180, Catalog Number MP00351 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of…
FDA Device · Class I · 2019-01-30 · Draeger Medical - Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 Product Usage: The PRISMAFLO IIS warmer is used fo…
FDA Device · Class II · 2019-01-30 · Stihler Electronic - 12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No./Product Code 46-5040 Fetzer Medical Obstetrical Forceps is a…
FDA Device · Class II · 2019-01-30 · Fetzer Medical And Kg - VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of…
FDA Device · Class I · 2019-01-30 · Draeger Medical - 16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 Fetzer Medical Obstetrical Forceps is a hand-he…
FDA Device · Class II · 2019-01-30 · Fetzer Medical And Kg - 12002 / Boss Instruments Ltd
FDA Device · Class II · 2019-01-30 · Fetzer Medical And Kg - Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate…
FDA Device · Class II · 2019-01-30 · Teleflex Medical - 16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Product Code 46-5050 Fetzer Medical Obstetrical Forceps is a hand-…
FDA Device · Class II · 2019-01-30 · Fetzer Medical And Kg - VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of res…
FDA Device · Class I · 2019-01-30 · Draeger Medical - Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects…
FDA Device · Class II · 2019-01-30 · Leica Microsystems - Perfusion Pack, Rx only, Sterile EO
FDA Device · Class II · 2019-01-30 · Livanova Usa - Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used fo…
FDA Device · Class II · 2019-01-30 · Stihler Electronic - Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (E…
FDA Device · Class II · 2019-01-30 · Varian Medical Systems - SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
FDA Device · Class II · 2019-01-23 · Smith And Nephew - Porcine Anorganic Bone Mineral 4.0cc
FDA Device · Class III · 2019-01-23 · Collagen Matrix - U by Kotex¿ Sleek¿, Regular/Super Tampons, 34 Count Multipack
FDA Device · Class II · 2019-01-23 · Kimberly Clark - DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric enteral feeding tube
FDA Device · Class II · 2019-01-23 · Deroyal Industries - Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .035 Digital IVUS Cathet…
FDA Device · Class II · 2019-01-23 · Volcano - PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated f…
FDA Device · Class II · 2019-01-23 · Ethicon - U by Kotex¿ Sleek¿, Regular Tampons, 34 Count
FDA Device · Class II · 2019-01-23 · Kimberly Clark - BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with m…
FDA Device · Class II · 2019-01-23 · Waldemar Link And Kg Mfg Site - Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Numb…
FDA Device · Class II · 2019-01-23 · Arthrex - U by Kotex¿ Sleek¿, Regular Tampons, 3 Count
FDA Device · Class II · 2019-01-23 · Kimberly Clark - MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra W…
FDA Device · Class II · 2019-01-23 · Bayer Medical Care - PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening…
FDA Device · Class II · 2019-01-23 · Meridian Bioscience - iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
FDA Device · Class II · 2019-01-23 · Conformis - Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product Usage: Intended to carry implants and instruments during…
FDA Device · Class II · 2019-01-23 · Zimmer Biomet - Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035 Digital IVUS Cathet…
FDA Device · Class II · 2019-01-23 · Volcano - U by Kotex¿ Sleek¿, Regular Tampons, 18 Count
FDA Device · Class II · 2019-01-23 · Kimberly Clark - LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Pro…
FDA Device · Class II · 2019-01-23 · Waldemar Link And Kg Mfg Site - MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector, 6.5Fr X 24" (60cm), REF 54-2465-R…
FDA Device · Class II · 2019-01-23 · Canadian Hospital Specialties - BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is indicated for patients with m…
FDA Device · Class II · 2019-01-23 · Waldemar Link And Kg Mfg Site - Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402…
FDA Device · Class II · 2019-01-23 · Arrow International - Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during r…
FDA Device · Class II · 2019-01-23 · Zimmer Biomet - Ingenia Elition S, Ingenia Elition X
FDA Device · Class II · 2019-01-16 · Philips Medical Systems Nederlands - DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in…
FDA Device · Class II · 2019-01-16 · Agfa Gevaert N V - Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The system is intended for stabilization and fixation of s…
FDA Device · Class II · 2019-01-16 · Zimmer Biomet - VariCam
FDA Device · Class II · 2019-01-16 · Ge Healthcare - Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use
FDA Device · Class II · 2019-01-16 · Ge Healthcare - Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed…
FDA Device · Class II · 2019-01-16 · Ion Beam Applications - PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories hav…
FDA Device · Class II · 2019-01-16 · Ethicon Endo Surgery - IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequen…
FDA Device · Class III · 2019-01-16 · Boston Scientific - Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positro…
FDA Device · Class II · 2019-01-16 · Siemens Medical Solutions Usa - MEVION S250i
FDA Device · Class II · 2019-01-16 · Mevion Medical Systems - Elekta Unity
FDA Device · Class II · 2019-01-16 · Elekta - PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE¿ HCS Hemorrhoidal Circular Stapler and Accessories ha…
FDA Device · Class II · 2019-01-16 · Ethicon Endo Surgery - Discover VH/Millennium VG Nuclear Medicine Imaging System
FDA Device · Class II · 2019-01-16 · Ge Healthcare - IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequen…
FDA Device · Class III · 2019-01-16 · Boston Scientific - Presource Kit Total Joint Pack containing a double-wrapped basin component
FDA Device · Class II · 2019-01-16 · Cardinal Health - ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifun…
FDA Device · Class II · 2019-01-16 · Swissray Medical Ag - Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for stabilization and fixatio…
FDA Device · Class II · 2019-01-16 · Zimmer Biomet - Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency…
FDA Device · Class III · 2019-01-16 · Boston Scientific - VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen…
FDA Device · Class II · 2019-01-09 · Ortho Clinical Diagnostics - VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only
FDA Device · Class II · 2019-01-09 · Ortho Clinical Diagnostics - Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 200pk Kit - Co…
FDA Device · Class II · 2019-01-09 · Ultradent Products - Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit
FDA Device · Class III · 2019-01-09 · R And D Systems - VITROS HBeAg Reagent, Cat
FDA Device · Class II · 2019-01-09 · Ortho Clinical Diagnostics - StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures u…
FDA Device · Class I · 2019-01-09 · Medtronic Navigation - AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA S…
FDA Device · Class II · 2019-01-02 · Tosoh Bioscience - ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum…
FDA Device · Class II · 2019-01-02 · Tosoh Bioscience - Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
FDA Device · Class II · 2019-01-02 · Icu Medical - ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodot…
FDA Device · Class II · 2019-01-02 · Tosoh Bioscience - Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
FDA Device · Class II · 2019-01-02 · Abbott Ireland Diagnostics Division - MOSAIQ Oncology Information System Version 2.64
FDA Device · Class II · 2019-01-02 · Elekta - HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
FDA Device · Class II · 2019-01-02 · Howmedica Osteonics - ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adren…
FDA Device · Class II · 2019-01-02 · Tosoh Bioscience - GEM Coupler Forceps, GEM4183C, packaged individually
FDA Device · Class II · 2019-01-02 · Baxter Healthcare - Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
FDA Device · Class II · 2019-01-02 · Medtronic - NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
FDA Device · Class II · 2019-01-02 · In2bones Usa - Alinity i TSH Reagent Kit, List Number 07P4830
FDA Device · Class II · 2019-01-02 · Abbott Ireland Diagnostics Division - AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human seru…
FDA Device · Class II · 2019-01-02 · Tosoh Bioscience - Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case
FDA Device · Class II · 2019-01-02 · Medical Action Industries - Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
FDA Device · Class II · 2019-01-02 · Abbott Ireland Diagnostics Division - HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE
FDA Device · Class II · 2019-01-02 · Howmedica Osteonics - Alinity i Progesterone Reagent Kit, List Number 08P3620
FDA Device · Class II · 2019-01-02 · Abbott Ireland Diagnostics Division - RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
FDA Device · Class II · 2019-01-02 · Raysearch Laboratories Ab - Alinity i Free T4 Reagent Kit, List Number 07P7030
FDA Device · Class II · 2019-01-02 · Abbott Ireland Diagnostics Division - Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
FDA Device · Class II · 2019-01-02 · Icu Medical - ABL800 analyzer, model numbers 393-800 and 393-801
FDA Device · Class II · 2019-01-02 · Radiometer America - ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum…
FDA Device · Class II · 2019-01-02 · Tosoh Bioscience - Alinity i Estradiol Reagent Kit, List Number 07P5020
FDA Device · Class II · 2019-01-02 · Abbott Ireland Diagnostics Division - I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
FDA Device · Class II · 2019-01-02 · Hologic - SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, I…
FDA Device · Class II · 2019-01-02 · Randox Laboratories
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)