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.
- (1) Access Tray, Part Number (PN): ASK-04001-MS
FDA Device · Class II · 2018-04-18 · Arrow International - 5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, Sterile, Rx. The fi…
FDA Device · Class II · 2018-04-18 · Icu Medical - ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
FDA Device · Class II · 2018-04-18 · Orthofix - Normed Charcot Osteotome Chisel (Various sizes)
FDA Device · Class II · 2018-04-18 · Zimmer - PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
FDA Device · Class II · 2018-04-18 · Ethicon - VITROS Immunodiagnostic Products TSH Reagent Pack
FDA Device · Class III · 2018-04-18 · Clinical Diagnostic Systems - Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520
FDA Device · Class II · 2018-04-18 · Teleflex Medical Europe - Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are…
FDA Device · Class II · 2018-04-18 · C R Bard - VOLISTA StandOP Surgical Light
FDA Device · Class II · 2018-04-18 · Getinge Us Sales - Rectal Catheters
FDA Device · Class II · 2018-04-18 · Teleflex Medical Europe - HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator
FDA Device · Class II · 2018-04-18 · Lifeline Systems - (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP
FDA Device · Class II · 2018-04-18 · Arrow International - (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH
FDA Device · Class II · 2018-04-18 · Arrow International - Progressa Bed - AC-powered adjustable hospital bed
FDA Device · Class II · 2018-04-18 · Hill Rom - Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dial…
FDA Device · Class II · 2018-04-18 · Fresenius Medical Care Renal Therapies Group - Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are…
FDA Device · Class II · 2018-04-18 · C R Bard - IntelliVue X3 Patient Monitor
FDA Device · Class II · 2018-04-18 · Philips Electronics North America - Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153…
FDA Device · Class II · 2018-04-18 · Teleflex Medical Europe - Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters
FDA Device · Class II · 2018-04-18 · Terumo Cardiovascular Systems - 7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, Sterile, Rx. The firm na…
FDA Device · Class II · 2018-04-18 · Icu Medical - Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 (c) 650704160 551316 Pro…
FDA Device · Class II · 2018-04-18 · Teleflex Medical Europe - PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
FDA Device · Class II · 2018-04-18 · Ethicon - (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC
FDA Device · Class II · 2018-04-18 · Arrow International - ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
FDA Device · Class II · 2018-04-18 · Orthofix - Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4
FDA Device · Class II · 2018-04-18 · Arrow International - Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer
FDA Device · Class II · 2018-04-18 · Mindray Ds Usa - AQUIOS CL Flow Cytometer System, Catalog #B30166
FDA Device · Class II · 2018-04-18 · Beckman Coulter - (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP
FDA Device · Class II · 2018-04-18 · Arrow International - Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hosp…
FDA Device · Class II · 2018-04-18 · Hamilton Medical Ag - Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
FDA Device · Class II · 2018-04-18 · Gyrus Acmi - Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A
FDA Device · Class II · 2018-04-18 · Arrow International - First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM Eyewash# Size: Honeywell Part# K206125 LX…
FDA Device · Class II · 2018-04-18 · Certified Safety Mfg - Doyen-Collin Mouth Gag 120MM/ General Instruments
FDA Device · Class III · 2018-04-18 · Aesculap Implant Systems - Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of this medical device, as part of system to store and position…
FDA Device · Class II · 2018-04-18 · Reliance Medical Products - Hematology Diluent M-53D used with BC-5390 Hematology Analyzer
FDA Device · Class II · 2018-04-18 · Mindray Ds Usa - AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-…
FDA Device · Class II · 2018-04-18 · Arrow International - Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are i…
FDA Device · Class II · 2018-04-18 · C R Bard - Radial Artery Catheterization Kit
FDA Device · Class II · 2018-04-11 · Arrow International - Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case
FDA Device · Class II · 2018-04-11 · Southmedic - Dynavox T15 Speech Generating Device ( including Batteries)
FDA Device · Class II · 2018-04-11 · Dynavox Systems - ArrowClarke" PleuraSeal¿ Thoracentesis Kit
FDA Device · Class II · 2018-04-11 · Arrow International - Prismaflex Control Unit
FDA Device · Class II · 2018-04-11 · Baxter Healthcare - Radial Artery Catheterization Kit
FDA Device · Class II · 2018-04-11 · Arrow International - Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat
FDA Device · Class II · 2018-04-11 · Seiler Instr And Mfg - ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016)
FDA Device · Class II · 2018-04-11 · Phadia Us - CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI…
FDA Device · Class II · 2018-04-11 · Halyard Health - Large Volume Abdominal Paracentesis Kit
FDA Device · Class II · 2018-04-11 · Arrow International - LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample
FDA Device · Class II · 2018-04-11 · Magellan Diagnostics - HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch
FDA Device · Class II · 2018-04-11 · C R Bard - Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers…
FDA Device · Class II · 2018-04-11 · C R Bard - Radial Artery Catheterization Kit
FDA Device · Class II · 2018-04-11 · Arrow International - Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The Monica IF24 CTG Interface Device is an accessory to the…
FDA Device · Class II · 2018-04-11 · Ge Healthcare - Radial Artery Catheterization Kit
FDA Device · Class II · 2018-04-11 · Arrow International - DS Titanium Ligation Clip Appliers, used in laparoscopic surgery
FDA Device · Class II · 2018-04-11 · Aesculap Implant Systems - ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01)
FDA Device · Class II · 2018-04-11 · Phadia Us - Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch
FDA Device · Class II · 2018-04-11 · C R Bard - Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA…
FDA Device · Class II · 2018-04-11 · Roche Diagnostics - Pneumothorax Kit
FDA Device · Class II · 2018-04-11 · Arrow International - Syngo.via
FDA Device · Class II · 2018-04-11 · Siemens Medical Solutions Usa - DS Titanium Ligation Clip, used in laparoscopic surgery
FDA Device · Class II · 2018-04-11 · Aesculap Implant Systems - Radial Artery Catheterization Kit
FDA Device · Class II · 2018-04-11 · Arrow International - A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
FDA Device · Class II · 2018-04-11 · Zimmer Biomet - Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The…
FDA Device · Class II · 2018-04-11 · Depuy Spine - Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461
FDA Device · Class II · 2018-04-11 · Life Technologies - GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a de…
FDA Device · Class II · 2018-04-11 · Ge Healthcare - 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial N…
FDA Device · Class II · 2018-04-11 · Fresenius Medical Care Renal Therapies Group - Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Bi…
FDA Device · Class II · 2018-04-11 · The Binding Site Group - Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod…
FDA Device · Class II · 2018-04-11 · Ge Healthcare - Dynavox T10 Speech Generating Device ( including Batteries)
FDA Device · Class II · 2018-04-11 · Dynavox Systems - Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA…
FDA Device · Class II · 2018-04-11 · Phadia Ab - DynaCad software consist of an MR Analysis Server software and the viewer workstation software
FDA Device · Class II · 2018-04-11 · Invivo - Radial Artery Catheterization Kit
FDA Device · Class II · 2018-04-11 · Arrow International - LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only
FDA Device · Class II · 2018-04-11 · Magellan Diagnostics - Arterial Access Tray, introducer catheter
FDA Device · Class II · 2018-04-11 · Arrow International - ACE Trochanteric Nail System TROCH NAIL ST 11X180 125DG STRL TROCH NAIL ST 11X180 130DG STRL TROCH NAIL ST 11X180 135DG STRL The Trochanter…
FDA Device · Class II · 2018-04-04 · Zimmer Biomet - EasyCAL HbA1c Calibrator
FDA Device · Class II · 2018-04-04 · Medica - ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471
FDA Device · Class II · 2018-04-04 · Mesa Laboratories Bozeman Manufacturing Facility - Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use
FDA Device · Class II · 2018-04-04 · Stryker Instruments Div - QUANTA-Lyser 240 IFA, Part #GS0242
FDA Device · Class II · 2018-04-04 · Inova Diagnostics - Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System…
FDA Device · Class II · 2018-04-04 · Encore Medical - Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use
FDA Device · Class II · 2018-04-04 · Stryker Instruments Div - IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600
FDA Device · Class II · 2018-04-04 · Deerfield Imaging - Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use
FDA Device · Class II · 2018-04-04 · Stryker Instruments Div - IMRIS ORT200 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 - 1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983
FDA Device · Class II · 2018-04-04 · Stryker Instruments Div - The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a path…
FDA Device · Class II · 2018-04-04 · Stryker Instruments Div - ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 DEG X 13MM STER TROC NAIL 130 DEG X 13MM STER TROC NAIL 135 DEG X…
FDA Device · Class II · 2018-04-04 · Zimmer Biomet - IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600
FDA Device · Class II · 2018-04-04 · Deerfield Imaging - Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System…
FDA Device · Class II · 2018-04-04 · Encore Medical - Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System…
FDA Device · Class II · 2018-04-04 · Encore Medical - cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001…
FDA Device · Class II · 2018-04-04 · Roche Diagnostics - ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN LAG SCREW 70MM STERILE ATN LAG SCREW 75MM STERILE AT…
FDA Device · Class II · 2018-04-04 · Zimmer Biomet - AIM Tibial Nails intramedullary fixation rod - NON-STERILE
FDA Device · Class II · 2018-04-04 · Zimmer Biomet - 1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552
FDA Device · Class II · 2018-04-04 · Stryker Instruments Div - ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM STERILE ATN AR SCREW 70MM STERILE ATN AR SCREW 75MM STERILE ATN AR…
FDA Device · Class II · 2018-04-04 · Zimmer Biomet - c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036…
FDA Device · Class II · 2018-04-04 · Roche Diagnostics - ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL 360X9X125 STER L H TROC NAIL 380X…
FDA Device · Class II · 2018-04-04 · Zimmer Biomet - Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 0…
FDA Device · Class II · 2018-04-04 · Roche Diagnostics - ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH NAIL 12…
FDA Device · Class II · 2018-04-04 · Zimmer Biomet - Persona Partial Knee spacer block instruments
FDA Device · Class II · 2018-04-04 · Zimmer Biomet
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)