FDA Device · 2016
FDA Device recalls in 2016
RecallRadar indexes 3,246 FDA Device recall notices published in 2016. By classification: 116 Class I, 3,050 Class II, 80 Class III.
- Philips Healthcare DuraDiagnost stationary X-ray system
FDA Device · Class II · 2016-06-15 · Philips Healthcare - Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-Lactate…
FDA Device · Class II · 2016-06-15 · Beckman Coulter - Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, M…
FDA Device · Class II · 2016-06-15 · Medical Components - Norian Drillable Inject 10 CC-Sterile
FDA Device · Class II · 2016-06-15 · Synthes Usa Products - Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal SlingBar" 350 R2R, Universal SlingBar" 450, Univer…
FDA Device · Class II · 2016-06-15 · Hill Rom - The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural inf…
FDA Device · Class II · 2016-06-15 · Hospira - Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter is intended to connect the FlowPort II Cannulas to commercial…
FDA Device · Class II · 2016-06-15 · Stryker - Persona Trabecular Metal Tibia
FDA Device · Class II · 2016-06-15 · Zimmer Biomet - Philips Healthcare Ingenuity Core Computed Tomography X-Ray System
FDA Device · Class II · 2016-06-15 · Philips Healthcare - Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products
FDA Device · Class II · 2016-06-15 · Ellipse A S - MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
FDA Device · Class II · 2016-06-15 · Ge Healthcare - Sedecal SA Mobile Diagnost w DR x-ray system
FDA Device · Class II · 2016-06-15 · Sedecal Usa - Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System
FDA Device · Class II · 2016-06-15 · Philips Healthcare - Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric A…
FDA Device · Class II · 2016-06-15 · Beckman Coulter - CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
FDA Device · Class II · 2016-06-15 · Alcon Research - ExacTrac Vero is a Patient Positioning System for Radiation therapy
FDA Device · Class II · 2016-06-15 · Brainlab Ag - Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Ch…
FDA Device · Class II · 2016-06-15 · Beckman Coulter - Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd
FDA Device · Class II · 2016-06-15 · Remel - 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Flo…
FDA Device · Class II · 2016-06-15 · Synthes Usa Products - VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measur…
FDA Device · Class II · 2016-06-15 · Ortho Clinical Diagnostics - 4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluo…
FDA Device · Class II · 2016-06-15 · Greiner Bio One North America - Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem
FDA Device · Class II · 2016-06-08 · Exactech - Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 66 cm) Item Number: 4031
FDA Device · Class II · 2016-06-08 · Covidien - Ergon III Series Skyboom Monitor Bracket
FDA Device · Class II · 2016-06-08 · Skytron Div The Kmw Group - Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
FDA Device · Class II · 2016-06-08 · Fujifilm Medical Systems U - Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical pro…
FDA Device · Class II · 2016-06-08 · Sterilmed - Curity" X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8" x 36" (20.3 cm x 91.4 cm) Item Number: 6556
FDA Device · Class II · 2016-06-08 · Covidien - Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the…
FDA Device · Class II · 2016-06-08 · Leica Microsystems - Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13
FDA Device · Class II · 2016-06-08 · Exactech - Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
FDA Device · Class II · 2016-06-08 · Integra Lifesciences - Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage
FDA Device · Class II · 2016-06-08 · Fujifilm Medical Systems U - Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321
FDA Device · Class II · 2016-06-08 · Covidien - Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number: 6022
FDA Device · Class II · 2016-06-08 · Covidien - Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item Number: 4037
FDA Device · Class II · 2016-06-08 · Covidien - Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319
FDA Device · Class II · 2016-06-08 · Covidien - Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit
FDA Device · Class II · 2016-06-08 · Windstone Medical Packaging - Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Intended to produce cross-sectional images of the body by computer reconst…
FDA Device · Class II · 2016-06-08 · Philips Medical Systems Cleveland - Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry
FDA Device · Class II · 2016-06-08 · Microaire Surgical Instruments - Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reco…
FDA Device · Class II · 2016-06-08 · Philips Medical Systems Cleveland - Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
FDA Device · Class II · 2016-06-08 · Integra Lifesciences - Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument
FDA Device · Class II · 2016-06-08 · Integra York Pa - Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch
FDA Device · Class II · 2016-06-08 · Covidien - Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbe…
FDA Device · Class II · 2016-06-08 · Siemens Healthcare Diagnostics - Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem
FDA Device · Class II · 2016-06-08 · Exactech - Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56
FDA Device · Class II · 2016-06-08 · Exactech - Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44
FDA Device · Class II · 2016-06-08 · Natus Medical - Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4" x 18" (10.2 cm x 45.7 cm) Item Number: 6545
FDA Device · Class II · 2016-06-08 · Covidien - Video Duodenoscope
FDA Device · Class II · 2016-06-08 · Pentax Medical - Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial number…
FDA Device · Class II · 2016-06-08 · Siemens Healthcare Diagnostics - SEAL,IS4000 PORTS,5MM-8MM,BOX of 10
FDA Device · Class II · 2016-06-08 · Intuitive Surgical - CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-732…
FDA Device · Class II · 2016-06-08 · Smiths Medical Asd - Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x 43.2 cm) Item Number: 4034
FDA Device · Class II · 2016-06-08 · Covidien - Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiat…
FDA Device · Class II · 2016-06-08 · Elekta - General Surgery Pack, part number 006880-3. This is a custom convenience surgical instrument disposable kit
FDA Device · Class II · 2016-06-08 · Windstone Medical Packaging - EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monit…
FDA Device · Class II · 2016-06-08 · Olympus - Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer
FDA Device · Class II · 2016-06-08 · Greatbatch Medical - Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534
FDA Device · Class II · 2016-06-08 · Covidien - Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91.4 cm Item Number: 6056
FDA Device · Class II · 2016-06-08 · Covidien - Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstructio…
FDA Device · Class II · 2016-06-08 · Philips Medical Systems Cleveland - COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072
FDA Device · Class II · 2016-06-08 · Baxter Healthcare - STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical situa…
FDA Device · Class II · 2016-06-08 · Ventlab - Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS…
FDA Device · Class II · 2016-06-08 · Conmed - Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
FDA Device · Class II · 2016-06-08 · Fujifilm Medical Systems U - Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct
FDA Device · Class II · 2016-06-08 · Orthofix - AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001)
FDA Device · Class II · 2016-06-08 · Medscience - Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenience surgical instrument disposable kit
FDA Device · Class II · 2016-06-08 · Windstone Medical Packaging - Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues
FDA Device · Class II · 2016-06-08 · Leica Microsystems - Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile
FDA Device · Class II · 2016-06-08 · Greatbatch Medical - Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstru…
FDA Device · Class II · 2016-06-08 · Philips Medical Systems Cleveland - Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54
FDA Device · Class II · 2016-06-08 · Exactech - EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose Surgical Table Skytron EZ Slide…
FDA Device · Class II · 2016-06-08 · Skytron Div The Kmw Group - COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070
FDA Device · Class II · 2016-06-08 · Baxter Healthcare - The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma
FDA Device · Class II · 2016-06-08 · Abbott Laboratories - Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number:6522
FDA Device · Class II · 2016-06-08 · Covidien - SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10
FDA Device · Class II · 2016-06-08 · Intuitive Surgical - Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem, Catalog Number 160-00-14
FDA Device · Class II · 2016-06-08 · Exactech - CytoScan¿ Dx Assay
FDA Device · Class III · 2016-06-08 · Affymetrix - Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047
FDA Device · Class II · 2016-06-08 · Covidien - Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid…
FDA Device · Class II · 2016-06-08 · B Braun Medical - Endoscope
FDA Device · Class II · 2016-06-08 · Fujifilm Medical Systems U - COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071
FDA Device · Class II · 2016-06-08 · Baxter Healthcare - Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
FDA Device · Class II · 2016-06-08 · Fujifilm Medical Systems U - Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only
FDA Device · Class II · 2016-06-08 · Greatbatch Medical - Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted b…
FDA Device · Class II · 2016-06-08 · B Braun Medical - American Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - American Surgical Delicot 9 mm x 50 mm Ref Number: 63-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - American Surgical Delicot-J 5 mm x 8 mm Ref Number: 63-01J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - American Surgical Uniqcot 1/2" x 3" Ref Number: 67-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - American Surgical Delicot non-xray 10 mm x 13 mm Ref Number: 63-03 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - American Surgical Cotton Balls-Non-Strung 1" Ref Number: 31-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - American Surgical Ultracot 20 mm x 60 mm (Glassine) Ref Number: 23-09G Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - American Surgical Delicot non-xray 5 mm x 8 mm Ref Number: 63-01 Non X-Ray Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - American Surgical Ray-Cot 1/2" x 1" Ref Number: 60-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - Various trauma and sports medicine instruments and implants
FDA Device · Class II · 2016-06-01 · Biomet - American Surgical Ultracot 30 mm x 70 mm Ref Number: 23-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles
FDA Device · Class II · 2016-06-01 · Draeger Medical - American Surgical Uniqcot 1/4" x 1/4" Ref Number: 67-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical
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)