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.
- Titanium Hexed Uniscrew Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple…
FDA Device · Class II · 2016-08-24 · Mindray Ds Usa - Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, p…
FDA Device · Class II · 2016-08-24 · Baxter Healthcare - Standard Abutment Transfer Coping Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - DAL-RO Threaded Female Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Certain EP Healing Abutment 5mm(D) x 6mm(P) x 4mm(H) Item: IWTH564 Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton
FDA Device · Class II · 2016-08-17 · Invacare - Brilliance iCT, Model No. 728306
FDA Device · Class II · 2016-08-17 · Philips Medical Systems Cleveland - VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2…
FDA Device · Class II · 2016-08-17 · Ortho Clinical Diagnostics - STAPLER 30, IS4000, model number 470430
FDA Device · Class II · 2016-08-17 · Intuitive Surgical - Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provid…
FDA Device · Class II · 2016-08-17 · Invacare - Ingenuity Core Model No. 728321
FDA Device · Class II · 2016-08-17 · Philips Medical Systems Cleveland - Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Star…
FDA Device · Class II · 2016-08-17 · Synthes Usa Products - Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstr…
FDA Device · Class II · 2016-08-17 · Philips Medical Systems Cleveland - MX 16-slice SKD whole body computed tomography X-ray system
FDA Device · Class II · 2016-08-17 · Philips Medical Systems Cleveland - Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connec…
FDA Device · Class II · 2016-08-17 · Nobel Biocare Usa - Brilliance iCT SP Model No. 728311
FDA Device · Class II · 2016-08-17 · Philips Medical Systems Cleveland - Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system
FDA Device · Class II · 2016-08-17 · Stryker Howmedica Osteonics - Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-…
FDA Device · Class II · 2016-08-17 · Philips Medical Systems Cleveland - NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extra…
FDA Device · Class I · 2016-08-17 · Biomerieux - Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S Product Usage: Is a reu…
FDA Device · Class II · 2016-08-17 · Stryker Howmedica Osteonics - Brilliance 64 CT Model 728231
FDA Device · Class II · 2016-08-17 · Philips Medical Systems Cleveland - BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD)
FDA Device · Class III · 2016-08-17 · Becton Dickinson And Bd Biosciences - Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle, 125 per case
FDA Device · Class II · 2016-08-17 · Richard Allan Scientific - Ingenuity Core128 Model No. 728323
FDA Device · Class II · 2016-08-17 · Philips Medical Systems Cleveland - Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
FDA Device · Class II · 2016-08-17 · Hitachi Medical Systems America - Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication
FDA Device · Class II · 2016-08-17 · Medline Industries - CURVED-TIP STAPLER 30,IS4000, model number 470530
FDA Device · Class II · 2016-08-17 · Intuitive Surgical - Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-r…
FDA Device · Class II · 2016-08-17 · Philips Medical Systems Cleveland - Merge PACS software
FDA Device · Class II · 2016-08-17 · Merge Healthcare - Integra External Fixation System Slotted Post - Small Catalogue #12224228
FDA Device · Class II · 2016-08-17 · Integra Lifesciences - Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959,…
FDA Device · Class II · 2016-08-17 · Siemens Medical Solutions Usa - Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to…
FDA Device · Class II · 2016-08-17 · Teleflex Medical - Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standa…
FDA Device · Class II · 2016-08-17 · Stryker Howmedica Osteonics - Volker 2080, 2082, S 280 and S 282 series beds with lateral release button
FDA Device · Class II · 2016-08-17 · Hill Rom - Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-r…
FDA Device · Class II · 2016-08-17 · Philips Medical Systems Cleveland - Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction o…
FDA Device · Class II · 2016-08-17 · Philips Medical Systems Cleveland - Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218
FDA Device · Class II · 2016-08-17 · Integra Lifesciences - lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16
FDA Device · Class II · 2016-08-17 · Invacare - Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstru…
FDA Device · Class II · 2016-08-17 · Philips Medical Systems Cleveland - S3 MedSurg Bed, Model 3005
FDA Device · Class II · 2016-08-17 · Stryker Medical Division - Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a…
FDA Device · Class II · 2016-08-17 · Invacare - Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diag…
FDA Device · Class II · 2016-08-17 · Siemens Healthcare Diagnostics - Zyston¿ Transform Instrument Case
FDA Device · Class II · 2016-08-17 · Zimmer Biomet Spine - Ingenuity CT Model No. 728326
FDA Device · Class II · 2016-08-17 · Philips Medical Systems Cleveland - Zyston¿ Transform Implant Kit
FDA Device · Class II · 2016-08-17 · Zimmer Biomet Spine - EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Vete…
FDA Device · Class II · 2016-08-17 · Edan Diagnostics - Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstructi…
FDA Device · Class II · 2016-08-17 · Philips Medical Systems Cleveland - Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients
FDA Device · Class III · 2016-08-17 · C R Bard - OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, O…
FDA Device · Class II · 2016-08-17 · Ivoclar Vivadent - Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor…
FDA Device · Class II · 2016-08-17 · Invacare - Merge PACS software
FDA Device · Class II · 2016-08-17 · Merge Healthcare - MX 16-slice whole body computed tomography X-ray system
FDA Device · Class II · 2016-08-17 · Philips Medical Systems Cleveland - Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to pr…
FDA Device · Class II · 2016-08-17 · Invacare - STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Reloads…
FDA Device · Class II · 2016-08-17 · Intuitive Surgical - ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22 AXIOM Artis, Artis zee / zeego and Artis Q/ Q.ze…
FDA Device · Class II · 2016-08-17 · Siemens Medical Solutions Usa - Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system
FDA Device · Class II · 2016-08-17 · Topcon Medical Laser Systems - AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedic…
FDA Device · Class II · 2016-08-17 · Siemens Medical Solutions Usa - Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504)
FDA Device · Class II · 2016-08-17 · Halyard Health - ARTIS ZEE AND ZEEGO, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography sy…
FDA Device · Class II · 2016-08-17 · Siemens Medical Solutions Usa - Spirit Plus Bed, A-C Powered Hospital Bed
FDA Device · Class II · 2016-08-10 · Chg Hospital Beds - RePlant¿ Angled Abutment Part Number 6050-52-60
FDA Device · Class II · 2016-08-10 · Implant Direct Sybron Manufacturing - TWIST DR 25X95MM Cann 12MM Thd 30MM AO
FDA Device · Class II · 2016-08-10 · Zimmer - V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd
FDA Device · Class II · 2016-08-10 · Zimmer - Merge PACS software
FDA Device · Class II · 2016-08-10 · Merge Healthcare - Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01
FDA Device · Class II · 2016-08-10 · Zimmer Surgical - MultiDiagnost Eleva with Flat Detector
FDA Device · Class II · 2016-08-10 · Philips Electronics North America - SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that incl…
FDA Device · Class III · 2016-08-10 · C R Bard - Zimmer¿ Air Dermatome II Width Plate, 2 inch
FDA Device · Class II · 2016-08-10 · Zimmer Surgical - 91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B:…
FDA Device · Class II · 2016-08-10 · Spacelabs Healthcare - AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rap…
FDA Device · Class III · 2016-08-10 · Branan Medical - Synergy Spine
FDA Device · Class II · 2016-08-10 · Medtronic Navigation - Zimmer¿ Air Dermatome II Width Plate, 3 inch
FDA Device · Class II · 2016-08-10 · Zimmer Surgical - MACH Cranial Treon
FDA Device · Class II · 2016-08-10 · Medtronic Navigation - MACH AxiEM Cranial Treon
FDA Device · Class II · 2016-08-10 · Medtronic Navigation - AU480 Chemistry Analyzers, Reference No. B28624 The AU series are automated, clinical chemistry analyzers that measure analytes in patient…
FDA Device · Class II · 2016-08-10 · Beckman Coulter - V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd
FDA Device · Class II · 2016-08-10 · Zimmer - Mentor MemoryGel Breast Implant
FDA Device · Class II · 2016-08-10 · Mentor Texas - Zimmer¿ Air Dermatome II Width Plate, 1.5 inch
FDA Device · Class II · 2016-08-10 · Zimmer Surgical - Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00
FDA Device · Class II · 2016-08-10 · Zimmer Surgical - Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: Analytical X-Ray System X -Ray Fluorescence
FDA Device · Class II · 2016-08-10 · Olympus Scientific Solutions Americas - VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clin…
FDA Device · Class II · 2016-08-10 · Ortho Clinical Diagnostics - EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004
FDA Device · Class II · 2016-08-10 · Dako Denmark A S - Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing…
FDA Device · Class I · 2016-08-10 · Draeger Medical - BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for…
FDA Device · Class II · 2016-08-10 · B K Medical A S - 3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER C…
FDA Device · Class II · 2016-08-10 · Neocoil - Merge PACS software
FDA Device · Class II · 2016-08-10 · Merge Healthcare - Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile
FDA Device · Class II · 2016-08-10 · Teleflex Medical - Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes
FDA Device · Class II · 2016-08-10 · Medtronic Navigation - TWIST D 28X150MM CBS 45 Cann 14 MM AO
FDA Device · Class II · 2016-08-10 · Zimmer - Spirit Select Bed, A-C Powered Hospital Bed
FDA Device · Class II · 2016-08-10 · Chg Hospital Beds - UroDiagnost
FDA Device · Class II · 2016-08-10 · Philips Electronics North America - Zimmer¿ Air Dermatome II Width Plate, 4 inch
FDA Device · Class II · 2016-08-10 · Zimmer Surgical - FrameLink
FDA Device · Class II · 2016-08-10 · Medtronic Navigation - S7 MACH FrameLink
FDA Device · Class II · 2016-08-10 · Medtronic Navigation - MultiDiagnost Eleva
FDA Device · Class II · 2016-08-10 · Philips Electronics North America - 6F/7F MynxGrip Vascular Closure Device
FDA Device · Class II · 2016-08-10 · Accessclosure A Cardinal Health - IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for moni…
FDA Device · Class II · 2016-08-10 · Philips Electronics North America - Fusion ENT Application
FDA Device · Class II · 2016-08-10 · Medtronic Navigation - AU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated, clinical chemistry analyzers that measure analytes in patient…
FDA Device · Class II · 2016-08-10 · Beckman Coulter
Other years
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