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.
- PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
FDA Device · Class II · 2016-12-14 · Deroyal Industries - Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to provi…
FDA Device · Class II · 2016-12-14 · Philips Medical Systems Cleveland - Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenien…
FDA Device · Class II · 2016-12-14 · Angiodynamics Navilyst Medical - Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
FDA Device · Class II · 2016-12-14 · Ivoclar Vivadent - Ingenuity Core 128 728323
FDA Device · Class II · 2016-12-14 · Philips Medical Systems Cleveland - Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21
FDA Device · Class II · 2016-12-14 · Sorin Group Usa - 5000 Series Freedom Drivers
FDA Device · Class I · 2016-12-14 · Syncardia Systems - Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: VANTA Analytical X-Ray System
FDA Device · Class II · 2016-12-14 · Olympus Scientific Solutions Americas - Magnesium on RX Imola analyser IVD
FDA Device · Class II · 2016-12-14 · Randox Laboratories - BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with EN…
FDA Device · Class II · 2016-12-14 · Angiodynamics Navilyst Medical - Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction o…
FDA Device · Class II · 2016-12-14 · Philips Medical Systems Cleveland - UltraSeal XT Plus Clear Refill
FDA Device · Class II · 2016-12-14 · Ultradent Products - Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenien…
FDA Device · Class II · 2016-12-14 · Angiodynamics Navilyst Medical - Multi-Med Single Lumen Catheters sold in Centurion convenience kits
FDA Device · Class I · 2016-12-14 · Centurion Medical Products - TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
FDA Device · Class II · 2016-12-14 · Deroyal Industries - MISAGO RX Self Expanding Peripheral Stem
FDA Device · Class II · 2016-12-07 · Terumo Medical - Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04…
FDA Device · Class I · 2016-12-07 · Greatbatch Medical - ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy…
FDA Device · Class II · 2016-12-07 · Teleflex Medical - Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
FDA Device · Class II · 2016-12-07 · Synthes Usa Products - Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BAX2, Unique Device Identifier G…
FDA Device · Class II · 2016-12-07 · Baxter Healthcare - Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664 For use with…
FDA Device · Class III · 2016-12-07 · Microport Orthopedics - Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262…
FDA Device · Class III · 2016-12-07 · Microport Orthopedics - Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA04714 For use with…
FDA Device · Class III · 2016-12-07 · Microport Orthopedics - Turbo Elite Atherectomy Catheter
FDA Device · Class II · 2016-12-07 · Spectranetics - V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE:…
FDA Device · Class II · 2016-12-07 · Baxter Healthcare - Adiprep Adipose Transfer System
FDA Device · Class II · 2016-12-07 · Terumo Bct - Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pedia…
FDA Device · Class II · 2016-12-07 · Hamilton Medical - Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113
FDA Device · Class II · 2016-12-07 · Siemens Medical Solutions Usa - Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26000023, 26000024, 26000025, 26000026, 260000…
FDA Device · Class III · 2016-12-07 · Microport Orthopedics - Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
FDA Device · Class II · 2016-12-07 · B Braun Medical - MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Ana…
FDA Device · Class II · 2016-12-07 · Roche Diagnostics Operations - ST¿CKERT HeaterCooler System 3T
FDA Device · Class II · 2016-12-07 · Sorin Group Usa - ELCA Coronary Atherectomy Catheter
FDA Device · Class II · 2016-12-07 · Spectranetics - OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow…
FDA Device · Class II · 2016-12-07 · Teleflex Medical - FMsealer Open Shears
FDA Device · Class II · 2016-12-07 · Domain Surgical - Monaco RTP System
FDA Device · Class II · 2016-12-07 · Elekta - sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique De…
FDA Device · Class II · 2016-12-07 · Baxter Healthcare - ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspir…
FDA Device · Class II · 2016-12-07 · Teleflex Medical - Bridge Occlusion Balloon
FDA Device · Class II · 2016-12-07 · Spectranetics - ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111
FDA Device · Class II · 2016-12-07 · Conformis - Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF DLCOGF42, REF DLCOGG44, REF DLCOGH48, REF DLCOGJ5…
FDA Device · Class III · 2016-12-07 · Microport Orthopedics - Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 38021158, REF 38021160, REF 380211…
FDA Device · Class III · 2016-12-07 · Microport Orthopedics - Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate conn…
FDA Device · Class II · 2016-12-07 · Merge Healthcare - Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy
FDA Device · Class II · 2016-12-07 · Elekta - ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bo…
FDA Device · Class II · 2016-12-07 · Teleflex Medical - Merge Hemo software
FDA Device · Class II · 2016-12-07 · Merge Healthcare - Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF…
FDA Device · Class III · 2016-12-07 · Microport Orthopedics - ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone mar…
FDA Device · Class II · 2016-12-07 · Teleflex Medical - Greatbatch Stiffer Coaxial Micro-Introducer
FDA Device · Class II · 2016-11-30 · Greatbatch Medical - The Hemotherm 400CE 115v, containing power board p/n 39945
FDA Device · Class II · 2016-11-30 · Cincinnati Sub Zero Products - Philips Healthcare System X-ray Tomography Computed
FDA Device · Class II · 2016-11-30 · Philips Electronics North America - Philips Healthcare System X-ray Tomography Computed
FDA Device · Class II · 2016-11-30 · Philips Electronics North America - Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium…
FDA Device · Class II · 2016-11-30 · Siemens Healthcare Diagnostics - LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended f…
FDA Device · Class II · 2016-11-30 · Diasorin - Waste Management Kit
FDA Device · Class II · 2016-11-30 · Merit Medical Systems - 2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile
FDA Device · Class II · 2016-11-30 · Synthes Usa Products - Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector
FDA Device · Class II · 2016-11-30 · Toshiba American Medical Systems - Manifold Kit
FDA Device · Class II · 2016-11-30 · Merit Medical Systems - 2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
FDA Device · Class II · 2016-11-30 · Synthes Usa Products - DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item Code: 186852026 The SKYLINE¿ Anterior Cervic…
FDA Device · Class II · 2016-11-30 · Depuy Spine - Extraction Hook - Sterile for TI Cannulated Nails
FDA Device · Class II · 2016-11-30 · Synthes Usa Products - Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31
FDA Device · Class II · 2016-11-30 · Merge Healthcare - Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
FDA Device · Class II · 2016-11-30 · Merit Medical Systems - Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intra…
FDA Device · Class II · 2016-11-30 · Synthes Usa Products - 3.0 mm Reaming Rod/950 mm, Sterile
FDA Device · Class II · 2016-11-30 · Synthes Usa Products - AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system
FDA Device · Class II · 2016-11-30 · Beckman Coulter - DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item Code: 186854018 The SKYLINE¿ Anterior Cervical…
FDA Device · Class II · 2016-11-30 · Depuy Spine - PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz
FDA Device · Class II · 2016-11-30 · Bausch And Lomb Irb - Fluid Management Set
FDA Device · Class II · 2016-11-30 · Merit Medical Systems - 2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
FDA Device · Class II · 2016-11-30 · Synthes Usa Products - 3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile
FDA Device · Class II · 2016-11-30 · Synthes Usa Products - DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186850018 The SKYLINE¿ Anterior Cerv…
FDA Device · Class II · 2016-11-30 · Depuy Spine - 3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
FDA Device · Class II · 2016-11-30 · Synthes Usa Products - DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item Code: 186862018 The SKYLINE¿ Anterior Cervi…
FDA Device · Class II · 2016-11-30 · Depuy Spine - Procedure Kit
FDA Device · Class II · 2016-11-30 · Merit Medical Systems - COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System
FDA Device · Class II · 2016-11-30 · Atricure - 2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
FDA Device · Class II · 2016-11-30 · Synthes Usa Products - DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item Code: 186852020 The SKYLINE¿ Anterior Cervic…
FDA Device · Class II · 2016-11-30 · Depuy Spine - Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system
FDA Device · Class II · 2016-11-30 · Merit Medical Systems - DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186852018 The SKYLINE¿ Anterior Cervi…
FDA Device · Class II · 2016-11-30 · Depuy Spine - Pathfast D-Dimer, Reference number: PF1051-KUS
FDA Device · Class II · 2016-11-30 · Lsi Medience - DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm Item Code: 186864018 The SKYLINE¿ Anterior Cervic…
FDA Device · Class II · 2016-11-30 · Depuy Spine - SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices
FDA Device · Class II · 2016-11-30 · Hologic - Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, E…
FDA Device · Class II · 2016-11-30 · Pentax - ACTIS Flex Reamers SZ 0/1
FDA Device · Class II · 2016-11-30 · Depuy Orthopaedics - TRANSPAC¿ IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML INTRAFLO¿ FLUSH (INFUSION PUMP), Item No. 42588-05 The Transp…
FDA Device · Class II · 2016-11-23 · Icu Medical - Transpac¿ IV Kit w/2 3-Way Stopcocks and 48" Pressure TBG, Item No. 46112-77 The Transpac Disposable Straight Pressure Transducer (DSPT) is…
FDA Device · Class II · 2016-11-23 · Icu Medical - iConnect Access software
FDA Device · Class II · 2016-11-23 · Merge Healthcare - TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM, Item No. 46097-62 The Transpac Disposable Straight Pressure Transducer (DSPT) i…
FDA Device · Class II · 2016-11-23 · Icu Medical - TRANSDUCER KIT FOR MEDICAL CTR. AT BOWLING GREEN, Item No. 46097-64 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extra…
FDA Device · Class II · 2016-11-23 · Icu Medical - Atrium Medical 24 Fr Trocar catheter, Sterile Model Number: 8424 Intended to facilitate the evacuation of air and/or fluid from the chest c…
FDA Device · Class II · 2016-11-23 · Atrium Medical - TRANSPAC¿ IV MONITORING KIT , 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MICRODRIP¿ (POLE MOUNT), Item No. 42608-05 The Transpac Dis…
FDA Device · Class II · 2016-11-23 · Icu Medical - ARTERIAL PRESSURE KIT W/03ML FLUSH DEVICE FOR LEBONHEUR CHILDRENS HOSP., Item No. 46091-31 The Transpac Disposable Straight Pressure Transd…
FDA Device · Class II · 2016-11-23 · Icu Medical - Transpac¿ IV Trifurcated Monitoring Kit 84" w/03 ml Squeeze Flush Device, Red, Blue and Yellow Stripe Tubing, Item No. 46113-90 The Transpa…
FDA Device · Class II · 2016-11-23 · Icu Medical - Transpac¿ IV Monitoring Kit w/ Safeset Reservoir, 24" Tubing,03 ml Intraflo¿ Flush and Needleless Valve, Item No. 46103-68 The Transpac Dis…
FDA Device · Class II · 2016-11-23 · Icu Medical - TRANSPAC¿ IV TRIFURCATED MONITORING KIT, 84" 3 DISPOSABLE TRANSDUCERS WITH 2 STOPCOCKS 3 3 ML SQUEEZE FLUSHES, MACRODRIP (POLE MOUNT), Item…
FDA Device · Class II · 2016-11-23 · Icu Medical - KIT FOR UNIVERSITY OF MICH. MOTT CATH LAB, Item No. 46061-49 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascula…
FDA Device · Class II · 2016-11-23 · Icu Medical - SINGLE A LINE KIT CC5 W/03ML FLUSH DEVICE FOR ALBERT EINSTEIN M.C., Item No. 46047-17 The Transpac Disposable Straight Pressure Transducer…
FDA Device · Class II · 2016-11-23 · Icu Medical - Monitoring Kit w/TP4, 03 ml Squeeze Flush, Blue Stripe Pressure Tubing, 3 Way Stopcocks, Blue Plugs and Needleless Valve, Item No. 46106-49…
FDA Device · Class II · 2016-11-23 · Icu Medical - Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or fluid from the chest ca…
FDA Device · Class II · 2016-11-23 · Atrium Medical
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)