FDA Device · 2017
FDA Device recalls in 2017
RecallRadar indexes 2,615 FDA Device recall notices published in 2017. By classification: 51 Class I, 2,510 Class II, 54 Class III.
- LARGE CRANIOTOME, BLACK MAX
FDA Device · Class II · 2017-05-10 · The Anspach Effort - Bearing Sleeve, 10CM Curved Product Usage: Pneumatic system
FDA Device · Class II · 2017-05-10 · The Anspach Effort - STANDARD CRANIOTOME, BLACK MAX
FDA Device · Class II · 2017-05-10 · The Anspach Effort - If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products are sterile dressings used as an insulation barrier between the Pola…
FDA Device · Class II · 2017-05-10 · Breg - 5.0cm Short Attachment
FDA Device · Class II · 2017-05-10 · The Anspach Effort - SMALL ATTACHMENT, JACOBS CHUCK
FDA Device · Class II · 2017-05-10 · The Anspach Effort - 6.8cm Controlled Depth Attachment Product Usage: Pneumatic system
FDA Device · Class II · 2017-05-10 · The Anspach Effort - IMRI SHORT HD ATTACHMENT Product Usage: Pneumatic system
FDA Device · Class II · 2017-05-10 · The Anspach Effort - eMax2 PLUS Product Usage: Electric system
FDA Device · Class II · 2017-05-10 · The Anspach Effort - Dressing Back, P/N 09810 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold ther…
FDA Device · Class II · 2017-05-10 · Breg - RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QTY: (1)
FDA Device · Class II · 2017-05-10 · Smith And Nephew - RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)
FDA Device · Class II · 2017-05-10 · Smith And Nephew - eMax2 Hybrid Hand Control Product Usage: Electric system
FDA Device · Class II · 2017-05-10 · The Anspach Effort - Bearing Sleeve, 10CM Straight Product Usage: Pneumatic system
FDA Device · Class II · 2017-05-10 · The Anspach Effort - Autolube-III Product Usage: Pneumatic system
FDA Device · Class II · 2017-05-10 · The Anspach Effort - 19CM ATTACHMENT, BLACK MAX
FDA Device · Class II · 2017-05-10 · The Anspach Effort - MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected
FDA Device · Class II · 2017-05-10 · Medtronic - GREEN ROTATING CRANIOTOME, BLACK MAX
FDA Device · Class II · 2017-05-10 · The Anspach Effort - ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready…
FDA Device · Class II · 2017-05-10 · Roho - AL-III-DISS Adapter Product Usage: Pneumatic system
FDA Device · Class II · 2017-05-10 · The Anspach Effort - RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)
FDA Device · Class II · 2017-05-10 · Smith And Nephew - AQUIOS CL Flow Cytometer, Ref no
FDA Device · Class II · 2017-05-10 · Beckman Coulter - SurFlo IV Catheter
FDA Device · Class II · 2017-05-10 · Terumo Medical - Sonesta S2
FDA Device · Class II · 2017-05-10 · Sonesta Medical Ab - Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care col…
FDA Device · Class II · 2017-05-10 · Breg - AL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic system
FDA Device · Class II · 2017-05-10 · The Anspach Effort - Autolube-III with 20ft hose Product Usage: Pneumatic system
FDA Device · Class II · 2017-05-10 · The Anspach Effort - Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of tot…
FDA Device · Class II · 2017-05-03 · Orthosoft - ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14
FDA Device · Class II · 2017-05-03 · Cardiovascular Systems - 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755…
FDA Device · Class II · 2017-05-03 · Amendia - VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Di…
FDA Device · Class II · 2017-05-03 · Ortho Clinical Diagnostics - uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to T…
FDA Device · Class II · 2017-05-03 · Ulrich Medical Usa - BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX) I Plate Product Us…
FDA Device · Class III · 2017-05-03 · Becton Dickinson And - The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for curved stairs
FDA Device · Class II · 2017-05-03 · Savaria Concord Lifts - SmartSite Add-On Bag Access Device, Model No. 10013365
FDA Device · Class II · 2017-05-03 · Carefusion 303 - Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood Agar is a solid medium…
FDA Device · Class II · 2017-05-03 · Remel - Stryker SmartLife Large Aseptic Housing (7126-120-000)
FDA Device · Class II · 2017-05-03 · Stryker Instruments Div - 18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C
FDA Device · Class II · 2017-05-03 · Siemens Medical Solutions Usa - HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an elect…
FDA Device · Class I · 2017-05-03 · Heartware - Omega Incline Platform Lift
FDA Device · Class II · 2017-05-03 · Savaria Concord Lifts - Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit
FDA Device · Class II · 2017-05-03 · Arrow International - HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation i…
FDA Device · Class I · 2017-05-03 · Heartware - 1 mL Medallion¿ Syringe
FDA Device · Class II · 2017-05-03 · Merit Medical Systems - 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420
FDA Device · Class II · 2017-05-03 · Xtant Medical - PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L…
FDA Device · Class II · 2017-04-26 · Cp Medical - Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 The ACUFEX TRUNAV Retrograde Drill is intended for use in creat…
FDA Device · Class II · 2017-04-26 · Smith And Nephew - various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee Syste…
FDA Device · Class II · 2017-04-26 · Zimmer Biomet - Proteus 235, Proton Therapy System
FDA Device · Class II · 2017-04-26 · Ion Beam Applications - INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight
FDA Device · Class II · 2017-04-26 · Ace Surgical Supply - Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 The ACUFEX TRUNAV Retrograde Drill is intended for use in creat…
FDA Device · Class II · 2017-04-26 · Smith And Nephew - Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 The ACUFEX TRUNAV Retrograde Drill is intended for use in creat…
FDA Device · Class II · 2017-04-26 · Smith And Nephew - Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10.5MM Product Number: 72204047 The ACUFEX TRUNAV Retrograde Drill is intended for use in cre…
FDA Device · Class II · 2017-04-26 · Smith And Nephew - Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
FDA Device · Class II · 2017-04-26 · Beckman Coulter - Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing,…
FDA Device · Class II · 2017-04-26 · Avid Medical - The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper FD1…
FDA Device · Class II · 2017-04-26 · Philips Electronics North America - Tapered SwissPlus Implant System, Model No. SPB10
FDA Device · Class II · 2017-04-26 · Zimmer Dental - various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option…
FDA Device · Class II · 2017-04-26 · Zimmer Biomet - NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
FDA Device · Class II · 2017-04-26 · Angiodynamics Navilyst Medical - D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic
FDA Device · Class II · 2017-04-26 · Smith And Nephew - D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692412…
FDA Device · Class II · 2017-04-26 · Smith And Nephew - various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System
FDA Device · Class II · 2017-04-26 · Zimmer Biomet - Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037 The ACUFEX TRUNAV Retrograde Drill is intended for use in crea…
FDA Device · Class II · 2017-04-26 · Smith And Nephew - Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medica…
FDA Device · Class II · 2017-04-26 · Alcon Research - Allura Xper Release 8.2 (Laird chiller is always installed)
FDA Device · Class II · 2017-04-26 · Philips Electronics North America - various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory
FDA Device · Class II · 2017-04-26 · Zimmer Biomet - Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM Product Number: 72204038 The ACUFEX TRUNAV Retrograde Drill is intended for use in creati…
FDA Device · Class II · 2017-04-26 · Smith And Nephew - Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043 The ACUFEX TRUNAV Retrograde Drill is intended for use in crea…
FDA Device · Class II · 2017-04-26 · Smith And Nephew - BD Viper LT software, version 3.00H
FDA Device · Class II · 2017-04-26 · Bd Diagnostic - 216 Wilson Frame Pads, Model # 5319-37
FDA Device · Class II · 2017-04-26 · Mizuho Osi - Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number: 72204040 The ACUFEX TRUNAV Retrograde Drill is intended for use in creati…
FDA Device · Class II · 2017-04-26 · Smith And Nephew - Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079
FDA Device · Class III · 2017-04-26 · Teleflex Medical - Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
FDA Device · Class II · 2017-04-26 · Signal Medical - Merge Eye Station and Merge Eye Care PACS
FDA Device · Class II · 2017-04-26 · Merge Healthcare - D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic
FDA Device · Class II · 2017-04-26 · Smith And Nephew - Hemotherm CE, model 400CE, Heater-Cooling Device
FDA Device · Class II · 2017-04-26 · Cincinnati Sub Zero Products - SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile
FDA Device · Class II · 2017-04-26 · C R Bard - It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg)
FDA Device · Class II · 2017-04-26 · Verathon - Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041 The ACUFEX TRUNAV Retrograde Drill is intended for use in crea…
FDA Device · Class II · 2017-04-26 · Smith And Nephew - Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set
FDA Device · Class II · 2017-04-26 · Cook - Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic
FDA Device · Class II · 2017-04-26 · Smith And Nephew - Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fluid flow directiona…
FDA Device · Class II · 2017-04-26 · Elcam Medical - SmartTools Knee System Orthopedic Stereotaxic Instrument
FDA Device · Class II · 2017-04-26 · Orthosoft - various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
FDA Device · Class II · 2017-04-26 · Zimmer Biomet - various polyethylene implants Custom parts Product Usage: Custom
FDA Device · Class II · 2017-04-26 · Zimmer Biomet - Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039 The ACUFEX TRUNAV Retrograde Drill is intended for use in crea…
FDA Device · Class II · 2017-04-26 · Smith And Nephew - NEODENT CM Intraoral Scanbody, Article Number: 108.139
FDA Device · Class II · 2017-04-26 · Instradent Usa - Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11.5MM Product Number: 72204049 The ACUFEX TRUNAV Retrograde Drill is intended for use in cre…
FDA Device · Class II · 2017-04-26 · Smith And Nephew - Software version 4.44A utilized on the BD MAX System
FDA Device · Class II · 2017-04-26 · Bd Life Sciences - Artis zee, Angiographic x-ray system
FDA Device · Class II · 2017-04-26 · Siemens Medical Solutions Usa - Ferno PROFlexx¿ Model 28Z Chair Cot
FDA Device · Class II · 2017-04-26 · Ferno Washington - Cordis S.M.A.R.T. Flex Vascular Stent System
FDA Device · Class II · 2017-04-26 · Cordis - UNIQ: UNIQ FD10 722026
FDA Device · Class II · 2017-04-26 · Philips Electronics North America - Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number: 72204044 The ACUFEX TRUNAV Retrograde Drill is intended for use in creati…
FDA Device · Class II · 2017-04-26 · Smith And Nephew - Valleylab Laparoscopic Handset
FDA Device · Class II · 2017-04-26 · Covidien Medtronic - Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9.5MM Product Number: 72204045 The ACUFEX TRUNAV Retrograde Drill is intended for use in crea…
FDA Device · Class II · 2017-04-26 · Smith And Nephew - Laerdal Compact Suction Unit ¿ 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml…
FDA Device · Class II · 2017-04-26 · Laerdal Medical - Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 The ACUFEX TRUNAV Retrograde Drill is intended for use in creati…
FDA Device · Class II · 2017-04-26 · Smith And Nephew - Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) car…
FDA Device · Class II · 2017-04-19 · Conmed - Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
FDA Device · Class II · 2017-04-19 · Roche Diagnostics - Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wraps
FDA Device · Class II · 2017-04-19 · 2k Innovations
Other years
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