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.
- Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient manner for use in a general clinical procedure
FDA Device · Class II · 2017-04-19 · Windstone Medical Packaging - Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA
FDA Device · Class II · 2017-04-19 · Ge Healthcare - Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus
FDA Device · Class II · 2017-04-19 · Draegar Medical Systems - PRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a general clinical procedure
FDA Device · Class II · 2017-04-19 · Windstone Medical Packaging - Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analys…
FDA Device · Class II · 2017-04-19 · Raysearch Laboratories Ab - da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument
FDA Device · Class II · 2017-04-19 · Intuitive Surgical - Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD
FDA Device · Class II · 2017-04-19 · Ge Healthcare - Vitrectomy Pack, part number AMS4952 Product packaged in a convenient manner for use in a general clinical procedure
FDA Device · Class II · 2017-04-19 · Windstone Medical Packaging - Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a convenient manner for use in a general clinical procedure
FDA Device · Class II · 2017-04-19 · Windstone Medical Packaging - Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps
FDA Device · Class II · 2017-04-19 · 2k Innovations - Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
FDA Device · Class II · 2017-04-19 · Siemens Medical Solutions Usa - Ortho Basic Pack, part number AMS6459 Product packaged in a convenient manner for use in a general clinical procedure
FDA Device · Class II · 2017-04-19 · Windstone Medical Packaging - CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO
FDA Device · Class II · 2017-04-19 · Smiths Medical Asd - Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus
FDA Device · Class II · 2017-04-19 · Draegar Medical Systems - HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTI…
FDA Device · Class II · 2017-04-19 · Conmed - Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner for use in a general clinical procedure
FDA Device · Class II · 2017-04-19 · Windstone Medical Packaging - ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure
FDA Device · Class II · 2017-04-19 · Windstone Medical Packaging - Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps
FDA Device · Class II · 2017-04-19 · 2k Innovations - Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a convenient manner for use in a general clinical procedure
FDA Device · Class II · 2017-04-19 · Windstone Medical Packaging - Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps
FDA Device · Class II · 2017-04-19 · 2k Innovations - Volt Resistance Heated Lower Back Garment Deep penetrating heat garment and wraps
FDA Device · Class II · 2017-04-19 · 2k Innovations - Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps
FDA Device · Class II · 2017-04-19 · 2k Innovations - Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter
FDA Device · Class II · 2017-04-19 · Volcano - 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 - Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wraps
FDA Device · Class II · 2017-04-19 · 2k Innovations - MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used b…
FDA Device · Class II · 2017-04-19 · Zimmer Biomet - Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient manner for use in a general clinical procedure
FDA Device · Class II · 2017-04-19 · Windstone Medical Packaging - TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Number…
FDA Device · Class II · 2017-04-19 · Hill Rom - VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5…
FDA Device · Class II · 2017-04-19 · Ortho Clinical Diagnostics - Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-62…
FDA Device · Class II · 2017-04-19 · Nihon Kohden America - Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 St…
FDA Device · Class II · 2017-04-19 · Welch Allyn - VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family…
FDA Device · Class II · 2017-04-19 · Biomerieux - AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures…
FDA Device · Class II · 2017-04-19 · Aesculap Implant Systems - Custom Tray, part numbers PSS1111 and PSS1111(A. Product packaged in a convenient manner for use in a general clinical procedure
FDA Device · Class II · 2017-04-19 · Windstone Medical Packaging - Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general clinical procedure
FDA Device · Class II · 2017-04-19 · Windstone Medical Packaging - Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A. Product packaged in a convenient manner for use…
FDA Device · Class II · 2017-04-19 · Windstone Medical Packaging - Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and wraps
FDA Device · Class II · 2017-04-19 · 2k Innovations - The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis o…
FDA Device · Class II · 2017-04-19 · Merit Medical Systems - Merge Hemo software
FDA Device · Class II · 2017-04-19 · Merge Healthcare - Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps
FDA Device · Class II · 2017-04-19 · 2k Innovations - Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus
FDA Device · Class II · 2017-04-19 · Draegar Medical Systems - 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 - Eye Pack, part numbers WAL1085(B and WAL1085(C\ Product packaged in a convenient manner for use in a general clinical procedure
FDA Device · Class II · 2017-04-19 · Windstone Medical Packaging - Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189
FDA Device · Class II · 2017-04-19 · Windstone Medical Packaging - Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445
FDA Device · Class II · 2017-04-19 · Micromedics - Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammo…
FDA Device · Class II · 2017-04-19 · Ge Medical Systems Information T - Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure
FDA Device · Class II · 2017-04-19 · Windstone Medical Packaging - Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient manner for use in a general clinical procedure
FDA Device · Class II · 2017-04-19 · Windstone Medical Packaging - Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
FDA Device · Class II · 2017-04-19 · Boston Scientific - 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 - Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment and wraps
FDA Device · Class II · 2017-04-19 · 2k Innovations - Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
FDA Device · Class II · 2017-04-19 · Roche Diagnostics - Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat garment and wraps
FDA Device · Class II · 2017-04-19 · 2k Innovations - iConnect Enterprise Archive (ICEA) software
FDA Device · Class II · 2017-04-19 · Merge Healthcare - The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles o…
FDA Device · Class I · 2017-04-19 · Medtronic Neurosurgery - Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure
FDA Device · Class II · 2017-04-19 · Windstone Medical Packaging - Refinity Rotational Intravascular Ultrasound (IVUS) Catheter
FDA Device · Class II · 2017-04-19 · Volcano - Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wraps
FDA Device · Class II · 2017-04-19 · 2k Innovations - ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18
FDA Device · Class II · 2017-04-19 · Cardiovascular Systems - MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used…
FDA Device · Class II · 2017-04-19 · Zimmer Biomet - Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for si…
FDA Device · Class II · 2017-04-19 · Datascope - Keystone Dental Inc
FDA Device · Class II · 2017-04-19 · Keystone Dental - Specimen Gate Laboratory
FDA Device · Class II · 2017-04-19 · Perkinelmer Life And Analytical Sciences Wallac Oy - Minor Operation Kit, part number AMS1530 Product packaged in a convenient manner for use in a general clinical procedure
FDA Device · Class II · 2017-04-19 · Windstone Medical Packaging - eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical i…
FDA Device · Class II · 2017-04-12 · Philips Visicu - STAPLER,IS4000
FDA Device · Class II · 2017-04-12 · Intuitive Surgical - BrightView X 3/8 model number 882478 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging acc…
FDA Device · Class III · 2017-04-12 · Philips Medical Systems Cleveland - STAPLER,IS4000
FDA Device · Class II · 2017-04-12 · Intuitive Surgical - Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item Code: 3339 Curity Sodium Chloride Dressing is indi…
FDA Device · Class II · 2017-04-12 · Covidien - STAPLER,IS4000
FDA Device · Class II · 2017-04-12 · Intuitive Surgical - Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic…
FDA Device · Class II · 2017-04-12 · Beckman Coulter - OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer
FDA Device · Class II · 2017-04-12 · Centurion Medical Products - Bond Elut OMS (Dried Matrix Spotting)' Product
FDA Device · Class II · 2017-04-12 · Agilent Technologies - Mobile Diagnostic X-Ray System with Digital Panel
FDA Device · Class II · 2017-04-12 · Philips Healthcare - Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity sodium chloride dressing is saturated in a 20% hyp…
FDA Device · Class II · 2017-04-12 · Covidien - Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze an…
FDA Device · Class II · 2017-04-12 · Covidien - STAPLER,IS4000
FDA Device · Class II · 2017-04-12 · Intuitive Surgical - NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological speci…
FDA Device · Class II · 2017-04-12 · Biomerieux - Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride dressing is saturated in a 20% hypertonic sali…
FDA Device · Class II · 2017-04-12 · Covidien - POST-OP EYE TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer
FDA Device · Class II · 2017-04-12 · Centurion Medical Products - Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems ar…
FDA Device · Class II · 2017-04-12 · Beckman Coulter - Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinical Ch…
FDA Device · Class II · 2017-04-12 · Beckman Coulter - STAPLER,IS4000
FDA Device · Class II · 2017-04-12 · Intuitive Surgical - STAPLER,IS4000
FDA Device · Class II · 2017-04-12 · Intuitive Surgical - STAPLER,IS4000
FDA Device · Class II · 2017-04-12 · Intuitive Surgical - EYE KIT The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer
FDA Device · Class II · 2017-04-12 · Centurion Medical Products - ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, AL…
FDA Device · Class III · 2017-04-12 · Siemens Healthcare Diagnostics - Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity sodium chloride dressing is saturated in a 20% hyp…
FDA Device · Class II · 2017-04-12 · Covidien - STAPLER,IS4000
FDA Device · Class II · 2017-04-12 · Intuitive Surgical - Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile Item Code: 2841 The sterile eye pad is a device that consists of a…
FDA Device · Class II · 2017-04-12 · Covidien - DX-D600 - DXD Imaging Package
FDA Device · Class II · 2017-04-12 · Agfa Healthcare - Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is…
FDA Device · Class II · 2017-04-12 · Siemens Healthcare Diagnostics - OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer
FDA Device · Class II · 2017-04-12 · Centurion Medical Products - BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accom…
FDA Device · Class II · 2017-04-12 · Philips Medical Systems Cleveland - Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in…
FDA Device · Class II · 2017-04-12 · Siemens Healthcare Diagnostics - STAPLER,IS4000
FDA Device · Class II · 2017-04-12 · Intuitive Surgical - STAPLER,IS4000
FDA Device · Class II · 2017-04-12 · Intuitive Surgical - The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein
FDA Device · Class II · 2017-04-12 · Arrow International - STAPLER,IS4000
FDA Device · Class II · 2017-04-12 · Intuitive Surgical - BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging acc…
FDA Device · Class II · 2017-04-12 · Philips Medical Systems Cleveland
Other years
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