FDA Device · 2015
FDA Device recalls in 2015
RecallRadar indexes 2,495 FDA Device recall notices published in 2015. By classification: 77 Class I, 2,300 Class II, 118 Class III.
- M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlus…
FDA Device · Class II · 2015-04-29 · Specialty Appliance Works - CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Left, REF CCP-LPX0L. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology - 6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids
FDA Device · Class II · 2015-04-29 · Churchill Medical Systems - CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology - Sony Medical Monitor LMD-1951MD 19 inch
FDA Device · Class II · 2015-04-29 · Sony Latin America - CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology - 8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluids
FDA Device · Class II · 2015-04-29 · Churchill Medical Systems - CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Left, REF CCP-HSX1L. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology - CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01
FDA Device · Class II · 2015-04-29 · Csa Medical - 6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administer medical fluids
FDA Device · Class II · 2015-04-29 · Churchill Medical Systems - HSG Trays/HS 5F Catheter Combo
FDA Device · Class II · 2015-04-29 · Catheter Research - 4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids
FDA Device · Class II · 2015-04-29 · Churchill Medical Systems - 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
FDA Device · Class II · 2015-04-29 · Churchill Medical Systems - Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44
FDA Device · Class II · 2015-04-29 · Exactech - Xpress System Pedicle Screw Assembly, 5.5 x 55mm
FDA Device · Class II · 2015-04-29 · X Spine Systems - CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology - CROSSCHECK(R) Plating system, Utility Plate, 3-Hole, REF CCP-UTN3. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology - DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reag…
FDA Device · Class II · 2015-04-29 · Diasorin - CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology - The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinici…
FDA Device · Class II · 2015-04-29 · Hospira - Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124
FDA Device · Class II · 2015-04-22 · Bard Peripheral Vascular - Artis Q/ Q zen systems
FDA Device · Class II · 2015-04-22 · Siemens Medical Solutions Usa - Replace Select Tapered TiU WP 5.0x10mm, Article No. 29423
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - OSSEOTITE Certain 2 Implant Rx only
FDA Device · Class II · 2015-04-22 · Biomet 3i - Replace Select Tapered TiU NP 3.5x13mm, Article No. 29402
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - LOW PROFILE NON-LOCK SCREW
FDA Device · Class II · 2015-04-22 · Biomet - NobelReplace CC PMC NP 3.5x13mm, Article No. 37288
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Produc…
FDA Device · Class II · 2015-04-22 · Baxter Healthcare - NobelReplace CC RP 4.3x8mm, Article No. 36704
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - Replace Select Tapered TiU NP 3.5x16mm, Article No. 29403
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - OSSEOTITE Tapered Certain Implant Rx Only
FDA Device · Class II · 2015-04-22 · Biomet 3i - 3i T3 Non-Platform Switched Tapered Implant Rx Only
FDA Device · Class II · 2015-04-22 · Biomet 3i - NobRpl Tapered Groovy 6.0mm 6x11.5mm, Article No. 36103
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - NobelReplace CC RP 5.0x8mm, Article No. 36710
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - NobelReplace CC RP 5.0x13mm, Article No. 36713
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - NobelReplace CC RP 4.3x11.5mm, Article No. 36707
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - Magellan Robotic System
FDA Device · Class II · 2015-04-22 · Hansen Medical - NobelReplace CC RP 5.0x10mm, Article No. 36711
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - NobelReplace CC RP 4.3x10mm, Article No. 36705
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels
FDA Device · Class II · 2015-04-22 · Bard Access Systems - NobelReplace CC NP 3.5x10mm, Article No. 36700
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - NobelReplace CC NP 3.5x11.5mm, Article No. 36701
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - NobelReplace CC RP 4.3x13mm, Article No. 36708
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - NobelReplace CC NP 3.5x13mm, Article No. 36702
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - Hardy Diagnostics cat no
FDA Device · Class II · 2015-04-22 · Hardy Diagnostics - Replace Select Tapered TiU WP 5.0x13mm, Article No. 29424
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with Larg…
FDA Device · Class II · 2015-04-22 · Natus Medical - NobelReplace CC PMC RP 4.3x10mm, Article No. 37291
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT…
FDA Device · Class II · 2015-04-22 · Vitrolife - NobelReplace CC PMC RP 4.3x8mm, Article No. 37290
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - NOBELREPLACE Tapered Groovy 6.0 6x8mm, Article No. 32223
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416
FDA Device · Class II · 2015-04-22 · Bard Peripheral Vascular - NobelReplace CC PMC RP 5.0x10mm, Article No. 37296
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - NobelReplace CC PMC RP 5.0x13mm, Article No. 37298
FDA Device · Class II · 2015-04-22 · Nobel Biocare Usa - Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable W…
FDA Device · Class II · 2015-04-22 · Integra Lifesciences - Talon Grasping Device, 160 cm, US endoscopy
FDA Device · Class II · 2015-04-22 · Us Endoscopy Group - Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems
FDA Device · Class II · 2015-04-22 · Ge Healthcare - WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001
FDA Device · Class II · 2015-04-22 · Coopersurgical - ProTrack Microcatheter
FDA Device · Class II · 2015-04-22 · Baylis Medical - da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack
FDA Device · Class II · 2015-04-15 · Intuitive Surgical - da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack
FDA Device · Class II · 2015-04-15 · Intuitive Surgical - CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 61…
FDA Device · Class II · 2015-04-15 · Civco Medical Instruments - da Vinci S Surgical System IS2000, Camera Drape, 20 Pack
FDA Device · Class II · 2015-04-15 · Intuitive Surgical - Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in c…
FDA Device · Class III · 2015-04-15 · Biomerieux - da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack
FDA Device · Class II · 2015-04-15 · Intuitive Surgical - Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clin…
FDA Device · Class III · 2015-04-15 · Biomerieux - da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack
FDA Device · Class II · 2015-04-15 · Intuitive Surgical - Instrument Kit for use with OsteoSponge SC grafts
FDA Device · Class II · 2015-04-15 · Bacterin International - da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack
FDA Device · Class II · 2015-04-15 · Intuitive Surgical - da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack
FDA Device · Class II · 2015-04-15 · Intuitive Surgical - CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray im…
FDA Device · Class II · 2015-04-15 · Carestream Health - CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant Heat Therapy Mattres…
FDA Device · Class II · 2015-04-15 · Coopersurgical - da Vinci S Surgical System IS2000, Arm Drape, 20 Pack
FDA Device · Class II · 2015-04-15 · Intuitive Surgical - da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack
FDA Device · Class II · 2015-04-15 · Intuitive Surgical - VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for…
FDA Device · Class II · 2015-04-15 · Vasonova - CS 8100 3D, CATALOG # (s): 5311162, 5311188
FDA Device · Class II · 2015-04-15 · Carestream Health - Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (opt…
FDA Device · Class I · 2015-04-15 · Lusys Laboratories - Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pa…
FDA Device · Class I · 2015-04-15 · Lusys Laboratories - Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Device 2. Lancet 3. Alcohol pad. 4. Develop buff…
FDA Device · Class I · 2015-04-15 · Lusys Laboratories - Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit
FDA Device · Class I · 2015-04-15 · Lusys Laboratories - Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad…
FDA Device · Class I · 2015-04-15 · Lusys Laboratories - da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack
FDA Device · Class II · 2015-04-15 · Intuitive Surgical - Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in c…
FDA Device · Class III · 2015-04-15 · Biomerieux - Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical
FDA Device · Class II · 2015-04-15 · Teleflex Medical - INFX-8000V Interventional Angiography System
FDA Device · Class II · 2015-04-15 · Toshiba American Medical Systems - ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT…
FDA Device · Class II · 2015-04-15 · Siemens Healthcare Diagnostics - da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack
FDA Device · Class II · 2015-04-15 · Intuitive Surgical - da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack
FDA Device · Class II · 2015-04-15 · Intuitive Surgical - Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad…
FDA Device · Class I · 2015-04-15 · Lusys Laboratories - da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack
FDA Device · Class II · 2015-04-15 · Intuitive Surgical - QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module
FDA Device · Class II · 2015-04-15 · Siemens Healthcare Diagnostics - ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH
FDA Device · Class II · 2015-04-15 · Tem Systems - Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit
FDA Device · Class I · 2015-04-15 · Lusys Laboratories - da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack
FDA Device · Class II · 2015-04-15 · Intuitive 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)