FDA Device · 2018
FDA Device recalls in 2018
RecallRadar indexes 3,757 FDA Device recall notices published in 2018. By classification: 136 Class I, 3,529 Class II, 92 Class III.
- MyLab Alpha, Model 7400
FDA Device · Class II · 2018-10-31 · Esaote S P A - O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, Model Number Bl7000002 7230 Product Usage: The O-arm Imaging Sy…
FDA Device · Class II · 2018-10-31 · Medtronic Navigation Littleton - CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc
FDA Device · Class II · 2018-10-31 · Nakanishi - APTIO 15000 REFRIGERATED STORAGE MODULE
FDA Device · Class II · 2018-10-31 · Siemens Healthcare Diagnostics - STREAMLAB - REFRIGERATED STORAGE MODULE 9000
FDA Device · Class II · 2018-10-31 · Siemens Healthcare Diagnostics - TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripher…
FDA Device · Class II · 2018-10-31 · Shimadzu Medical Systems Usa Com - APTIO RACK OUTPUT MODULE
FDA Device · Class II · 2018-10-31 · Siemens Healthcare Diagnostics - CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - APTIO RACK INPUT MODULE
FDA Device · Class II · 2018-10-31 · Siemens Healthcare Diagnostics - STREAMLAB CORE UNIT / LYNX WITH IOM
FDA Device · Class II · 2018-10-31 · Siemens Healthcare Diagnostics - CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, Model Number Bl70000027100 Product Usage: The O-arm Imaging Sys…
FDA Device · Class II · 2018-10-31 · Medtronic Navigation Littleton - Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revi…
FDA Device · Class II · 2018-10-31 · Medacta Usa - BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated…
FDA Device · Class II · 2018-10-31 · Biomerieux - CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007
FDA Device · Class I · 2018-10-31 · Alcon Research - CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-140XL GOWN, SPECIALTY XL…
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010
FDA Device · Class I · 2018-10-31 · Alcon Research - APTIO 9000 REFRIGERATED STORAGE MODULE
FDA Device · Class II · 2018-10-31 · Siemens Healthcare Diagnostics - Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouch level) - BF40181(Case box level) BF401…
FDA Device · Class II · 2018-10-31 · Micro Tech Nanjing - Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0,…
FDA Device · Class II · 2018-10-31 · Boston Scientific - Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transa…
FDA Device · Class II · 2018-10-31 · Canon Medical System Usa - O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl70000027GERR Product Usage: The O-arm Im…
FDA Device · Class II · 2018-10-31 · Medtronic Navigation Littleton - MyLab Gamma, Model 7410
FDA Device · Class II · 2018-10-31 · Esaote S P A - Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc
FDA Device · Class II · 2018-10-31 · Nakanishi - CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - MyLab Seven, Model 6400
FDA Device · Class II · 2018-10-31 · Esaote S P A - CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001
FDA Device · Class I · 2018-10-31 · Alcon Research - Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a…
FDA Device · Class II · 2018-10-31 · Smith And Nephew - VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvest…
FDA Device · Class II · 2018-10-31 · Terumo Cardiovascular Systems - CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - CHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple dru…
FDA Device · Class III · 2018-10-31 · Ameditech - (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Prod…
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - SIGNA Architect system Product Usage: The Signa Architect system is a whole body magnetic resonance scanner designed to support high resolu…
FDA Device · Class II · 2018-10-31 · Ge Medical Systems - CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - Altrix¿ Precision Temperature Management System Model: 8001Product Usage: The Altrix system is intended for circulating temperature control…
FDA Device · Class II · 2018-10-31 · Stryker Medical Division - Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinc…
FDA Device · Class II · 2018-10-31 · Ecolab - Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 7…
FDA Device · Class II · 2018-10-31 · Philips Medical Systems Dmc - CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for…
FDA Device · Class II · 2018-10-31 · Ge Medical Systems - O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 Product Usage: The O-arm Imaging System…
FDA Device · Class II · 2018-10-31 · Medtronic Navigation Littleton - Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc
FDA Device · Class II · 2018-10-31 · Nakanishi - CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - J-Plasma Precise 360, single use, disposable
FDA Device · Class II · 2018-10-31 · Bovie Medical - CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use
FDA Device · Class I · 2018-10-31 · Alcon Research - O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model Number Bl70000027100R Product Usage: The O-arm Imagi…
FDA Device · Class II · 2018-10-31 · Medtronic Navigation Littleton - NucliSENS¿ Magnetic Extraction Reagents
FDA Device · Class II · 2018-10-31 · Biomerieux - Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Su…
FDA Device · Class II · 2018-10-31 · Ecolab - GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2
FDA Device · Class II · 2018-10-31 · Ge Medical Systems - BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated…
FDA Device · Class II · 2018-10-31 · Biomerieux - CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Product Number: B9-15934B
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B
FDA Device · Class II · 2018-10-31 · Custom Healthcare Systems - O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R Product Usage: The O-arm Imagi…
FDA Device · Class II · 2018-10-31 · Medtronic Navigation Littleton - O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GER, Model Number Bl70000027GER Product Usage: The O-arm Imaging…
FDA Device · Class II · 2018-10-31 · Medtronic Navigation Littleton - Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da…
FDA Device · Class II · 2018-10-31 · Ecolab - 3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for…
FDA Device · Class II · 2018-10-31 · Synthes Usa Products - Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended…
FDA Device · Class II · 2018-10-31 · Nakanishi - O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 Product Usage: The O-arm Imaging Sys…
FDA Device · Class II · 2018-10-31 · Medtronic Navigation Littleton - Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc
FDA Device · Class II · 2018-10-31 · Nakanishi - Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use
FDA Device · Class II · 2018-10-24 · Life Technologies - CryoPatch SG Pulmonary Hemi-Artery, 1 graft
FDA Device · Class II · 2018-10-24 · Cryolife - Affixus Hip Fracture Nail Right 130 13 mm x 360 mm, Item Number 814513360 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Left 125 9 mm x 260 mm, Item Number 814409260 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: *ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.…
FDA Device · Class II · 2018-10-24 · Ge Medical Systems - Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
FDA Device · Class II · 2018-10-24 · Origen Biomedical - ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur system…
FDA Device · Class II · 2018-10-24 · Siemens Healthcare Diagnostics - Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as…
FDA Device · Class II · 2018-10-24 · Origen Biomedical - GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH…
FDA Device · Class II · 2018-10-24 · Ge Medical Systems - Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
FDA Device · Class II · 2018-10-24 · Besmed Health Business - Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number 814309380 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay
FDA Device · Class II · 2018-10-24 · Siemens Healthcare Diagnostics - Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141
FDA Device · Class II · 2018-10-24 · Life Technologies - Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
FDA Device · Class II · 2018-10-24 · Carl Zeiss Meditec Ag - Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB a…
FDA Device · Class II · 2018-10-24 · Siemens Healthcare Diagnostics - Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT systems are…
FDA Device · Class II · 2018-10-24 · Siemens Medical Solutions Usa - Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventric…
FDA Device · Class II · 2018-10-24 · Philips Electronics North America - Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as…
FDA Device · Class II · 2018-10-24 · Origen Biomedical - Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number 814611400 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Atellica Sample Handler Additional (SMN 11069004)
FDA Device · Class II · 2018-10-24 · Siemens Healthcare Diagnostics - Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as…
FDA Device · Class II · 2018-10-24 · Origen Biomedical - Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Atellica IM 1600 Analyzer (SMN 11066000)
FDA Device · Class II · 2018-10-24 · Siemens Healthcare Diagnostics - ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for us…
FDA Device · Class II · 2018-10-24 · Origen Biomedical - Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Multirall(TM) 200Liko Strap Gripper P/N 3136250 overhead lift for patient transfer situations
FDA Device · Class II · 2018-10-24 · Liko Ab
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)