FDA Device · 2020
FDA Device recalls in 2020
RecallRadar indexes 3,055 FDA Device recall notices published in 2020. By classification: 182 Class I, 2,804 Class II, 69 Class III.
- Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT…
FDA Device · Class II · 2020-09-02 · Conformis - Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of gl…
FDA Device · Class II · 2020-09-02 · Materialise N V - ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿
FDA Device · Class II · 2020-09-02 · Globus Medical - System Model: Ultimax-i, DREX-UI80 (DREX-UI80)
FDA Device · Class II · 2020-09-02 · Canon Medical System Usa - Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination…
FDA Device · Class II · 2020-09-02 · Karl Storz Endoscopy - Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray im…
FDA Device · Class II · 2020-09-02 · Siemens Medical Solutions Usa - E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or o…
FDA Device · Class II · 2020-09-02 · Siemens Medical Solutions Usa - Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - Produ…
FDA Device · Class II · 2020-09-02 · Neurovision Medical Products - Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U, 0684-00-0470-07, 0684-00-…
FDA Device · Class II · 2020-09-02 · Datascope - Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02…
FDA Device · Class II · 2020-09-02 · Datascope - ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿
FDA Device · Class II · 2020-09-02 · Globus Medical - Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzo…
FDA Device · Class III · 2020-09-02 · Orasure Technologies - Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications F…
FDA Device · Class II · 2020-09-02 · Datascope - Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual: Z18444US - Product Usage: are intended to be used for examina…
FDA Device · Class II · 2020-09-02 · Karl Storz Endoscopy - ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿
FDA Device · Class II · 2020-09-02 · Globus Medical - ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿
FDA Device · Class II · 2020-09-02 · Globus Medical - LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging
FDA Device · Class II · 2020-09-02 · 89 North - Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications F…
FDA Device · Class II · 2020-09-02 · Datascope - ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿
FDA Device · Class II · 2020-09-02 · Globus Medical - Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use:…
FDA Device · Class II · 2020-09-02 · Datascope - ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿
FDA Device · Class II · 2020-09-02 · Globus Medical - Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray ima…
FDA Device · Class II · 2020-09-02 · Siemens Medical Solutions Usa - Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications F…
FDA Device · Class II · 2020-09-02 · Datascope - ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿
FDA Device · Class II · 2020-09-02 · Globus Medical - Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-…
FDA Device · Class II · 2020-09-02 · Datascope - VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only
FDA Device · Class II · 2020-09-02 · Ortho Clinical Diagnostics - RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, plannin…
FDA Device · Class II · 2020-09-02 · Raysearch Laboratories Ab - ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)
FDA Device · Class II · 2020-09-02 · Globus Medical - Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - Produc…
FDA Device · Class II · 2020-09-02 · Neurovision Medical Products - Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examina…
FDA Device · Class II · 2020-09-02 · Karl Storz Endoscopy - Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-0…
FDA Device · Class II · 2020-09-02 · Datascope - Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 068…
FDA Device · Class II · 2020-09-02 · Datascope - Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - Product Usage: For continuous EMG monitoring…
FDA Device · Class II · 2020-09-02 · Neurovision Medical Products - ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿
FDA Device · Class II · 2020-09-02 · Globus Medical - ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿
FDA Device · Class II · 2020-09-02 · Globus Medical - Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-…
FDA Device · Class II · 2020-09-02 · Datascope - ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿
FDA Device · Class II · 2020-09-02 · Globus Medical - BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack
FDA Device · Class II · 2020-09-02 · Becton Dickinson And - Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination…
FDA Device · Class II · 2020-09-02 · Karl Storz Endoscopy - Neurosign V4 Intraoperative Nerve monitor family of devices
FDA Device · Class II · 2020-09-02 · The Magstim - Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a m…
FDA Device · Class II · 2020-09-02 · Siemens Medical Solutions Usa - ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿
FDA Device · Class II · 2020-09-02 · Globus Medical - Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: B006LTE700L52$$7061318B - Product Usage: For continuous EMG moni…
FDA Device · Class II · 2020-09-02 · Neurovision Medical Products - CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilat…
FDA Device · Class II · 2020-09-02 · Ge Healthcare - Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection…
FDA Device · Class II · 2020-08-26 · Chembio Diagnostics - Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to t…
FDA Device · Class II · 2020-08-26 · Cytocell - Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of…
FDA Device · Class II · 2020-08-26 · Carefusion 303 - DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomie…
FDA Device · Class II · 2020-08-26 · Synthes Usa Products - POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is…
FDA Device · Class II · 2020-08-26 · Smith And Nephew Orthopaedics Ag - Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments
FDA Device · Class II · 2020-08-26 · Arjohuntleigh Polska Sp Z O O - Golden Technologies Model Number PR515 Lift Chair - Product Usage: is to provide lift assistance for persons who have difficulty rising fro…
FDA Device · Class II · 2020-08-26 · Golden Technologies - Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Monit…
FDA Device · Class II · 2020-08-26 · Philips North America - Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin…
FDA Device · Class II · 2020-08-26 · Chembio Diagnostics - Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site
FDA Device · Class II · 2020-08-26 · Smith And Nephew - Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary)
FDA Device · Class II · 2020-08-26 · Pharmaceutical Innovations - PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1
FDA Device · Class II · 2020-08-26 · Whirlpool - NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower ja…
FDA Device · Class II · 2020-08-26 · Nobel Biocare Services Ag - Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
FDA Device · Class II · 2020-08-26 · Olympus - Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of i…
FDA Device · Class II · 2020-08-26 · Carefusion 303 - Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 MRI Patient Monitorin…
FDA Device · Class II · 2020-08-26 · Philips North America - Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of in…
FDA Device · Class II · 2020-08-26 · Carefusion 303 - Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Pa…
FDA Device · Class II · 2020-08-26 · Philips North America - Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is inte…
FDA Device · Class II · 2020-08-26 · Shanghai United Imaging Healthcare - Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and…
FDA Device · Class II · 2020-08-26 · Chembio Diagnostics - Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of inf…
FDA Device · Class II · 2020-08-26 · Carefusion 303 - ClosureFast Micro Introducer Sheath Set, REF MIS-7F11
FDA Device · Class II · 2020-08-26 · Argon Medical Devices - Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the pr…
FDA Device · Class II · 2020-08-26 · Carefusion 303 - PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure
FDA Device · Class II · 2020-08-26 · Precision Valve And Automation - Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
FDA Device · Class II · 2020-08-26 · Olympus - Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of bo…
FDA Device · Class II · 2020-08-19 · Wright Medical Technology - Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a si…
FDA Device · Class II · 2020-08-19 · Luminex - Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright Medical hardware removal kit is designed to facilitate remova…
FDA Device · Class II · 2020-08-19 · Wright Medical Technology - Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and…
FDA Device · Class II · 2020-08-19 · Flower Orthopedics - Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage: intended to be used for internal fixation of fractures a…
FDA Device · Class II · 2020-08-19 · Flower Orthopedics - Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly tha…
FDA Device · Class II · 2020-08-19 · Arrow International - Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures an…
FDA Device · Class II · 2020-08-19 · Flower Orthopedics - NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection as…
FDA Device · Class II · 2020-08-19 · Arrow International - BRAINLAB Kick 2
FDA Device · Class II · 2020-08-19 · Brainlab Ag - OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intend…
FDA Device · Class II · 2020-08-19 · Neurologica - Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid¿ ACD is indicated for reducing the incidence of reherniatio…
FDA Device · Class II · 2020-08-19 · Intrinsic Therapeutics - uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to…
FDA Device · Class II · 2020-08-19 · Shanghai United Imaging Healthcare - Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and…
FDA Device · Class II · 2020-08-19 · Ion Beam Applications - PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients…
FDA Device · Class II · 2020-08-19 · Smith And Nephew - BRAINLAB Curve
FDA Device · Class II · 2020-08-19 · Brainlab Ag - Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be used for internal fixation of fractures and…
FDA Device · Class II · 2020-08-19 · Flower Orthopedics - STAT KIT Model 550AI Emergency Medical Kit
FDA Device · Class II · 2020-08-19 · Hf Acquisition - uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to a…
FDA Device · Class II · 2020-08-19 · Shanghai United Imaging Healthcare - HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150
FDA Device · Class II · 2020-08-19 · Hf Acquisition - Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX…
FDA Device · Class II · 2020-08-19 · Bioseal - STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support dev…
FDA Device · Class II · 2020-08-19 · Hf Acquisition - Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be used for internal fixation of fractures an…
FDA Device · Class II · 2020-08-19 · Flower Orthopedics - VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vi…
FDA Device · Class II · 2020-08-19 · Ortho Clinical Diagnostics - Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M353…
FDA Device · Class II · 2020-08-19 · Philips North America - AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search fo…
FDA Device · Class III · 2020-08-19 · Linet Americas - Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder…
FDA Device · Class II · 2020-08-19 · Maquet Cardiovascular Us Sales - STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan Nasal spray, item number 1010300
FDA Device · Class II · 2020-08-19 · Hf Acquisition - Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit permits access to the epidural s…
FDA Device · Class II · 2020-08-19 · Arrow International - Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be used for internal fixation of fractures an…
FDA Device · Class II · 2020-08-19 · Flower Orthopedics - Anjon Bremer Molded Crown. bone fixation fastener for spinal use
FDA Device · Class II · 2020-08-19 · Anjon Holdings - Tibial knee prosthesis
FDA Device · Class II · 2020-08-19 · Smith And Nephew
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)