Medical device recalls reported in 2020

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Reported	Recall	Class	Product	Firm
2020-12-30	Z-0591-2021	Class I	Flexor Check-Flo Introducer	Cook Inc.
2020-12-30	Z-0592-2021	Class I	Flexor Check-Flo Introducer	Cook Inc.
2020-12-30	Z-0593-2021	Class I	Flexor Check-Flo Introducer	Cook Inc.
2020-12-30	Z-0594-2021	Class I	Flexor Check-Flo Introducer	Cook Inc.
2020-12-30	Z-0595-2021	Class I	Flexor Check-Flo Introducer	Cook Inc.
2020-12-30	Z-0596-2021	Class I	Flexor Check-Flo Introducer	Cook Inc.
2020-12-30	Z-0597-2021	Class I	Flexor Check-Flo Introducer	Cook Inc.
2020-12-30	Z-0598-2021	Class I	Flexor Check-Flo Introducer	Cook Inc.
2020-12-30	Z-0599-2021	Class I	Flexor Check-Flo Introducer	Cook Inc.
2020-12-30	Z-0600-2021	Class I	Flexor Check-Flo Introducer	Cook Inc.
2020-12-30	Z-0601-2021	Class I	Flexor Check-Flo Introducer	Cook Inc.
2020-12-30	Z-0602-2021	Class I	Flexor Check-Flo Introducer	Cook Inc.
2020-12-30	Z-0603-2021	Class I	Flexor Check-Flo Introducer	Cook Inc.
2020-12-30	Z-0604-2021	Class I	Flexor Check-Flo Introducer	Cook Inc.
2020-12-30	Z-0605-2021	Class I	Flexor Check-Flo Introducer	Cook Inc.
2020-12-30	Z-0606-2021	Class I	Flexor Check-Flo Introducer	Cook Inc.
2020-12-30	Z-0607-2021	Class I	Flexor Check-Flo Introducer	Cook Inc.
2020-12-30	Z-0608-2021	Class I	Flexor Check-Flo Introducer	Cook Inc.
2020-12-30	Z-0609-2021	Class I	Flexor Check-Flo Introducer	Cook Inc.
2020-12-30	Z-0610-2021	Class I	Flexor Tuohy-Borst Side-Arm Introducer	Cook Inc.
2020-12-30	Z-0611-2021	Class I	Flexor Tuohy-Borst Side-Arm Introducer	Cook Inc.
2020-12-30	Z-0638-2021	Class II	Stimulan Kit 10cc	Biocomposites, Ltd.
2020-12-30	Z-0639-2021	Class II	STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R	GA HEALTH COMPANY LIMITED
2020-12-30	Z-0640-2021	Class II	STOPCON Disposable Valves Set-Single Use Valves	GA HEALTH COMPANY LIMITED
2020-12-30	Z-0641-2021	Class II	STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R	GA HEALTH COMPANY LIMITED
2020-12-30	Z-0642-2021	Class II	STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY:…	GA HEALTH COMPANY LIMITED
2020-12-30	Z-0643-2021	Class II	Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve	GA HEALTH COMPANY LIMITED
2020-12-30	Z-0644-2021	Class II	Andorate Disposable Endoscope Valves Set-Contains Suction	GA HEALTH COMPANY LIMITED
2020-12-30	Z-0645-2021	Class II	Andorate Disposable Endoscope Valves Set-5-piece Valve	GA HEALTH COMPANY LIMITED
2020-12-30	Z-0646-2021	Class II	Bulldog Disposable Endoscope Valves Set-Air/Water Valve	GA HEALTH COMPANY LIMITED
2020-12-30	Z-0647-2021	Class II	Bulldog Disposable Endoscope Valves Set-Air/Water Valve	GA HEALTH COMPANY LIMITED
2020-12-30	Z-0648-2021	Class II	ScopeValet Guardian Disposable Endoscope Valves Set Distributed By…	GA HEALTH COMPANY LIMITED
2020-12-30	Z-0649-2021	Class II	ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water	GA HEALTH COMPANY LIMITED
2020-12-30	Z-0650-2021	Class II	Infinity ACL Tibial Elbow Guide-indicated for use in open and…	ConMed Corporation
2020-12-30	Z-0651-2021	Class II	Infinity ACL Tibial Tip Guide- indicated for use in open and…	ConMed Corporation
2020-12-30	Z-0652-2021	Class II	CryoValve SG Pulmonary Human Heart Valve	CryoLife, Inc.
2020-12-30	Z-0653-2021	Class II	CryoPatch SG Pulmonary Human Cardiac Patch	CryoLife, Inc.
2020-12-30	Z-0654-2021	Class II	Star 8 Rolling Walker/Rollator	Nova Ortho-Med Inc
2020-12-30	Z-0655-2021	Class II	Viral Transport Medium	Hardy Diagnostics
2020-12-30	Z-0657-2021	Class II	IceFORCE" 2	Boston Scientific Corporation
2020-12-30	Z-0658-2021	Class II	IceFORCE" 2	Boston Scientific Corporation
2020-12-30	Z-0659-2021	Class II	IceFORCE" 2	Boston Scientific Corporation
2020-12-30	Z-0660-2021	Class II	IcePearl" 2	Boston Scientific Corporation
2020-12-30	Z-0661-2021	Class II	IcePearl" 2	Boston Scientific Corporation
2020-12-30	Z-0662-2021	Class II	IcePearl" 2	Boston Scientific Corporation
2020-12-30	Z-0663-2021	Class II	IceRod" 1	Boston Scientific Corporation
2020-12-30	Z-0664-2021	Class II	IceSphere" 1	Boston Scientific Corporation
2020-12-30	Z-0665-2021	Class II	IceRod" 1	Boston Scientific Corporation
2020-12-30	Z-0666-2021	Class II	IceRod" 1	Boston Scientific Corporation
2020-12-30	Z-0667-2021	Class II	IceRod" 1	Boston Scientific Corporation
2020-12-30	Z-0668-2021	Class II	IceRod" 1	Boston Scientific Corporation
2020-12-30	Z-0669-2021	Class II	IceRod" 1	Boston Scientific Corporation
2020-12-30	Z-0670-2021	Class II	IceSphere" 1	Boston Scientific Corporation
2020-12-30	Z-0671-2021	Class II	IceSphere" 1	Boston Scientific Corporation
2020-12-30	Z-0672-2021	Class II	IceSphere" 1	Boston Scientific Corporation
2020-12-30	Z-0673-2021	Class II	IceSphere" 1	Boston Scientific Corporation
2020-12-30	Z-0674-2021	Class II	IceSphere" 1	Boston Scientific Corporation
2020-12-30	Z-0675-2021	Class II	IceSeed" 1	Boston Scientific Corporation
2020-12-30	Z-0676-2021	Class II	IceSeed" 1	Boston Scientific Corporation
2020-12-30	Z-0677-2021	Class II	IceEDGE" 2	Boston Scientific Corporation
2020-12-30	Z-0678-2021	Class II	IceRod" 1	Boston Scientific Corporation
2020-12-30	Z-0679-2021	Class II	IceRod" 1	Boston Scientific Corporation
2020-12-30	Z-0680-2021	Class II	IceSeed" 1	Boston Scientific Corporation
2020-12-30	Z-0681-2021	Class II	IceSeed" 1	Boston Scientific Corporation
2020-12-30	Z-0682-2021	Class II	IceFORCE" 2	Boston Scientific Corporation
2020-12-30	Z-0683-2021	Class II	IcePearl" 2	Boston Scientific Corporation
2020-12-30	Z-0684-2021	Class II	Three IceFORCE" 2	Boston Scientific Corporation
2020-12-30	Z-0685-2021	Class II	Three IcePearl" 2	Boston Scientific Corporation
2020-12-30	Z-0686-2021	Class II	IceRod" i-Thaw" Prostate Cryoablation Kit	Boston Scientific Corporation
2020-12-30	Z-0687-2021	Class II	IceSeed" Prostate Cryoablation Kit	Boston Scientific Corporation
2020-12-30	Z-0688-2021	Class II	IceRod" Prostate Cryoablation Kit	Boston Scientific Corporation
2020-12-30	Z-0689-2021	Class II	Five IceSphere" Prostate Cryoablation Kit	Boston Scientific Corporation
2020-12-30	Z-0690-2021	Class II	Five IceRod" i-Thaw" Prostate Cryoablation Kit	Boston Scientific Corporation
2020-12-30	Z-0691-2021	Class II	IceRod" i-Thaw" Prostate Cryoablation Kit	Boston Scientific Corporation
2020-12-30	Z-0692-2021	Class II	IceSeed" Prostate Cryoablation Kit	Boston Scientific Corporation
2020-12-30	Z-0693-2021	Class II	IceRod" He-Thaw Prostate Cryoablation Kit	Boston Scientific Corporation
2020-12-30	Z-0694-2021	Class II	Revolution CT ES	GE Healthcare, LLC
2020-12-30	Z-0695-2021	Class II	Revolution CT with Apex Edition CT System	GE Healthcare, LLC
2020-12-30	Z-0696-2021	Class II	Spinal Rod Cutter	Zimmer Biomet, Inc.
2020-12-30	Z-0697-2021	Class II	Haag Streit Surgical Floor stands FS 2-11	Haag-Streit USA Inc
2020-12-30	Z-0698-2021	Class III	AMT Male ENFit-to-Stepped Male	Applied Medical Technology Inc
2020-12-30	Z-0699-2021	Class II	42 IN	ICU Medical, Inc.
2020-12-30	Z-0700-2021	Class II	Spinning Spiros	ICU Medical, Inc.
2020-12-30	Z-0701-2021	Class II	5 IN	ICU Medical, Inc.
2020-12-30	Z-0702-2021	Class II	30"	ICU Medical, Inc.
2020-12-30	Z-0703-2021	Class II	30"	ICU Medical, Inc.
2020-12-30	Z-0704-2021	Class II	3mL Syringe w/Spinning Spiros	ICU Medical, Inc.
2020-12-30	Z-0705-2021	Class II	30"	ICU Medical, Inc.
2020-12-30	Z-0706-2021	Class II	Spiros CLOSED MALE LUER w/RED CAP	ICU Medical, Inc.
2020-12-30	Z-0707-2021	Class II	31"	ICU Medical, Inc.
2020-12-30	Z-0708-2021	Class II	76 cm	ICU Medical, Inc.
2020-12-30	Z-0709-2021	Class II	Spinning Spiros Closed Male Luer	ICU Medical, Inc.
2020-12-30	Z-0710-2021	Class II	Appx 1	ICU Medical, Inc.
2020-12-30	Z-0711-2021	Class II	26 IN	ICU Medical, Inc.
2020-12-30	Z-0712-2021	Class II	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library	Baxter Healthcare Corporation
2020-12-30	Z-0713-2021	Class II	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library	Baxter Healthcare Corporation
2020-12-30	Z-0714-2021	Class II	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library	Baxter Healthcare Corporation
2020-12-30	Z-0715-2021	Class II	Baxter Spectrum IQ Infusion System with Dose IQ Safety Software	Baxter Healthcare Corporation
2020-12-30	Z-0716-2021	Class II	PryTime Medical	Prytime Medical Devices, Inc.
2020-12-30	Z-0717-2021	Class II	APEX Compounding System Control Panel Module	B Braun Medical, Inc.
2020-12-30	Z-0718-2021	Class II	APEX Compounding System Control Panel Module	B Braun Medical, Inc.
2020-12-30	Z-0719-2021	Class II	APEX Compounding System Control Panel Module	B Braun Medical, Inc.
2020-12-30	Z-0720-2021	Class II	MicroScan Pos MIC Panel Type 34	Beckman Coulter Inc.
2020-12-30	Z-0721-2021	Class II	ADVIA Gamma-Glutamyl Transferase	Siemens Healthcare Diagnostics, Inc.
2020-12-30	Z-0722-2021	Class II	Atellica Gamma-Glutamyl Transferase	Siemens Healthcare Diagnostics, Inc.
2020-12-30	Z-0723-2021	Class II	Vanguard 360 Revision System Posterior Augment With Bolt	Biomet, Inc.
2020-12-30	Z-0724-2021	Class II	Bactiseal Ventricular Catheter with Bactiseal Shunt System	Integra LifeSciences Corp.
2020-12-30	Z-0725-2021	Class II	Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed…	Integra LifeSciences Corp.
2020-12-23	Z-0564-2021	Class II	Tempus LS	Remote Diagnostic Technologies Ltd.
2020-12-23	Z-0565-2021	Class II	(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter…	Terumo Cardiovascular Systems Corporation
2020-12-23	Z-0566-2021	Class II	Microsurgical Operating Room Tables	Mizuho America, Inc.
2020-12-23	Z-0567-2021	Class II	Microsurgical Operating Room Tables	Mizuho America, Inc.
2020-12-23	Z-0568-2021	Class II	Centeze Centesis Catheter	Galt Medical Corporation
2020-12-23	Z-0569-2021	Class II	DABRA Laser	Ra Medical Systems, Inc.
2020-12-23	Z-0570-2021	Class II	Polaris 5	Zimmer Biomet, Inc.
2020-12-23	Z-0571-2021	Class II	DePuy Synthes 10	Synthes (USA) Products LLC
2020-12-23	Z-0572-2021	Class II	DePuy Synthes 10	Synthes (USA) Products LLC
2020-12-23	Z-0573-2021	Class II	DePuy Synthes 11	Synthes (USA) Products LLC
2020-12-23	Z-0574-2021	Class II	DePuy Synthes 11	Synthes (USA) Products LLC
2020-12-23	Z-0575-2021	Class II	DePuy Synthes 12	Synthes (USA) Products LLC
2020-12-23	Z-0576-2021	Class II	DePuy Synthes 12	Synthes (USA) Products LLC
2020-12-23	Z-0577-2021	Class II	DePuy Synthes 13	Synthes (USA) Products LLC
2020-12-23	Z-0578-2021	Class II	DePuy Synthes 13	Synthes (USA) Products LLC
2020-12-23	Z-0579-2021	Class II	DePuy Synthes 14	Synthes (USA) Products LLC
2020-12-23	Z-0580-2021	Class II	DePuy Synthes 14	Synthes (USA) Products LLC
2020-12-23	Z-0581-2021	Class II	DePuy Synthes 15	Synthes (USA) Products LLC
2020-12-23	Z-0582-2021	Class II	DePuy Synthes 15	Synthes (USA) Products LLC
2020-12-23	Z-0583-2021	Class II	DePuy Synthes 16	Synthes (USA) Products LLC
2020-12-23	Z-0584-2021	Class II	DePuy Synthes 16	Synthes (USA) Products LLC
2020-12-23	Z-0585-2021	Class II	DePuy Synthes 17	Synthes (USA) Products LLC
2020-12-23	Z-0586-2021	Class II	DePuy Synthes 17	Synthes (USA) Products LLC
2020-12-23	Z-0587-2021	Class II	DePuy Synthes 18	Synthes (USA) Products LLC
2020-12-23	Z-0588-2021	Class II	BD PrecisionGlide Needle 30G x 1/2	Becton Dickinson & Company
2020-12-23	Z-0589-2021	Class II	RayStation 4	RAYSEARCH LABORATORIES AB
2020-12-23	Z-0590-2021	Class II	InSure ONE Test Strips	Enterix, Inc.
2020-12-23	Z-0612-2021	Class II	Percept PC Implantable Neurostimulator	Medtronic Neuromodulation
2020-12-23	Z-0613-2021	Class II	Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038	Carl Zeiss Meditec AG
2020-12-23	Z-0614-2021	Class II	Carl Zeiss Meditec AG VISUREF150 REF 2227-967	Carl Zeiss Meditec AG
2020-12-23	Z-0615-2021	Class II	RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch	Medline Industries Inc
2020-12-23	Z-0616-2021	Class II	3	Biomet, Inc.
2020-12-23	Z-0617-2021	Class II	4	Biomet, Inc.
2020-12-23	Z-0618-2021	Class II	6	Biomet, Inc.
2020-12-23	Z-0619-2021	Class II	Comprehensive Reverse Shoulder System	Biomet, Inc.
2020-12-23	Z-0620-2021	Class II	Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System	Biomet, Inc.
2020-12-23	Z-0621-2021	Class II	Custom Cancellous Thread	Biomet, Inc.
2020-12-23	Z-0622-2021	Class II	M/H MODULAR STEM	Biomet, Inc.
2020-12-23	Z-0623-2021	Class II	OSS Polyethylene Tibial Bushing	Biomet, Inc.
2020-12-23	Z-0624-2021	Class II	Oxford Fixed Lateral	Biomet, Inc.
2020-12-23	Z-0625-2021	Class II	PHOENIX	Biomet, Inc.
2020-12-23	Z-0626-2021	Class II	RapidFire Clip	Biomet, Inc.
2020-12-23	Z-0627-2021	Class II	RINGLOC ACETABULAR SYSTEM Self-tapping bone screws	Biomet, Inc.
2020-12-23	Z-0628-2021	Class II	RINGLOC BIPOLAR Hip System Bi Polar Locking Ring	Biomet, Inc.
2020-12-23	Z-0629-2021	Class II	Sterile Trac System Thinflap 24 MM Burr Hole Plate	Biomet, Inc.
2020-12-23	Z-0630-2021	Class II	Titanium IFS	Biomet, Inc.
2020-12-23	Z-0631-2021	Class II	RingLoc+ Quick Connect Drill Bit	Biomet, Inc.
2020-12-23	Z-0632-2021	Class II	HLS Set Advanced Model Name: BEQ-HLS 5050 USA	Maquet Cardiovascular Us Sales, Llc
2020-12-23	Z-0633-2021	Class II	HLS Set Advanced	Maquet Cardiovascular Us Sales, Llc
2020-12-23	Z-0634-2021	Class II	Tina-quant C-Reactive Protein Gen	Roche Diagnostics Operations, Inc.
2020-12-23	Z-0635-2021	Class II	K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL…	Helena Laboratories, Corp.
2020-12-23	Z-0636-2021	Class II	Kowa VK-2s software Version 10	Kowa Optimed Inc
2020-12-23	Z-0637-2021	Class II	EKOS Control System	Boston Scientific Corporation
2020-12-16	Z-0534-2021	Class II	Shimadzu Mobile X-Ray System	Shimadzu Medical Systems
2020-12-16	Z-0535-2021	Class II	VNS Therapy SENTIVA DUO # 1000-D	LivaNova USA Inc
2020-12-16	Z-0536-2021	Class II	3PLUS1 Multilevel Plasma Calibrator Set	Chromsystems Instruments & Chemicals GmbH
2020-12-16	Z-0537-2021	Class II	MassChrom Amino Acid Analysis Plasma Control Level I	Chromsystems Instruments & Chemicals GmbH
2020-12-16	Z-0538-2021	Class II	MassChrom Amino Acid Analysis Plasma Control Level II	Chromsystems Instruments & Chemicals GmbH
2020-12-16	Z-0539-2021	Class II	MassChrom Amino Acid Analysis Plasma Control Level III	Chromsystems Instruments & Chemicals GmbH
2020-12-16	Z-0540-2021	Class II	CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector	Avanos Medical, Inc.
2020-12-16	Z-0541-2021	Class II	Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of…	Clinical Innovations, LLC
2020-12-16	Z-0542-2021	Class II	Everest MI XT Tab Removal Tool	K2M, Inc
2020-12-16	Z-0543-2021	Class II	MAC VU360	GE Healthcare, LLC
2020-12-16	Z-0544-2021	Class II	Philips IntelliVue X2 Multi measurement Server: M3002A	Philips North America Llc
2020-12-16	Z-0545-2021	Class II	Philips IntelliVue MP2 Patient Monitors	Philips North America Llc
2020-12-16	Z-0546-2021	Class II	Randox Mg R1	Randox Laboratories Ltd.
2020-12-16	Z-0547-2021	Class II	Randox Rx Series Mg	Randox Laboratories Ltd.
2020-12-16	Z-0548-2021	Class II	Instruction Manual for Mayfield A2000 Skull Cap	Integra LifeSciences Corp.
2020-12-16	Z-0549-2021	Class II	Canon Aquilion Prime SP	Canon Medical System, USA, INC.
2020-12-16	Z-0550-2021	Class II	PROKERA	TissueTech, Inc.
2020-12-16	Z-0551-2021	Class II	PROKERA Plus	TissueTech, Inc.
2020-12-16	Z-0552-2021	Class II	PROKERA Slim	TissueTech, Inc.
2020-12-16	Z-0553-2021	Class II	ELI 380 Electrocardiograph	WELCH ALLYN, INC/MORTARA
2020-12-16	Z-0554-2021	Class II	Bransist Safire	Shimadzu Medical Systems
2020-12-16	Z-0555-2021	Class II	Trinias	Shimadzu Medical Systems
2020-12-16	Z-0556-2021	Class II	MH-200S	Shimadzu Medical Systems
2020-12-16	Z-0557-2021	Class II	MANI TROCAR KIT 23G S	Mani, Inc. - Kiyohara Facility
2020-12-16	Z-0558-2021	Class II	MANI Infusion Cannula 23G S	Mani, Inc. - Kiyohara Facility
2020-12-16	Z-0559-2021	Class II	Evolut	Medtronic Heart Valves Division
2020-12-16	Z-0560-2021	Class II	Evolut	Medtronic Heart Valves Division
2020-12-16	Z-0561-2021	Class II	Evolut	Medtronic Heart Valves Division
2020-12-16	Z-0562-2021	Class II	BD" Multi-Check CD4 Low Control 2	Becton, Dickinson and Company, BD Biosciences
2020-12-16	Z-0563-2021	Class II	Sentinel V10	Spacelabs Healthcare, Ltd.
2020-12-09	Z-0498-2021	Class II	Olympus Ultrasound Endoscope	Olympus Corporation of the Americas
2020-12-09	Z-0499-2021	Class II	Olympus Ultrasound Endoscope	Olympus Corporation of the Americas
2020-12-09	Z-0500-2021	Class II	Olympus Ultrasound Endoscope	Olympus Corporation of the Americas
2020-12-09	Z-0501-2021	Class II	Olympus Ultrasound Endoscope	Olympus Corporation of the Americas
2020-12-09	Z-0502-2021	Class II	Olympus Ultrasound Endoscope	Olympus Corporation of the Americas
2020-12-09	Z-0503-2021	Class II	Olympus Ultrasound Endoscope	Olympus Corporation of the Americas
2020-12-09	Z-0504-2021	Class II	Olympus Ultrasound Endoscope	Olympus Corporation of the Americas
2020-12-09	Z-0505-2021	Class II	Olympus Ultrasound Endoscope	Olympus Corporation of the Americas
2020-12-09	Z-0506-2021	Class II	Olympus Ultrasound Endoscope	Olympus Corporation of the Americas

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