Medical device recalls reported in 2019

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Reported	Recall	Class	Product	Firm
2019-12-04	Z-0579-2020	Class II	NC Emerge Monorail PTCA Dilatation Catheter	Boston Scientific Corporation
2019-12-04	Z-0580-2020	Class II	Rebel Monorail PtCr Coronary Stent System	Boston Scientific Corporation
2019-12-04	Z-0581-2020	Class II	Atellica CH 930 Analyzer	Siemens Healthcare Diagnostics, Inc.
2019-12-04	Z-0582-2020	Class II	PowerPort isp M	Bard Peripheral Vascular Inc
2019-12-04	Z-0583-2020	Class II	Behind-the-Ear hearing aids	GN Hearing A/S
2019-12-04	Z-0584-2020	Class II	In-the-Ear hearing aids	GN Hearing A/S
2019-12-04	Z-0585-2020	Class II	4Fr x 20cm Single Lumen CT Midline Basic Tray	Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
2019-11-27	Z-0025-2020	Class II	Monarch	AURIS HEALTH INC
2019-11-27	Z-0265-2020	Class II	SOMATOM go	Siemens Medical Solutions USA, Inc
2019-11-27	Z-0407-2020	Class II	EPISTAXIS TRAY Kit Code: MNS10165	Centurion Medical Products Corporation
2019-11-27	Z-0408-2020	Class II	YNHH SCOPE KIT Kit Code: MNS10475	Centurion Medical Products Corporation
2019-11-27	Z-0409-2020	Class II	NOSEBLEED TRAY Kit Code: MNS3885	Centurion Medical Products Corporation
2019-11-27	Z-0411-2020	Class II	Starburst Talon Semi-Flex Electrosurgical Device	Angiodynamics Inc. (Navilyst Medical Inc.)
2019-11-27	Z-0412-2020	Class II	Randox Liquid Cardiac Controls Catalogue Number CQ5051	Randox Laboratories, Limited
2019-11-27	Z-0413-2020	Class II	Randox Liquid Cardiac Controls Catalogue Number CQ5052	Randox Laboratories, Limited
2019-11-27	Z-0414-2020	Class II	Randox Liquid Cardiac Controls Catalogue Numbers CQ5053	Randox Laboratories, Limited
2019-11-27	Z-0415-2020	Class II	Guardia Access Nano Embryo Transfer Catheter is use for transferring…	Cook Inc.
2019-11-27	Z-0416-2020	Class II	Guardia Access Embryo Transfer Catheter is used for transferring IVF…	Cook Inc.
2019-11-27	Z-0417-2020	Class II	Blanketrol III Hyper-Hypothermia System- body hypothermia system…	Cincinnati Sub-Zero Products LLC, a Gentherm Company
2019-11-27	Z-0418-2020	Class II	Blanketrol II Hyper-Hypothermia System	Cincinnati Sub-Zero Products LLC, a Gentherm Company
2019-11-27	Z-0419-2020	Class II	CoolBlue Hyper-Hypothermia System- body hypothermia system Model:…	Cincinnati Sub-Zero Products LLC, a Gentherm Company
2019-11-27	Z-0420-2020	Class II	EZ Glide Aortic Cannula	Edwards Lifesciences, LLC
2019-11-27	Z-0421-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0422-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0423-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0424-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0425-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0426-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0427-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0428-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0429-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0430-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0431-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0432-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0433-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0434-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0435-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0436-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0437-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0438-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0439-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0440-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0441-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0442-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0443-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0444-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0445-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0446-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0447-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0448-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0449-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0450-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0451-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0452-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0453-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0454-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0455-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0456-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0457-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0458-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0459-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0460-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0461-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0462-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0463-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0464-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0465-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0466-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0467-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0468-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0469-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0470-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0471-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0472-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0473-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0474-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0475-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0476-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0477-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0478-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0479-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0480-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0481-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0482-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0483-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0484-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0485-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0486-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0487-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0488-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0489-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0490-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0491-2020	Class II	Torcon NB Advantage Catheters	Cook Inc.
2019-11-27	Z-0492-2020	Class II	AutoMate 1250	Beckman Coulter Inc.
2019-11-27	Z-0493-2020	Class II	Singles carbides by Meisinger	Hager & Meisinger Gmbh
2019-11-27	Z-0494-2020	Class II	MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS	AMD Medicom Inc.
2019-11-27	Z-0495-2020	Class II	MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS	AMD Medicom Inc.
2019-11-27	Z-0496-2020	Class II	WECK AutoEndo5	Teleflex Medical
2019-11-27	Z-0497-2020	Class II	WECK Hem-O-Lok AutoEndo5	Teleflex Medical
2019-11-27	Z-0498-2020	Class II	HeartStart XL+ Defibrillator/Monitor	Philips North America, LLC
2019-11-27	Z-0499-2020	Class II	BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547	Becton Dickinson & Company
2019-11-27	Z-0500-2020	Class II	BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575	Becton Dickinson & Company
2019-11-27	Z-0501-2020	Class II	BIOFLO 8F SINGLE PLASTIC FILLED	Angiodynamics Inc. (Navilyst Medical Inc.)
2019-11-27	Z-0502-2020	Class II	BIOFLO 8F SINGLE TITANIUM NON- FILLED	Angiodynamics Inc. (Navilyst Medical Inc.)
2019-11-27	Z-0503-2020	Class II	BIOFLO 8F SINGLE PLASTIC NON-FILLED	Angiodynamics Inc. (Navilyst Medical Inc.)
2019-11-27	Z-0504-2020	Class II	BIOFLO 8F SINGLE PLASTIC FILLED	Angiodynamics Inc. (Navilyst Medical Inc.)
2019-11-27	Z-0505-2020	Class II	XCELA	Angiodynamics Inc. (Navilyst Medical Inc.)
2019-11-27	Z-0506-2020	Class II	Pneumothorax Tray	Cook Inc.
2019-11-27	Z-0507-2020	Class II	The PolarCath Balloon Catheter consists of a coaxial catheter shaft…	Nucryo Vascular Inc.
2019-11-27	Z-0509-2020	Class II	Epix Electrosurgical Probes with Smoke Evacuation	Applied Medical Resources Corp
2019-11-27	Z-0510-2020	Class II	GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical…	Applied Medical Resources Corp
2019-11-27	Z-0511-2020	Class II	Neocis Guidance System Fiducial Array	Neocis Inc.
2019-11-20	Z-0348-2020	Class II	Energy FX: a) original Aluminum	Basic Reset Inc.
2019-11-20	Z-0349-2020	Class II	MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm…	Synthes (USA) Products LLC
2019-11-20	Z-0350-2020	Class II	Universal Sexual Health Testing Kit	Privapath Diagnostics Ltd
2019-11-20	Z-0351-2020	Class II	LAG SCREW 3	Smith & Nephew, Inc.
2019-11-20	Z-0352-2020	Class II	ProtectIV¿ Plus Safety IV Catheter	Smiths Medical ASD Inc.
2019-11-20	Z-0353-2020	Class II	2000 Vascular with 30 Degree option	Heritage Medical Products, Inc.
2019-11-20	Z-0354-2020	Class II	EndoTool SubQ	Monarch Medical Technologies
2019-11-20	Z-0355-2020	Class II	TriMed Countersink 1	TriMed Inc.
2019-11-20	Z-0356-2020	Class II	TriMed Locking Drill Guide	TriMed Inc.
2019-11-20	Z-0357-2020	Class II	TriMed Hex Driver 1	TriMed Inc.
2019-11-20	Z-0358-2020	Class II	TriMed Peg Guide Extender	TriMed Inc.
2019-11-20	Z-0359-2020	Class II	TriMed Wrist Hook Dorsal Impactor	TriMed Inc.
2019-11-20	Z-0360-2020	Class II	Infinix DP- i	Canon Medical System, USA, INC.
2019-11-20	Z-0361-2020	Class II	2	Exactech, Inc.
2019-11-20	Z-0362-2020	Class II	TECOTHERM NEO	Tec Com Gmbh
2019-11-20	Z-0363-2020	Class II	Implant Direct	Implant Direct Sybron Manufacturing, LLC
2019-11-20	Z-0364-2020	Class II	Implant Direct	Implant Direct Sybron Manufacturing, LLC
2019-11-20	Z-0365-2020	Class II	Cadence Science Pressure Control Glass Syringe	Cadence Science, Inc.
2019-11-20	Z-0366-2020	Class II	TriMed Olecranon Hook Plate	TriMed Inc.
2019-11-20	Z-0367-2020	Class III	RANDOX NEFA	Randox Laboratories, Limited
2019-11-20	Z-0368-2020	Class II	Lemon Prep: MD0019T	Carroll-Baccari, Inc.
2019-11-20	Z-0369-2020	Class II	Pedia Prep: MD0033T	Carroll-Baccari, Inc.
2019-11-20	Z-0370-2020	Class II	CORFLO* Percutaneous Endoscopic Gastrostomy	Avanos Medical, Inc.
2019-11-20	Z-0371-2020	Class II	CORFLO* Percutaneous Endoscopic Gastrostomy	Avanos Medical, Inc.
2019-11-20	Z-0372-2020	Class II	Infinity M300 telemetry monitoring device Software versions VG2	Draegar Medical Systems, Inc.
2019-11-20	Z-0373-2020	Class II	ORTHOFIX Catalogue Number: ref 11007	Orthofix Srl
2019-11-20	Z-0374-2020	Class II	ORTHOFIX Catalogue Number: ref 13550	Orthofix Srl
2019-11-20	Z-0375-2020	Class II	ORTHOFIX Catalogue Number: ref 1100101	Orthofix Srl
2019-11-20	Z-0376-2020	Class II	ORTHOFIX Catalogue Number: ref 1100201	Orthofix Srl
2019-11-20	Z-0377-2020	Class II	ORTHOFIX Catalogue Number: ref 1100301	Orthofix Srl
2019-11-20	Z-0378-2020	Class II	ORTHOFIX Catalogue Number: ref 1100701	Orthofix Srl
2019-11-20	Z-0379-2020	Class II	ORTHOFIX Catalogue Number: ref 1355001	Orthofix Srl
2019-11-20	Z-0380-2020	Class II	ORTHOFIX Catalogue Number: ref 1-1100101	Orthofix Srl
2019-11-20	Z-0381-2020	Class II	ORTHOFIX Catalogue Number: ref 1-1100201	Orthofix Srl
2019-11-20	Z-0382-2020	Class II	ORTHOFIX Catalogue Number: ref 1-1100301	Orthofix Srl
2019-11-20	Z-0383-2020	Class II	ORTHOFIX Catalogue Number: ref 1-1100701	Orthofix Srl
2019-11-20	Z-0384-2020	Class II	ORTHOFIX Catalogue Number: ref 1-1300301	Orthofix Srl
2019-11-20	Z-0385-2020	Class II	ORTHOFIX Catalogue Number: ref 1-1355001	Orthofix Srl
2019-11-20	Z-0386-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-36501	Orthofix Srl
2019-11-20	Z-0387-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-91600UE	Orthofix Srl
2019-11-20	Z-0388-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-91647	Orthofix Srl
2019-11-20	Z-0389-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-91647UE	Orthofix Srl
2019-11-20	Z-0390-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-92501	Orthofix Srl
2019-11-20	Z-0391-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-92502	Orthofix Srl
2019-11-20	Z-0392-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-92503	Orthofix Srl
2019-11-20	Z-0393-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-92504	Orthofix Srl
2019-11-20	Z-0394-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-93501	Orthofix Srl
2019-11-20	Z-0395-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-93501JP	Orthofix Srl
2019-11-20	Z-0396-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-93501US	Orthofix Srl
2019-11-20	Z-0397-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-93502	Orthofix Srl
2019-11-20	Z-0398-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-93502JP	Orthofix Srl
2019-11-20	Z-0399-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-93502US	Orthofix Srl
2019-11-20	Z-0400-2020	Class II	ORTHOFIX Catalogue Number: ref:99-93503	Orthofix Srl
2019-11-20	Z-0401-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-93503US	Orthofix Srl
2019-11-20	Z-0402-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-93504	Orthofix Srl
2019-11-20	Z-0403-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-93601	Orthofix Srl
2019-11-20	Z-0404-2020	Class II	Visual-ICE Cryoablation System	Galil Medical, Inc.
2019-11-20	Z-0405-2020	Class II	Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A…	Tornier, Inc
2019-11-20	Z-0406-2020	Class II	Software versions syngo CT VB20 running on the following Siemens…	Siemens Medical Solutions USA, Inc
2019-11-13	Z-0009-2020	Class I	Babi	TELEFLEX-MORRISVILLE
2019-11-13	Z-0172-2020	Class I	Rosa Brain 3	MEDTECH SAS
2019-11-13	Z-0177-2020	Class I	Minimed Model 500 Remote Control	Medtronic Inc.
2019-11-13	Z-0178-2020	Class I	Minimed Model 503 Remote Transmitter	Medtronic Inc.
2019-11-13	Z-0213-2020	Class I	Forte Gamma Camera System is intended to produce images depicting the…	Philips Medical Systems (Cleveland) Inc
2019-11-13	Z-0214-2020	Class I	Forte Gamma Camera System is intended to produce images depicting the…	Philips Medical Systems (Cleveland) Inc
2019-11-13	Z-0215-2020	Class I	Forte Gamma Camera System is intended to produce images depicting the…	Philips Medical Systems (Cleveland) Inc
2019-11-13	Z-0216-2020	Class I	Forte Gamma Camera System is intended to produce images depicting the…	Philips Medical Systems (Cleveland) Inc
2019-11-13	Z-0217-2020	Class I	Forte Gamma Camera System is intended to produce images depicting the…	Philips Medical Systems (Cleveland) Inc
2019-11-13	Z-0263-2020	Class II	Autoject EI	Owen Mumford USA, Inc.
2019-11-13	Z-0264-2020	Class II	Petfine Auto Injector	Owen Mumford USA, Inc.
2019-11-13	Z-0266-2020	Class II	Low Level Output Cable Interface to Philips Monitor For Use With…	Datascope Corp.
2019-11-13	Z-0267-2020	Class II	VITROS chemistry Products Cl- Slides	Ortho-Clinical Diagnostics
2019-11-13	Z-0268-2020	Class II	VITROS chemistry Products Cl- Slides	Ortho-Clinical Diagnostics
2019-11-13	Z-0269-2020	Class II	VITROS chemistry Products K+ Slides	Ortho-Clinical Diagnostics
2019-11-13	Z-0270-2020	Class II	SCFE	Pega Medical Inc.
2019-11-13	Z-0271-2020	Class II	Hitachi Scenaria Whole-body X-ray CT System	Hitachi Medical Systems America Inc
2019-11-13	Z-0272-2020	Class II	Cardinal Health Brand 120mL/53mm sterile specimen container with…	Thermo Fisher Scientific (Monterrey)
2019-11-13	Z-0273-2020	Class II	Cardinal Health Brand 120mL/53mm sterile	Thermo Fisher Scientific (Monterrey)
2019-11-13	Z-0274-2020	Class II	StemPro¿ MSC SFM CTS"	Life Technologies Corporation
2019-11-13	Z-0275-2020	Class II	CTSTM Essential 8 Medium	Life Technologies Corporation
2019-11-13	Z-0276-2020	Class II	Prismaflex Control Unit	Baxter Healthcare Corporation
2019-11-13	Z-0277-2020	Class II	Prismaflex Control Unit	Baxter Healthcare Corporation
2019-11-13	Z-0278-2020	Class II	Prismaflex Control Unit	Baxter Healthcare Corporation
2019-11-13	Z-0279-2020	Class II	Prismaflex Control Unit	Baxter Healthcare Corporation
2019-11-13	Z-0280-2020	Class II	Prismaflex Control Unit	Baxter Healthcare Corporation
2019-11-13	Z-0281-2020	Class II	Giraffe OmniBed Carestation CS1	GE Healthcare, LLC
2019-11-13	Z-0282-2020	Class II	Rheumatoid Factor Standard	Randox Laboratories Ltd.
2019-11-13	Z-0283-2020	Class II	Liquid Protein Calibrators	Randox Laboratories Ltd.

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