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Medical device recalls reported in 2020

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ReportedRecallClassProductFirm
2020-11-11Z-0410-2021Class IIIEND RING 15MM DIA/0 DEGSynthes (USA) Products LLC
2020-11-11Z-0411-2021Class IIIEND RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEGSynthes (USA) Products LLC
2020-11-11Z-0412-2021Class IIIEND RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEGSynthes (USA) Products LLC
2020-11-11Z-0413-2021Class IIIEND RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEGSynthes (USA) Products LLC
2020-11-11Z-0414-2021Class IIIEND RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEGSynthes (USA) Products LLC
2020-11-11Z-0415-2021Class IIISTANDARD RING 17MM X 22MMSynthes (USA) Products LLC
2020-11-11Z-0416-2021Class IIISTANDARD RING 22MM X 28MMSynthes (USA) Products LLC
2020-11-11Z-0417-2021Class III3Synthes (USA) Products LLC
2020-11-11Z-0418-2021Class IIAngiodynamics 5F Standard Micro-Introducer KitAngiodynamics, Inc.
2020-11-11Z-0419-2021Class IINovaplus Monitoriing Electrode with Foam Tape and Sticky Gel3M Company - Health Care Business
2020-11-11Z-0420-2021Class IINovaplus Monitoriing Electrode with Foam Tape and Sticky Gel3M Company - Health Care Business
2020-11-11Z-0421-2021Class II3M Red Dot Monitoring Electrode with 4mm Adapter3M Company - Health Care Business
2020-11-11Z-0422-2021Class II3M Red Dot Monitoring Electrode with Foam Tape3M Company - Health Care Business
2020-11-11Z-0423-2021Class II3M Red Dot Monitoring Electrode with Foam Tape3M Company - Health Care Business
2020-11-11Z-0424-2021Class IICovidien MONOJECT Standard Hypodermic NeedleCardinal Health 200, LLC
2020-11-04Z-0283-2021Class IIda Vinci Surgical SystemIntuitive Surgical, Inc.
2020-11-04Z-0284-2021Class IIPhilips Sterilizable Defibrillator PaddlesPhilips North America, LLC
2020-11-04Z-0285-2021Class IIPhilips Sterilizable Defibrillator PaddlesPhilips North America, LLC
2020-11-04Z-0286-2021Class IIHurricane RX Biliary Balloon Dilatation Catheter Catalog REF NoBoston Scientific Corporation
2020-11-04Z-0287-2021Class IIVisual-ICE MRI Cryoablation System Mobile Connection PanelBoston Scientific Corporation
2020-11-04Z-0288-2021Class IIInstructions For Use document of the GPS TrackersBlue Ortho
2020-11-04Z-0289-2021Class IIMerge LISMerge Healthcare, Inc.
2020-11-04Z-0290-2021Class IIGORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL SystemW L Gore & Associates, Inc.
2020-11-04Z-0291-2021Class IIGORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL SystemW L Gore & Associates, Inc.
2020-11-04Z-0292-2021Class II9372HD Digital CapturePentax of America Inc
2020-11-04Z-0293-2021Class II9310HD Digital Video Capture Module with software version 3Pentax of America Inc
2020-11-04Z-0294-2021Class IIBard 3F SL PowerMidline Basic Kit CE-indicated for short term access…Becton Dickinson & Company
2020-11-04Z-0295-2021Class IIBard 3F SL PowerMidline Full Kit CE-indicated for short term access…Becton Dickinson & Company
2020-11-04Z-0296-2021Class IILOM Disposable Surgical Gowns/Medical GownsTHREAD COUNSEL INC DBA LAWS OF MOTION
2020-11-04Z-0297-2021Class IIThe Quidel Triage BNP CalibratorsMedline Industries Inc
2020-11-04Z-0298-2021Class IISiemens Artis one systems with a Display Port…Siemens Medical Solutions USA, Inc
2020-11-04Z-0299-2021Class IIStreamline MIS Navigation System TapsRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
2020-11-04Z-0300-2021Class IIStreamline TL Navigation SystemRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
2020-11-04Z-0301-2021Class II5Smith & Nephew, Inc.
2020-11-04Z-0302-2021Class IIEach KWIK-STIK unit contains a lyophilized microorganism pelletMicrobiologics Inc
2020-11-04Z-0303-2021Class IIEach KWIK-STIK unit contains a lyophilized microorganism pelletMicrobiologics Inc
2020-11-04Z-0304-2021Class IIEach KWIK-STIK unit contains a lyophilized microorganism pelletMicrobiologics Inc
2020-11-04Z-0305-2021Class IICMEAmerica BodyGuard Wall Charger: Lot number 2019-0364CME America LLC
2020-11-04Z-0306-2021Class IIRevolution ApexGE Healthcare, LLC
2020-11-04Z-0307-2021Class IIEquinoxe Platform Fracture StemExactech, Inc.
2020-11-04Z-0308-2021Class IIEquinoxe Platform Fracture StemExactech, Inc.
2020-11-04Z-0309-2021Class IICritical Care Decontamination SystemBattelle Memorial Institute
2020-10-28Z-0087-2021Class IRashkind Balloon Septostomy CatheterMedtronic Vascular
2020-10-28Z-0088-2021Class IRashkind Balloon Septostomy CatheterMedtronic Vascular
2020-10-28Z-0089-2021Class IRashkind Balloon Septostomy CatheterMedtronic Vascular
2020-10-28Z-0110-2021Class ILangston Dual Lumen CatheterVascular Solutions, Inc.
2020-10-28Z-0111-2021Class ILangston Dual Lumen CatheterVascular Solutions, Inc.
2020-10-28Z-0112-2021Class ILangston Dual Lumen CatheterVascular Solutions, Inc.
2020-10-28Z-0113-2021Class ILangston Dual Lumen CatheterVascular Solutions, Inc.
2020-10-28Z-0114-2021Class ITrevo XP ProVue RetrieverStryker Neurovascular
2020-10-28Z-0115-2021Class IIAtellica IM HER-2/neuSiemens Healthcare Diagnostics, Inc
2020-10-28Z-0116-2021Class IIVICRYL MONOFILAMENT VIOLET 4INEthicon, Inc.
2020-10-28Z-0117-2021Class IIAltiVate Reverse Small Socket InsertEncore Medical, LP
2020-10-28Z-0118-2021Class IIGenesisSmith & Nephew, Inc.
2020-10-28Z-0119-2021Class IIOlympus CHF-CB30S Choledoscope Intended Use: The device was designed…Olympus Corporation of the Americas
2020-10-28Z-0120-2021Class IBaxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation
2020-10-28Z-0121-2021Class IBaxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation
2020-10-28Z-0122-2021Class IBaxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation
2020-10-28Z-0123-2021Class ISpectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation
2020-10-28Z-0124-2021Class IISofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a…Quidel Corporation
2020-10-28Z-0125-2021Class IIBD Nexiva Closed IV Catheter System Dual PortBecton Dickinson & Company
2020-10-28Z-0126-2021Class IIIMR Coils The MR Coil is intended to be used in conjunction with a…Invivo Corporation
2020-10-28Z-0127-2021Class IISystemGE Healthcare, LLC
2020-10-28Z-0128-2021Class IISystemGE Healthcare, LLC
2020-10-28Z-0129-2021Class IISystemGE Healthcare, LLC
2020-10-28Z-0130-2021Class IISystemGE Healthcare, LLC
2020-10-28Z-0131-2021Class IITomographic Imager Combining Emission Computed Tomography With…GE Healthcare, LLC
2020-10-28Z-0132-2021Class IIYuno Mobile Operating TableMaquet Cardiovascular Us Sales, Llc
2020-10-28Z-0133-2021Class IIYuno II Mobile Operating TableMaquet Cardiovascular Us Sales, Llc
2020-10-28Z-0134-2021Class IISiemens Dimension Vista Akaline PhosphataseSiemens Healthcare Diagnostics, Inc.
2020-10-28Z-0135-2021Class IIEMPOWR Acetabular System *** EMPOWR Acetabular CupEncore Medical, LP
2020-10-28Z-0136-2021Class IITWINFIX 5Smith & Nephew, Inc.
2020-10-28Z-0137-2021Class IITWINFIX 5Smith & Nephew, Inc.
2020-10-28Z-0138-2021Class IITWINFIX 5Smith & Nephew, Inc.
2020-10-28Z-0139-2021Class IITWINFIX 6Smith & Nephew, Inc.
2020-10-28Z-0140-2021Class IITWINFIX 6Smith & Nephew, Inc.
2020-10-28Z-0141-2021Class IITWINFIX AB 5Smith & Nephew, Inc.
2020-10-28Z-0142-2021Class IITWINFIX AB 5Smith & Nephew, Inc.
2020-10-28Z-0143-2021Class IIULTRA FAST-FIX AB ASSEMBLYSmith & Nephew, Inc.
2020-10-28Z-0144-2021Class IIULTRA FAST-FIX AB ASSEMBLYSmith & Nephew, Inc.
2020-10-28Z-0145-2021Class IIULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor…Smith & Nephew, Inc.
2020-10-28Z-0146-2021Class IIBIORAPTOR 2Smith & Nephew, Inc.
2020-10-28Z-0147-2021Class IIRAPTORMITE 3Smith & Nephew, Inc.
2020-10-28Z-0148-2021Class IIOSTEORAPTOR 2Smith & Nephew, Inc.
2020-10-28Z-0149-2021Class IIOSTEORAPTOR 2Smith & Nephew, Inc.
2020-10-28Z-0150-2021Class IIOSTEORAPTOR 2Smith & Nephew, Inc.
2020-10-28Z-0151-2021Class IIOSTEORAPTOR 2Smith & Nephew, Inc.
2020-10-28Z-0152-2021Class IIOSTEORAPTOR 2Smith & Nephew, Inc.
2020-10-28Z-0153-2021Class IIOSTEORAPTOR 2Smith & Nephew, Inc.
2020-10-28Z-0154-2021Class IIOSTEORAPTOR 2Smith & Nephew, Inc.
2020-10-28Z-0155-2021Class IITWINFIX ULTRA 5Smith & Nephew, Inc.
2020-10-28Z-0156-2021Class IITWINFIX ULTRA PLLA/HA 5Smith & Nephew, Inc.
2020-10-28Z-0157-2021Class IITWINFIX ULTRA 6Smith & Nephew, Inc.
2020-10-28Z-0158-2021Class IITWINFIX ULTRA PLLA/HA 6Smith & Nephew, Inc.
2020-10-28Z-0159-2021Class IITWINFIX ULTRA PLLA HA 4Smith & Nephew, Inc.
2020-10-28Z-0160-2021Class IITWINFIX ULTRA PLLA HA 5Smith & Nephew, Inc.
2020-10-28Z-0161-2021Class IITWINFIX ULTRA PLLA HA 6Smith & Nephew, Inc.
2020-10-28Z-0162-2021Class IITWINFIX ULTRA HA 4Smith & Nephew, Inc.
2020-10-28Z-0163-2021Class IITWINFIX ULTRA HA 5Smith & Nephew, Inc.
2020-10-28Z-0164-2021Class IITWINFIX ULTRA HA 6Smith & Nephew, Inc.
2020-10-28Z-0165-2021Class IIOSTEORAPTOR CRVD 2Smith & Nephew, Inc.
2020-10-28Z-0166-2021Class IIOSTEORAPTOR CRVD 2Smith & Nephew, Inc.
2020-10-28Z-0167-2021Class IIHEALICOIL RSB SA 4Smith & Nephew, Inc.
2020-10-28Z-0168-2021Class IIHEALICOIL RSB SA 4Smith & Nephew, Inc.
2020-10-28Z-0169-2021Class IIHEALICOIL RSB SA 4Smith & Nephew, Inc.
2020-10-28Z-0170-2021Class IIHEALICOIL RG SA 5Smith & Nephew, Inc.
2020-10-28Z-0171-2021Class IIHEALICOIL RG SA 5Smith & Nephew, Inc.
2020-10-28Z-0172-2021Class IIHEALICOIL RSB SA 5Smith & Nephew, Inc.
2020-10-28Z-0173-2021Class IIHEALICOIL RSB SA 5Smith & Nephew, Inc.
2020-10-28Z-0174-2021Class IIMICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor…Smith & Nephew, Inc.
2020-10-28Z-0175-2021Class IIMICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor…Smith & Nephew, Inc.
2020-10-28Z-0176-2021Class IIBien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOCBien-Air Surgery Sa
2020-10-28Z-0177-2021Class IIBien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL…Bien-Air Surgery Sa
2020-10-28Z-0178-2021Class IIBien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP FootcontrolBien-Air Surgery Sa
2020-10-28Z-0179-2021Class IIStryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT PedalBien-Air Surgery Sa
2020-10-28Z-0180-2021Class IIEntellus Medical REF SSA-102 SN ******* Shaver System Foot PedalBien-Air Surgery Sa
2020-10-28Z-0181-2021Class IIOpticross 35 15 MHz Peripheral Imaging Catheter 8FBoston Scientific Corporation
2020-10-28Z-0182-2021Class IINanoClave ConnectorICU Medical, Inc.
2020-10-28Z-0183-2021Class II6"ICU Medical, Inc.
2020-10-28Z-0184-2021Class II6"ICU Medical, Inc.
2020-10-28Z-0185-2021Class II5 INICU Medical, Inc.
2020-10-28Z-0186-2021Class II7"ICU Medical, Inc.
2020-10-28Z-0187-2021Class II7"ICU Medical, Inc.
2020-10-28Z-0188-2021Class II10"ICU Medical, Inc.
2020-10-28Z-0189-2021Class II9"ICU Medical, Inc.
2020-10-28Z-0190-2021Class II9 INICU Medical, Inc.
2020-10-28Z-0191-2021Class II5"ICU Medical, Inc.
2020-10-28Z-0192-2021Class II9ICU Medical, Inc.
2020-10-28Z-0193-2021Class II6ICU Medical, Inc.
2020-10-28Z-0194-2021Class II7"ICU Medical, Inc.
2020-10-28Z-0195-2021Class II109"ICU Medical, Inc.
2020-10-28Z-0196-2021Class II7ICU Medical, Inc.
2020-10-28Z-0197-2021Class II7"ICU Medical, Inc.
2020-10-28Z-0198-2021Class II107"ICU Medical, Inc.
2020-10-28Z-0199-2021Class II9ICU Medical, Inc.
2020-10-28Z-0200-2021Class II12 INICU Medical, Inc.
2020-10-28Z-0201-2021Class II7"ICU Medical, Inc.
2020-10-28Z-0202-2021Class II8"ICU Medical, Inc.
2020-10-28Z-0203-2021Class II8ICU Medical, Inc.
2020-10-28Z-0204-2021Class II6ICU Medical, Inc.
2020-10-28Z-0205-2021Class II9ICU Medical, Inc.
2020-10-28Z-0206-2021Class II60"ICU Medical, Inc.
2020-10-28Z-0207-2021Class II13 INICU Medical, Inc.
2020-10-28Z-0208-2021Class II12"ICU Medical, Inc.
2020-10-28Z-0209-2021Class II9ICU Medical, Inc.
2020-10-28Z-0210-2021Class II13 INICU Medical, Inc.
2020-10-28Z-0211-2021Class II5ICU Medical, Inc.
2020-10-28Z-0212-2021Class IINanoClave Stopcock w/NanoClaveICU Medical, Inc.
2020-10-28Z-0213-2021Class II2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating LuerICU Medical, Inc.
2020-10-28Z-0214-2021Class II99 INICU Medical, Inc.
2020-10-28Z-0215-2021Class II29 INICU Medical, Inc.
2020-10-28Z-0216-2021Class II54 INICU Medical, Inc.
2020-10-28Z-0217-2021Class IIAppx 0ICU Medical, Inc.
2020-10-28Z-0218-2021Class II126"ICU Medical, Inc.
2020-10-28Z-0219-2021Class II113"ICU Medical, Inc.
2020-10-28Z-0220-2021Class IIAppx 0ICU Medical, Inc.
2020-10-28Z-0221-2021Class II83"ICU Medical, Inc.
2020-10-28Z-0222-2021Class II123 INICU Medical, Inc.
2020-10-28Z-0223-2021Class II26 INICU Medical, Inc.
2020-10-28Z-0224-2021Class II3-Port NanoClave Manifold w/Check ValveICU Medical, Inc.
2020-10-28Z-0225-2021Class II112 INICU Medical, Inc.
2020-10-28Z-0226-2021Class II112 INICU Medical, Inc.
2020-10-28Z-0227-2021Class II142 INICU Medical, Inc.
2020-10-28Z-0228-2021Class II112 INICU Medical, Inc.
2020-10-28Z-0229-2021Class II78 INICU Medical, Inc.
2020-10-28Z-0230-2021Class II114"ICU Medical, Inc.
2020-10-28Z-0231-2021Class II10 INICU Medical, Inc.
2020-10-28Z-0232-2021Class II58 INICU Medical, Inc.
2020-10-28Z-0233-2021Class II139"ICU Medical, Inc.
2020-10-28Z-0234-2021Class II47 INICU Medical, Inc.
2020-10-28Z-0235-2021Class II10 INICU Medical, Inc.
2020-10-28Z-0236-2021Class II7 INICU Medical, Inc.
2020-10-28Z-0237-2021Class II20 INICU Medical, Inc.
2020-10-28Z-0238-2021Class II11"ICU Medical, Inc.
2020-10-28Z-0239-2021Class IIAPPX 0ICU Medical, Inc.
2020-10-28Z-0240-2021Class II11 INICU Medical, Inc.
2020-10-28Z-0241-2021Class II6 INICU Medical, Inc.
2020-10-28Z-0242-2021Class II11 INICU Medical, Inc.
2020-10-28Z-0243-2021Class II78"ICU Medical, Inc.
2020-10-28Z-0244-2021Class II128"ICU Medical, Inc.
2020-10-28Z-0245-2021Class II126 INICU Medical, Inc.
2020-10-28Z-0246-2021Class II40ICU Medical, Inc.
2020-10-28Z-0247-2021Class II7 INICU Medical, Inc.
2020-10-28Z-0248-2021Class II6ICU Medical, Inc.
2020-10-28Z-0249-2021Class II6 INICU Medical, Inc.
2020-10-28Z-0250-2021Class IIClave StopcockICU Medical, Inc.
2020-10-28Z-0251-2021Class II60 INICU Medical, Inc.
2020-10-28Z-0252-2021Class II120 INICU Medical, Inc.
2020-10-28Z-0253-2021Class II60 INICU Medical, Inc.
2020-10-28Z-0254-2021Class II22"ICU Medical, Inc.
2020-10-28Z-0255-2021Class II148 INICU Medical, Inc.
2020-10-28Z-0256-2021Class II149 INICU Medical, Inc.
2020-10-28Z-0257-2021Class II98 INICU Medical, Inc.
2020-10-28Z-0258-2021Class II112"ICU Medical, Inc.
2020-10-28Z-0259-2021Class II5ICU Medical, Inc.
2020-10-28Z-0260-2021Class II124"ICU Medical, Inc.
2020-10-28Z-0261-2021Class IINanoClave ConnectorICU Medical, Inc.
2020-10-28Z-0262-2021Class II8 INICU Medical, Inc.
2020-10-28Z-0263-2021Class IINanoClave ConnectorICU Medical, Inc.
2020-10-28Z-0264-2021Class II11 INICU Medical, Inc.

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