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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,486 records, page 337 of 1190
FDA device recalls, page 337 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2498-2020Class IICOOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5...CooperSurgical, Inc.LOB
Z-2523-2020Class IIEasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic...Philips North America LLCJAA
Z-2546-2020Class IIZenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is...Cook IncorporatedMIH
Z-2474-2020Class IIFlow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx OnlyBaxter Healthcare CorporationMVR
Z-2533-2020Class IIRUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code...Teleflex MedicalBTR
Z-2659-2020Class IISafe-T PLUS Thora-Para 5 Fr Catheter Drainage TrayMedtronic, Inc.PXI
Z-2658-2020Class IISafe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug FreeMedtronic, Inc.PXI
Z-2657-2020Class IIThora-Para 5 Fr Catheter Drainage TrayMedtronic, Inc.PXI
Z-2656-2020Class IISafe-T PLUS Thora-Para 8 Fr Catheter Drainage TrayMedtronic, Inc.PXI
Z-2655-2020Class IISafe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection - Drug FreeMedtronic, Inc.PXI
Z-2654-2020Class IIThora-Para 8 Fr Catheter Drainage Tray w/o LidocaineMedtronic, Inc.PXI
Z-2653-2020Class IIThora-Para 8 Fr Catheter Drainage TrayMedtronic, Inc.PXI
Z-2652-2020Class IISafe-T-Centesis PLUS 8 Fr Catheter Drainage TrayMedtronic, Inc.PXI
Z-2651-2020Class IISafe-T-Centesis 8 Fr Catheter Drainage TrayMedtronic, Inc.PXI
Z-2650-2020Class IISafe-T-Centesis PLUS 6 Fr Catheter Drainage TrayMedtronic, Inc.PXI
Z-2649-2020Class IISafe-T-Centesis 6 Fr Catheter Drainage Tray w/o LidocaineMedtronic, Inc.PXI
Z-2648-2020Class IISafe-T-Centesis 6 Fr Catheter Drainage TrayMedtronic, Inc.PXI
Z-2647-2020Class IISafe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage TrayMedtronic, Inc.PXI
Z-2646-2020Class IIThora-Para 5 Fr Non-Valved Catheter Drainage TrayMedtronic, Inc.PXI
Z-2492-2020Class IIProdimed Combicath Paediatric catheters for blind protected distal bronchial sampling-"...Prodimed Plastimed DivisionEOQ
Z-2491-2020Class IIProdimed Combicath Paediatric catheters for blind protected distal bronchial...Prodimed Plastimed DivisionEOQ
Z-2490-2020Class IIProdimed Combicath catheters for blind or fibrescope-guided protected distal bronchial...Prodimed Plastimed DivisionEOQ
Z-2489-2020Class IIProdimed Combicath catheters for blind or fibrescope-guided protected distal bronchial...Prodimed Plastimed DivisionEOQ
Z-2488-2020Class IIProdimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x...Prodimed Plastimed DivisionEOQ
Z-2487-2020Class IIProdimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x...Prodimed Plastimed DivisionEOQ
Z-2432-2020Class IIRP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material...Siemens Healthcare Diagnostics Inc.CHL
Z-2672-2020Class IIANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEMCG MedTech Co., Ltd.NKB
Z-2426-2020Class IIRayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B...RaySearch Laboratories AB (publ)MUJ
Z-2494-2020Class IIBlood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI...Radiometer Medical ApSCHL
Z-2485-2020Class IIPediatric Adjustable Flange Tracheostomy Tube CufflessAbbott MedicalJOH
Z-2493-2020Class IIBlood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI...Radiometer Medical ApSCHL
Z-2641-2020Class IIComputed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The...Shanghai United Imaging Healthcare Co., Ltd.JAK
Z-0090-2021Class IIACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5FSiemens Medical Solutions USA, Inc.OBJ
Z-2471-2020Class IIFujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the...FUJIFILM Healthcare Americas CorporationLLZ
Z-2541-2020Class IITactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN...Abbott MedicalOAE
Z-2423-2020Class IIAIA-900 Analyzer, Part no. 022930, UDI 04560189283992Tosoh Bioscience IncKHO
Z-2537-2020Class IIVistaSolution, physiological signal transmitter. A software graphical user interface for...VitalConnect, Inc.DRG
Z-2297-2020Class IIElekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0...Elekta LimitedIYE
Z-2484-2020Class IIVITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461...Ortho-Clinical Diagnostics, Inc.JJE
Z-2483-2020Class IIVITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product...Ortho-Clinical Diagnostics, Inc.JJE
Z-2482-2020Class IIVITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413...Ortho-Clinical Diagnostics, Inc.JJE
Z-2481-2020Class IIVITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique...Ortho-Clinical Diagnostics, Inc.JJE
Z-2480-2020Class IIVITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code...Ortho-Clinical Diagnostics, Inc.JJE
Z-2399-2020Class IILeica ARveo and M530 OH6 microscope systems.Leica Microsystems, Inc.EPT
Z-2417-2020Class IArrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code...Arrow International LLC (subsidiary of Teleflex Incorporated)DSP
Z-2416-2020Class IArrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code...Arrow International LLC (subsidiary of Teleflex Incorporated)DSP
Z-2415-2020Class IArrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535Arrow International LLC (subsidiary of Teleflex Incorporated)DSP
Z-2414-2020Class IArrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NLArrow International LLC (subsidiary of Teleflex Incorporated)DSP
Z-2413-2020Class IArrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500JArrow International LLC (subsidiary of Teleflex Incorporated)DSP
Z-2412-2020Class IArrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500IArrow International LLC (subsidiary of Teleflex Incorporated)DSP