510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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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 772 of 1190
FDA device recalls, page 772 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0462-2013Class II24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for use in perfusion...Terumo Cardiovascular Systems CorporationDWF
Z-0461-2013Class II24 Fr 8mm Soft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in...Terumo Cardiovascular Systems CorporationDWF
Z-0460-2013Class II18 Fr 6mm Sft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in...Terumo Cardiovascular Systems CorporationDWF
Z-0459-2013Class II18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic Cannula is indicated for use in...Terumo Cardiovascular Systems CorporationDWF
Z-0458-2013Class II24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use in perfusion...Terumo Cardiovascular Systems CorporationDWF
Z-0457-2013Class II24 Fr 8mm Sft Flow Straight Wir The Sarns Aortic Cannula is indicated for use in...Terumo Cardiovascular Systems CorporationDWF
Z-0456-2013Class II24 Fr 8mm Sft Flow Str Wire W/L The Sarns Aortic Cannula is indicated for use in...Terumo Cardiovascular Systems CorporationDWF
Z-2671-2016Class IICentricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended...GE HealthcareJQP
Z-0865-2014Class IIIThe Centricity Laboratory System is intended to be an information system designed to...GE HealthcareJQP
Z-1585-2013Class IIThe Centricity Laboratory System is intended to be an information system designed to...GE HealthcareJQP
Z-0505-2013Class IIWANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central...ConMed CorporationEOQ
Z-0504-2013Class IIWANG Transbronchial Aspiration Needles Cat. No. SW-121, WANG Cytology Needles, Central...ConMed CorporationEOQ
Z-0503-2013Class IIWANG Transbronchial Aspiration Needles Cat. No. MW-322, WANG Cytology Needles, Central...ConMed CorporationEOQ
Z-0502-2013Class IIWANG Transbronchial Aspiration Needles Cat. No. MW-222, WANG Cytology Needles, Central...ConMed CorporationEOQ
Z-0621-2013Class IFisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m...Fisher & Paykel Healthcare, Inc.BZO
Z-0618-2013Class IIMedtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive...Medtronic, Inc.DWF
Z-0562-2013Class IITitanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL...BioHorizons Implant Systems IncDZE
Z-0561-2013Class IIAutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL...BioHorizons Implant Systems IncDZE
Z-0514-2013Class IPatient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit...Cutler CampusLSZ
Z-0538-2013Class IICoonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals...Zimmer GmbHJDC
Z-0537-2013Class IICOONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE...Zimmer GmbHJDC
Z-0696-2013Class IIIRoche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.Roche Diagnostics GmbHJJE
Z-2739-2016Class IICentricity Enterprise Archive is a software product for receiving, archiving and sending...GE HealthcareLMB
Z-1118-2013Class IIClinical Chemistry Phenobarbital, list number 1E08Abbott MedicalDLZ
Z-0529-2013Class IIDePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek...DePuy Mitek, Inc.HTO
Z-0525-2013Class IPraxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number...Praxair, Inc.CAN
Z-0477-2013Class IIEnterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh...Arjo, Inc.FNL
Z-0476-2013Class IIEnterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov...Arjo, Inc.FNL
Z-2579-2016Class IIGE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and...GE HealthcareLLZ
Z-0822-2013Class IIViterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468...Viterion Telehealthcare, LLCMWI
Z-0821-2013Class IIViterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US)...Viterion Telehealthcare, LLCMWI
Z-0820-2013Class IIViterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218...Viterion Telehealthcare, LLCMWI
Z-0526-2013Class IIEEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and RelaxationEEG InfoHCC
Z-0789-2013Class IIConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual...Linvatec CorporationLXH
Z-0533-2013Class IIBiomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee...Zimmer GmbHMBV
Z-0672-2013Class IBausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium...Bausch & Lomb IncorporatedHMX
Z-1068-2013Class IIToshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports...Canon Medical Systems USA, Inc.JAK
Z-2188-2013Class IOutlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used...B Braun Medical IncFRN
Z-0555-2013Class IIPersona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size...Zimmer GmbHJWH
Z-0554-2013Class IIPersona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size...Zimmer GmbHJWH
Z-0553-2013Class IIPersona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size...Zimmer GmbHJWH
Z-0552-2013Class IIPersona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size...Zimmer GmbHJWH
Z-0551-2013Class IIPersona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size...Zimmer GmbHJWH
Z-0550-2013Class IIPersona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size...Zimmer GmbHJWH
Z-0549-2013Class IIPersona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile...Zimmer GmbHJWH
Z-0548-2013Class IIPersona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, Nonsterile...Zimmer GmbHJWH
Z-0547-2013Class IIPersona, The Personalized Knee System, Tibial Broach,, Cemented, Size C-D, Nonsterile...Zimmer GmbHJWH
Z-0546-2013Class IIPersona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter...Zimmer GmbHJWH
Z-0545-2013Class IIPersona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter...Zimmer GmbHJWH
Z-0544-2013Class IIPersona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed...Zimmer GmbHJWH