510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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

59,544 records, page 619 of 1191
FDA device recalls, page 619 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0460-2016Class IIReagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: The Reagent...Siemens Healthcare Diagnostics Inc.JJE
Z-0459-2016Class IIReagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent...Siemens Healthcare Diagnostics Inc.JJE
Z-0458-2016Class IIReagent Management System (RMS) Dimension EXL with LM Product Usage: The Reagent...Siemens Healthcare Diagnostics Inc.JJE
Z-0452-2016Class IIZimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger...Zimmer GmbHHAB
Z-0451-2016Class IIMobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray...Shimadzu Medical SystemsIZL
Z-0422-2016Class IIFlexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These...Aesculap IncLRZ
Z-1572-2014Class IIMedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream...Cerenovus, Inc.LKK
Z-1571-2014Class IIMedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream...Cerenovus, Inc.LKK
Z-1617-2016Class IIArctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a...C.R. Bard IncDWJ
Z-0573-2016Class IISmith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM...Smith & Nephew, Inc.JWH
Z-0342-2016Class IIMedtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.Medtronic, Inc.NKE
Z-0582-2016Class IIRemote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3...Vidco, Inc.MSX
Z-2033-2017Class IIDestination Renal Guiding Sheath Intended for the introduction of interventional and...Terumo Medical Corp.DYB
Z-0483-2016Class IIMicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; The...Cardica, Inc.GDW
Z-0482-2016Class IIMicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue...Cardica, Inc.GDW
Z-0444-2016Class IIUnolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle...Myco Medical Supplies IncFMI
Z-0443-2016Class IIOxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged...Remel IncJTN
Z-0040-2018Class IIGenesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical...Genesys SpineLRZ
Z-0648-2016Class IIRT Elements are applications for radiation treatment planning for use in stereotactic...Brainlab, Inc.MUJ
Z-0647-2016Class IIRT Elements are applications for radiation treatment planning for use in stereotactic...Brainlab, Inc.MUJ
Z-0359-2016Class IIAltrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2)...ConMed CorporationGEI
Z-0445-2016Class IIAlaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and...CareFusion 303, IncFPA
Z-0398-2016Class IIThin-Flex Venous Cannula, Model Number:TF292902AEdwards Lifesciences LLCDWF
Z-0343-2016Class IICopper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952...Ormco/SybronendoDZC
Z-1499-2018Class IIIMicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the...Ortho-Clinical Diagnostics, Inc.N/A
Z-1498-2018Class IIIMicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme...Ortho-Clinical Diagnostics, Inc.OTR
Z-1497-2018Class IIIMicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of...Ortho-Clinical Diagnostics, Inc.DAK
Z-1030-2016Class IIDimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer...Siemens Healthcare Diagnostics Inc.JZG
Z-0730-2016Class IIINTEGRIS BV3000 MONO; Model Number: 72241 The Philips INTEGRIS 3000 I 5000 system is...Philips North America LLCIZI
Z-1346-2016Class IINAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN...Boston Scientific CorporationOEZ
Z-1345-2016Class IINAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094...Boston Scientific CorporationOEZ
Z-1344-2016Class IINAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN...Boston Scientific CorporationOEZ
Z-1343-2016Class IINAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311...Boston Scientific CorporationOEZ
Z-0729-2016Class IIINTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended...Philips North America LLCOWB
Z-0728-2016Class IIINTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS 3000 I 5000...Philips North America LLCOWB
Z-0727-2016Class IIINTEGRIS Allura 15-12 (mono); Model Number: 722043 The Philips INTEGRIS 3000 I 5000...Philips North America LLCOWB
Z-0726-2016Class IIINTEGRIS Allura 9 (biplane); Model Number: 722021 The Philips INTEGRIS 3000 I 5000...Philips North America LLCOWB
Z-0725-2016Class IIINTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 system is intended...Philips North America LLCIZI
Z-0724-2016Class IIINTEGRIS V5000: Model Number: 72248 The Philips INTEGRIS 3000 I 5000 system is intended...Philips North America LLCIZI
Z-0723-2016Class IIINTEGRIS BH5000; Model Number: 72247 The Philips INTEGRIS 3000 I 5000 system is intended...Philips North America LLCIZI
Z-0722-2016Class IIINTEGRIS H5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 system is intended...Philips North America LLCIZI
Z-0721-2016Class IIINTEGRIS V3000; Model Number: 72243, 72244, 72245 The Philips INTEGRIS 3000 I 5000...Philips North America LLCIZI
Z-0720-2016Class IIINTEGRIS BH3000; Model Number: 72242 The Philips INTEGRIS 3000 I 5000 system is intended...Philips North America LLCIZI
Z-0719-2016Class IIINTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 system is...Philips North America LLCIZI
Z-0718-2016Class IIINTEGRIS HM3000; Model Number: 72239 The Philips INTEGRIS 3000 I 5000 system is intended...Philips North America LLCIZI
Z-0717-2016Class IIINTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 system is intended...Philips North America LLCIZI
Z-0431-2016Class IIMYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer application...bioMerieux, Inc.JQP
Z-0430-2016Class IIMYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer application...bioMerieux, Inc.JQP
Z-0429-2016Class IIMYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a computer application (Middleware)...bioMerieux, Inc.JQP
Z-0428-2016Class IIMYLA MASTER DVD V4.0 CLI Product Usage: MYLA is a computer application (Middleware)...bioMerieux, Inc.JQP