510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
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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

59,528 records, page 722 of 1191
FDA device recalls, page 722 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0782-2014Class IIUP & UP kids' power toothbrushRanir LLCJEQ
Z-0781-2014Class IITopCare Clifford THE BIG RED DOG power toothbrush for kids!Ranir LLCJEQ
Z-0929-2014Class IIADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro...Siemens Healthcare Diagnostics Inc.DIP
Z-0729-2014Class IIAnspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C...The Anspach Effort, Inc.HBE
Z-0728-2014Class IIAnspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part #...The Anspach Effort, Inc.HBE
Z-0727-2014Class IIAnspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L...The Anspach Effort, Inc.HBE
Z-0726-2014Class IIAnspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part...The Anspach Effort, Inc.HBE
Z-0800-2014Class IISiemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry...Siemens Healthcare Diagnostics Inc.JJE
Z-0920-2014Class IIFresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number...Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-1080-2014Class IISiemens Artis zee Ceiling Systems. Angiographic x-ray system.Siemens Medical Solutions USA, Inc.IZI
Z-0648-2014Class IISOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare...GE HealthcareMHX
Z-0611-2014Class IPuritan Bennett 840 ventilator systems software part number 4-070212-85, revision...Medtronic, Inc.CBK
Z-0746-2014Class IISTERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization...Advanced Sterilization ProductsFLF
Z-0745-2014Class IISTERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System...Advanced Sterilization ProductsFLF
Z-0744-2014Class IISTERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System...Advanced Sterilization ProductsMLR
Z-1468-2014Class IICODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows...Cerenovus, Inc.JXG
Z-0923-2014Class IISuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count...G & H Wire CompanyDZC
Z-0922-2014Class IISuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count...G & H Wire CompanyDZC
Z-0921-2014Class IIB. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of...B Braun Medical IncMEB
Z-0911-2014Class IIGE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The...GE HealthcareOWB
Z-0917-2014Class IIUpgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628...GE HealthcareBTL
Z-0916-2014Class IIStand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001...GE HealthcareBTL
Z-0915-2014Class IIStand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled...GE HealthcareBTM
Z-0914-2014Class IIStand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE...GE HealthcareBTM
Z-0913-2014Class IIPanda iRes Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part...GE HealthcareFMT
Z-0912-2014Class IIGiraffe Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880...GE HealthcareFMT
Z-1069-2014Class IIVirtuoSaph Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx...Terumo Cardiovascular Systems CorporationGCJ
Z-2151-2014Class IILatex Dental Dams labeled as Non-Latex Dental DamsColtene /Whaledent AGEIE
Z-1163-2014Class IIGE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ...GE HealthcareOWB
Z-0972-2014Class IITSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.Canon Medical Systems USA, Inc.JAK
Z-0786-2014Class IISIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview...Siemens Medical Solutions USA, Inc.KPQ
Z-0619-2014Class IIIAdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of...Advandx, Inc.JSS
Z-1058-2014Class IIExternal Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only...BioHorizons Implant Systems IncDZE
Z-0714-2014Class IIDraeger Infinity Acute Care System Monitoring SolutionDraeger Medical Systems, Inc.MHX
Z-0570-2014Class IIPhilips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart...Philips North America LLCMKJ
Z-0610-2014Class IIVersys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty...Zimmer GmbHJDI
Z-0609-2014Class IITrabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder...Zimmer GmbHKWT
Z-0608-2014Class IICPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer...Zimmer GmbHJDI
Z-1455-2014Class IIGambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s)...Gambro Renal ProductsFJK
Z-0832-2014Class IIBrilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare...Philips North America LLCJAK
Z-0899-2014Class II25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.25P...Synergetics IncHQB
Z-0898-2014Class II23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.23P...Synergetics IncHQB
Z-0870-2014Class IIBD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems...Becton Dickinson & CoMDB
Z-0869-2014Class IIBD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument...Becton Dickinson & CoMDB
Z-0897-2014Class II25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P...Synergetics IncHQB
Z-0896-2014Class II23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.22.23P...Synergetics IncHQB
Z-0895-2014Class IIStiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, sterile / EO...Synergetics IncHQB
Z-0894-2014Class II23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO...Synergetics IncHQB
Z-0893-2014Class IIWide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., 20ga...Synergetics IncHQB
Z-0892-2014Class IIVivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO...Synergetics IncHQB