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
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0782-2014 | Class II | UP & UP kids' power toothbrush | Ranir LLC | JEQ | |
| Z-0781-2014 | Class II | TopCare Clifford THE BIG RED DOG power toothbrush for kids! | Ranir LLC | JEQ | |
| Z-0929-2014 | Class II | ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro... | Siemens Healthcare Diagnostics Inc. | DIP | |
| Z-0729-2014 | Class II | Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C... | The Anspach Effort, Inc. | HBE | |
| Z-0728-2014 | Class II | Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part #... | The Anspach Effort, Inc. | HBE | |
| Z-0727-2014 | Class II | Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L... | The Anspach Effort, Inc. | HBE | |
| Z-0726-2014 | Class II | Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part... | The Anspach Effort, Inc. | HBE | |
| Z-0800-2014 | Class II | Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0920-2014 | Class II | Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number... | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-1080-2014 | Class II | Siemens Artis zee Ceiling Systems. Angiographic x-ray system. | Siemens Medical Solutions USA, Inc. | IZI | |
| Z-0648-2014 | Class II | SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare... | GE Healthcare | MHX | |
| Z-0611-2014 | Class I | Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision... | Medtronic, Inc. | CBK | |
| Z-0746-2014 | Class II | STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization... | Advanced Sterilization Products | FLF | |
| Z-0745-2014 | Class II | STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System... | Advanced Sterilization Products | FLF | |
| Z-0744-2014 | Class II | STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System... | Advanced Sterilization Products | MLR | |
| Z-1468-2014 | Class II | CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows... | Cerenovus, Inc. | JXG | |
| Z-0923-2014 | Class II | SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count... | G & H Wire Company | DZC | |
| Z-0922-2014 | Class II | SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count... | G & H Wire Company | DZC | |
| Z-0921-2014 | Class II | B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of... | B Braun Medical Inc | MEB | |
| Z-0911-2014 | Class II | GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The... | GE Healthcare | OWB | |
| Z-0917-2014 | Class II | Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628... | GE Healthcare | BTL | |
| Z-0916-2014 | Class II | Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001... | GE Healthcare | BTL | |
| Z-0915-2014 | Class II | Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled... | GE Healthcare | BTM | |
| Z-0914-2014 | Class II | Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE... | GE Healthcare | BTM | |
| Z-0913-2014 | Class II | Panda iRes Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part... | GE Healthcare | FMT | |
| Z-0912-2014 | Class II | Giraffe Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880... | GE Healthcare | FMT | |
| Z-1069-2014 | Class II | VirtuoSaph Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx... | Terumo Cardiovascular Systems Corporation | GCJ | |
| Z-2151-2014 | Class II | Latex Dental Dams labeled as Non-Latex Dental Dams | Coltene /Whaledent AG | EIE | |
| Z-1163-2014 | Class II | GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ... | GE Healthcare | OWB | |
| Z-0972-2014 | Class II | TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System. | Canon Medical Systems USA, Inc. | JAK | |
| Z-0786-2014 | Class II | SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview... | Siemens Medical Solutions USA, Inc. | KPQ | |
| Z-0619-2014 | Class III | AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of... | Advandx, Inc. | JSS | |
| Z-1058-2014 | Class II | External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only... | BioHorizons Implant Systems Inc | DZE | |
| Z-0714-2014 | Class II | Draeger Infinity Acute Care System Monitoring Solution | Draeger Medical Systems, Inc. | MHX | |
| Z-0570-2014 | Class II | Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart... | Philips North America LLC | MKJ | |
| Z-0610-2014 | Class II | Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty... | Zimmer GmbH | JDI | |
| Z-0609-2014 | Class II | Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder... | Zimmer GmbH | KWT | |
| Z-0608-2014 | Class II | CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer... | Zimmer GmbH | JDI | |
| Z-1455-2014 | Class II | Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s)... | Gambro Renal Products | FJK | |
| Z-0832-2014 | Class II | Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare... | Philips North America LLC | JAK | |
| Z-0899-2014 | Class II | 25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.25P... | Synergetics Inc | HQB | |
| Z-0898-2014 | Class II | 23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.23P... | Synergetics Inc | HQB | |
| Z-0870-2014 | Class II | BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems... | Becton Dickinson & Co | MDB | |
| Z-0869-2014 | Class II | BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument... | Becton Dickinson & Co | MDB | |
| Z-0897-2014 | Class II | 25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P... | Synergetics Inc | HQB | |
| Z-0896-2014 | Class II | 23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.22.23P... | Synergetics Inc | HQB | |
| Z-0895-2014 | Class II | Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, sterile / EO... | Synergetics Inc | HQB | |
| Z-0894-2014 | Class II | 23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO... | Synergetics Inc | HQB | |
| Z-0893-2014 | Class II | Wide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., 20ga... | Synergetics Inc | HQB | |
| Z-0892-2014 | Class II | Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO... | Synergetics Inc | HQB |
