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-0365-2016 | Class II | Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050 | Philips North America LLC | KPR | |
| Z-2665-2014 | Class II | Siemens CentraLink Data Management System, software version 14. The CentraLink system... | Siemens Healthcare Diagnostics Inc. | N/A | |
| Z-0364-2016 | Class II | Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model... | Philips North America LLC | KPR | |
| Z-2622-2014 | Class I | 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller... | Abbott Medical | FMG | |
| Z-2621-2014 | Class I | 83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller... | Abbott Medical | FMG | |
| Z-2620-2014 | Class I | STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2... | Abbott Medical | FMG | |
| Z-2619-2014 | Class I | STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2... | Abbott Medical | FMG | |
| Z-2572-2014 | Class II | Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311... | Abbott Medical | LWS | |
| Z-2716-2014 | Class II | ADVIA Centaur XP Immunoassay System (including refurbished units), This system is... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-2715-2014 | Class II | ADVIA Centaur Immunoassay System (including refurbished units), This system is intended... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0201-2015 | Class II | Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland)... | Integra LifeSciences Corporation | GWM | |
| Z-2654-2014 | Class II | 4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance... | Varian Medical Systems, Inc. | MUJ | |
| Z-2720-2014 | Class II | Siemens Dimension Vista CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic... | Siemens Healthcare Diagnostics Inc. | JIX | |
| Z-2581-2014 | Class II | Monaco The Monaco system is used to make treatment plans for patients with... | Elekta Limited | MUJ | |
| Z-2574-2014 | Class II | FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient... | Elekta Limited | MUJ | |
| Z-2564-2014 | Class II | Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and... | FUJIFILM Healthcare Americas Corporation | LNH | |
| Z-1635-2015 | Class II | Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp., A... | Howmedica Osteonics Corp | JWH | |
| Z-1634-2015 | Class II | Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., A subsidiary... | Howmedica Osteonics Corp | JWH | |
| Z-1633-2015 | Class II | Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics... | Howmedica Osteonics Corp | LPH | |
| Z-2733-2014 | Class II | Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system... | Lumenis Ltd | HQF | |
| Z-2732-2014 | Class II | LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I... | Apollo Endosurgery, Inc. | LTI | |
| Z-2623-2014 | Class II | Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used... | Medtronic Heart Valves Division | DYE | |
| Z-2637-2014 | Class II | ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a... | Data Innovations, LLC | JQP | |
| Z-0747-2016 | Class II | Synthes Small Electric Drive (SED). For use in general traumatology. | The Anspach Effort, Inc. | HTC | |
| Z-0133-2015 | Class II | SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models... | Sam Medical Products | DXC | |
| Z-0127-2015 | Class II | Dimension Vista HbA1c | Siemens Healthcare Diagnostics Inc. | LCP | |
| Z-0023-2015 | Class II | Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek and LDPE/PET... | Biomedix Wai | FPA | |
| Z-2571-2014 | Class II | V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE)... | Siemens Medical Solutions USA, Inc. | ITX | |
| Z-2688-2014 | Class II | RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who... | Smith & Nephew, Inc. | OMP | |
| Z-2706-2014 | Class II | Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the... | Vapotherm Inc. | BTT | |
| Z-2705-2014 | Class II | Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox... | Vapotherm Inc. | BTT | |
| Z-2704-2014 | Class II | Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged... | Vapotherm Inc. | BTT | |
| Z-2703-2014 | Class II | Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the... | Vapotherm Inc. | BTT | |
| Z-2702-2014 | Class II | Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the... | Vapotherm Inc. | BTT | |
| Z-2701-2014 | Class II | Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox... | Vapotherm Inc. | BTT | |
| Z-2700-2014 | Class II | Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the... | Vapotherm Inc. | BTT | |
| Z-2699-2014 | Class II | Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the... | Vapotherm Inc. | BTT | |
| Z-0132-2015 | Class II | Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump... | Maquet Cardiovascular LLC | MWS | |
| Z-2663-2014 | Class II | ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN)... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-2662-2014 | Class II | ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN)... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-2636-2014 | Class II | Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single... | Volcano Corporation | DQO | |
| Z-2644-2014 | Class III | JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable... | BioFire Defense, LLC | NHT | |
| Z-0913-2015 | Class II | The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-0912-2015 | Class II | The Siemens Symbia T series is intended for use by appropriately trained health care... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-0911-2015 | Class II | The Siemens Symbia S series is intended for use by appropriately trained health care... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2610-2014 | Class II | PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35)... | Ethicon Endo-Surgery Inc | GAG | |
| Z-2649-2014 | Class II | AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0009-2015 | Class II | eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch... | Gendex Corp. | EHD | |
| Z-0839-2015 | Class II | Neodent Titamax WS Cortical Implant 4.0 x 5 mm (Endosseous dental implant) Article... | Straumann USA, LLC | DZE | |
| Z-2692-2014 | Class II | ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA... | Horiba Instruments Incorporated | JGJ |