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-0874-2009 | Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 57.5 mm, Biomet... | Zimmer GmbH | HTZ | ||
| Z-0873-2009 | Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 55 mm, Biomet... | Zimmer GmbH | HTZ | ||
| Z-2112-2009 | EnteraLite Infinity Enteral Feeding Pump, REF INFP01, Zevex Enteral Nutrition Delivery... | Zevex, Inc. | LZH | ||
| Z-0036-2010 | ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC... | Alphatec Spine, Inc. | LRP | ||
| Z-2029-2009 | Newport e360 Ventilator, Rx only. The e360 Ventilator System is intended to provide... | Newport Medical Instruments, Inc. | CBK | ||
| Z-1007-2009 | Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED... | Welch Allyn Protocol, Inc. | MKJ | ||
| Z-1006-2009 | Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED... | Welch Allyn Protocol, Inc. | MKJ | ||
| Z-1005-2009 | Welch Allyn AED 10 Automated External Defibrillator | Welch Allyn Protocol, Inc. | MKJ | ||
| Z-1405-2010 | Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and R4.2... | Elekta Limited | IYE | ||
| Z-0905-2009 | Zimmer TIV Self Tap Screw, 42 mm. Manufactured by Zimmer Manufacturing B.V., A... | Zimmer GmbH | HWC | ||
| Z-0904-2009 | Zimmer TIV Self Tap Screw, 40 mm. Manufactured by Zimmer Manufacturing B.V., A... | Zimmer GmbH | HWC | ||
| Z-0886-2009 | Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular... | Zimmer GmbH | HWT | ||
| Z-0885-2009 | Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular... | Zimmer GmbH | HWT | ||
| Z-0870-2009 | Centricity Enterprise Web 3.0 software; the software allows physicians convenient, quick... | GE Healthcare | LMD | ||
| Z-0836-2009 | GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare... | GE Healthcare | LLZ | ||
| Z-0353-2009 | EasyDiagnost Eleva x-ray systems | Philips North America LLC | JAA | ||
| Z-0352-2009 | OminDiagnost Eleva | Philips North America LLC | JAA | ||
| Z-0468-2012 | STERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizer Product Code 10133. The... | Advanced Sterilization Products | MLR | ||
| Z-0351-2009 | MultiDiagnost Eleva | Philips North America LLC | JAA | ||
| Z-0350-2009 | Integris Allura Flat Detector 9C | Philips North America LLC | IZI | ||
| Z-0349-2009 | Allura XPER FD20 | Philips North America LLC | IZI | ||
| Z-0348-2009 | Allura XPER FD20/10 | Philips North America LLC | IZI | ||
| Z-0347-2009 | Integris XPER FD10 F/C | Philips North America LLC | IZI | ||
| Z-0346-2009 | Integris BH5000 | Philips North America LLC | IZI | ||
| Z-0345-2009 | Integris H5000F | Philips North America LLC | IZI | ||
| Z-0344-2009 | Allura XPER 10/10 | Philips North America LLC | IZI | ||
| Z-1069-2009 | Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated... | Abbott Medical | GKZ | ||
| Z-2567-2011 | XiO Radiation Treatment Planning System, XiO Release 4.3.1 through 4.40.00. Used to... | Elekta Limited | MUJ | ||
| Z-0987-2009 | CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper... | Abbott Medical | FPA | ||
| Z-0929-2009 | Somatom Definition AS, Model number 8098027. Computed tomography x-ray system | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-0663-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Needle Probe (Product... | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0662-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Curved Dissector Probe... | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-1395-2009 | Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000... | Bio-Rad Laboratories Inc. | LCP | ||
| Z-0661-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Right Angle Probe... | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0660-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Spatula Probe (Product... | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0659-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Hook Probe (Product... | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0658-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Curved Dissector Probe... | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0657-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Right Angle Probe... | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0656-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Spatula Probe (Product... | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0946-2009 | Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor... | Abbott Medical | OCL | ||
| Z-0655-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Hook Probe (Product Code... | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0654-2009 | CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance. | iCAD, Inc. | LNH | ||
| Z-0653-2009 | CAD SCIENCES LLC 3TP TheraMapTM Software, for oncology treatment planning, assessment and... | iCAD, Inc. | LNH | ||
| Z-1911-2009 | Adapt AO, Akreos Advanced Optics Aspheric Lens. Bausch & Lomb Incorporated, Rochester... | Bausch & Lomb Incorporated | HQL | ||
| Z-1020-2009 | Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138... | Theragenics Corp. | NQO | ||
| Z-0933-2009 | Ergolift 400 Lbs. Floor Lift, Manufactured by BHM Medical Inc., 2001 Tanguay, Magog, QC... | Arjo, Inc. | FSA | ||
| Z-0935-2009 | Bard 3D Max Mesh, Left large , Sterile Pre-formed Knitted Polypropylene Product Code... | Davol Inc., Sub. C.R. Bard, Inc. | FTL | ||
| Z-0620-2009 | Foot switch, Part Number 1009.81. Maquet GmbH & Co. KG, 76437 Rastatt, Germany. The... | Maquet Cardiovascular Us Sales, LLC | FWZ | ||
| Z-1951-2011 | Heart Sync Adult Radiolucent Electrode -Physio Control, Part T100LO-PHYSIO. Indicated... | Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | MLN | ||
| Z-1950-2011 | Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. Indicated... | Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | MLN |