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-2358-2008 | GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an... | GE Healthcare | MQB | ||
| Z-2357-2008 | GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha... | GE Healthcare | MQB | ||
| Z-2356-2008 | GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI... | GE Healthcare | MQB | ||
| Z-2311-2008 | Stryker Biotech OP- 1 Implant is indicated for use as an alternative to autograft in... | Stryker Biotech | MPW | ||
| Z-2203-2008 | 740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1... | Cas Medical Systems, Inc. | MHX | ||
| Z-0668-2009 | Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic. | Siemens Healthcare Diagnostics Inc. | JHX | ||
| Z-0013-2009 | Edwards Lifesciences***Fogarty Fortis***Arterial Embolectomy Catheter Is indicated for... | Edwards Lifesciences LLC | MJN | ||
| Z-2347-2008 | KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the... | Medtronic, Inc. | LXH | ||
| Z-2307-2008 | NeuViz Dual series computed Tomography Scanner System, X-Ray System | Neusoft Medical Systems Co., Ltd. | JAK | ||
| Z-0972-2009 | Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe; Model Number... | Stryker Corp. | GEI | ||
| Z-0305-2009 | Giraffe OmniBed, labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723... | GE Healthcare | FMZ | ||
| Z-0014-2009 | Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers... | Intraop Medical Corp. | LHN | ||
| Z-2234-2008 | StatSampler 200 uL, Li Heparin (micro blood collector) Ref: SS2H Packed in Catalog... | StatSpin, Inc., dba Iris Sample Processing | JKA | ||
| Z-2075-2017 | Class III | Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument | Zimmer CAS | HAW | |
| Z-0088-2009 | Envision E700 Low Airloss Therapy Surface, Made By Hill-Rom Manufacturing, Inc... | Hill-Rom Manufacturing, Inc. | IOQ | ||
| Z-2365-2008 | Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917541... | Boston Scientific Corporation | DQX | ||
| Z-2364-2008 | Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917531... | Boston Scientific Corporation | DQX | ||
| Z-2363-2008 | Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917521... | Boston Scientific Corporation | DQX | ||
| Z-2362-2008 | Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917511... | Boston Scientific Corporation | DQX | ||
| Z-2229-2008 | Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo... | CMR Naviscan Corporation | KPS | ||
| Z-1423-2009 | Sybaritic, Inc., SlimLine Health Environment Capsule, a dry heat body chamber with... | Sybaritic, Inc. | ISA | ||
| Z-1308-2009 | Lumi 8 Intense LED Light Facial System, Sybaritic, Inc.,9220 James Ave South Minneapolis... | Sybaritic, Inc. | OHS | ||
| Z-2388-2008 | Physio-Control Lifepak 20 defibrillator/monitor is intended for the termination of... | Physio Control, Inc. | MKJ | ||
| Z-2137-2008 | Isoloc Software, Version 6.6, 6.5 and 6.0. Part Number MT-NW-425-520. Software... | CIVCO Medical Instruments Co., Inc. | IYE | ||
| Z-1476-2009 | GE Innova 4100 / 4100 IQ Cardiovascular Imaging System, GE Healthcare, Waukesha, WI... | GE Healthcare | MQB | ||
| Z-1475-2009 | GE Innova 3100 / 3100 IQ Cardiovascular Imaging System, GE Healthcare, Waukesha, WI... | GE Healthcare | MQB | ||
| Z-1474-2009 | GE Innova 2100 IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha... | GE Healthcare | MQB | ||
| Z-2237-2008 | EndoVive Safety PEG Kits 20 F Universal Product Number (UPN): MOO566460 The product... | Boston Scientific Corporation | KNT | ||
| Z-2236-2008 | EndoVive Safety PEG Kits 24 F Universal Product Number (UPN): MOO56648 1 The product... | Boston Scientific Corporation | KNT | ||
| Z-2334-2008 | ZOLL OneStep Multi-Function Electrode; Adult Complete Part #: 8900-0214-01. The... | ZOLL Medical Corporation | MLN | ||
| Z-2239-2008 | ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version 1.01 and... | Abbott Medical | JJE | ||
| Z-2200-2008 | Intran Plus, Disposable Intrauterine Pressure Catheter System, Part numbers IUP-400... | Utah Medical Products, Inc | HFN | ||
| Z-0187-2009 | Medtronic DBS" 3389 Lead Kit for Deep brain stimulation, DBS Leads: Proximal 40 mm... | Medtronic Neuromodulation | MHY | ||
| Z-0186-2009 | Medtronic DBS" 3387 Lead Kit for Deep brain stimulation, DBS Leads: Proximal 40 mm... | Medtronic Neuromodulation | MHY | ||
| Z-0185-2009 | Medtronic DBS" 3389S-40 Lead Kit for Deep Brain Stimulation , length: 40 cm. Contents of... | Medtronic Neuromodulation | MHY | ||
| Z-0184-2009 | Medtronic DBS" 3387S-40 Lead Kit for Deep Brain Stimulation , length: 40 cm. Contents of... | Medtronic Neuromodulation | MHY | ||
| Z-2459-2008 | NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM... | Medtronic, Inc. | GWQ | ||
| Z-2321-2008 | Medline RF Detect Sterile X-Ray Detectable USP Type VII Gauze; 8" x 4", 12-ply, 100%... | MEDLINE INDUSTRIES, LP - Northfield | GDY | ||
| Z-2304-2008 | Abiomed : Abiocor Implantable Heart Replacement Kit System Catalog Number... | Abiomed, Inc. | LOZ | ||
| Z-2118-2013 | Class II | Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS... | Ventana Medical Systems Inc | KPA | |
| Z-0323-2011 | The device is labeled in part: " RS Medical RS-4i Stimulator". The device is sold in a... | RS Medical | IPF | ||
| Z-0304-2009 | Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length +3.5 mm... | Zimmer GmbH | LZO | ||
| Z-0303-2009 | Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length 0 mm... | Zimmer GmbH | LZO | ||
| Z-0302-2009 | Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length -3.5 mm... | Zimmer GmbH | LZO | ||
| Z-0301-2009 | Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter, neck length +3.5 mm... | Zimmer GmbH | LZO | ||
| Z-0300-2009 | Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter, neck length 0 mm... | Zimmer GmbH | LZO | ||
| Z-2308-2008 | Varian Medical Systems Eclipse device, model H48, Version 6.5 is used to plan photon and... | Varian Medical Systems, Inc. | IYE | ||
| Z-0299-2009 | Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter, neck length -3.5 mm... | Zimmer GmbH | LZO | ||
| Z-2208-2008 | ICU Medical, Inc. Cath Lab Kit W/3Port "ON" Manifold, Waste Bag, Syringe & TP4; Item... | Abbott Medical | FMG | ||
| Z-2207-2008 | Hospira Left Heart Kit for Southwestern M.C. , Item Number: 46084053 Indicated for fluid... | Abbott Medical | FMG |