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-0826-2007 | BinaxNOW A&B Kit 10 Test Kit (Japan) Part No. 416-110J contains NP Swabs with '8995'... | Abbott Diagnostics Scarborough, Inc. | GNX | ||
| Z-0825-2007 | BinaxNOW Nasopharyngeal (NP) Accessory Pak, Part Number 400-065, contain NP Swabs with... | Abbott Diagnostics Scarborough, Inc. | GNX | ||
| Z-0824-2007 | BinaxNOW RSV 10 Test Kit Part Number : 430-100, contains NP Swabs with '8995' labeled on... | Abbott Diagnostics Scarborough, Inc. | GQG | ||
| Z-0823-2007 | BinaxNOW Influenza A&B 22 Test Kit Part Number: 416-022, contains NP Swabs with '8995'... | Abbott Diagnostics Scarborough, Inc. | GNX | ||
| Z-0822-2007 | BinaxNOW Influenza A&B 10 Test KIT Part Number: 416-110 contains NP Swabs with '8995'... | Abbott Diagnostics Scarborough, Inc. | GNX | ||
| Z-0792-2007 | ARCHITECT Folate Reagent, for in vitro diagnostics, List Numbers 07K60-20 (4 x 100 test... | Abbott Medical | CGN | ||
| Z-0791-2007 | ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01... | Abbott Medical | JJE | ||
| Z-0790-2007 | ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01... | Abbott Medical | JJE | ||
| Z-0835-2007 | ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product... | DSM Biomedical, Inc. | FRO | ||
| Z-0834-2007 | FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02. The product is... | DSM Biomedical, Inc. | FRO | ||
| Z-0833-2007 | TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire)... | DSM Biomedical, Inc. | FRO | ||
| Z-0057-2008 | ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model PMB01... | Halyard Health | MED | ||
| Z-1196-2007 | ABL80 FLEX Analyzer, Model #393-839 | Sendx Medical, Inc. | CHL | ||
| Z-0868-2007 | Profemur R, Revision Hip system, Proximal Body (part), STD 4, REF: PPW38354, Cementless... | Wright Medical Technology Inc | LZO | ||
| Z-0867-2007 | Profemur R, Revision Hip system, Proximal Body (part), X-Small model, REF: PPW38364... | Wright Medical Technology Inc | LZO | ||
| Z-0778-2007 | GEM Premier 4000 Laboratory Analyzer | Instrumentation Laboratory Co. | CHL | ||
| Z-2127-2012 | Class II | UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and... | GE Healthcare | JAA | |
| Z-2126-2012 | Class II | OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital... | GE Healthcare | IZL | |
| Z-2125-2012 | Class II | OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide... | GE Healthcare | IZL | |
| Z-1044-2007 | GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular... | GE Healthcare | MQB | ||
| Z-1043-2007 | GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and... | GE Healthcare | MQB | ||
| Z-0871-2007 | GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and... | GE Healthcare | MQB | ||
| Z-0870-2007 | GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular... | GE Healthcare | MQB | ||
| Z-0869-2007 | GE Healthcare Innova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular... | GE Healthcare | MQB | ||
| Z-0384-2008 | Siemens, Mevatron M2 Primus, Part No.: 19 40 035, Mid-Energy Medical Charge particle... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0383-2008 | Siemens, ONCOR Avante Garde, Part No.: 58 63 472,Medical Charge particle radiation... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0382-2008 | Siemens, Oncor Impression, Part No.: 58 57 920, Medical Charge particle radiation therapy... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0381-2008 | Siemens, Oncor Impression Plus, Part No.: 58 57 912, Medical Charge particle radiation... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0380-2008 | Siemens, Mevatron M2/PRIMUS Plus, Part No.: 45 04 200, High EnergyMedical Charge particle... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-1055-2007 | VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous... | Boston Scientific Corporation | NIK | ||
| Z-1054-2007 | VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant... | Boston Scientific Corporation | NIK | ||
| Z-0764-2007 | Practix 300 Mobile X-ray systems. The systems are used in general purpose diagnostic... | Philips North America LLC | IZL | ||
| Z-0763-2007 | Practix 160 Mobile X-ray systems. The systems are used in general purpose diagnostic... | Philips North America LLC | IZL | ||
| Z-0762-2007 | Practix 33 Mobile X-ray systems. The systems are used in general purpose diagnostic... | Philips North America LLC | IZL | ||
| Z-1053-2007 | VITALITY 2 (model T165, T175), VITALITY DS (model T125, T135), VITALITY EL (model T127)... | Boston Scientific Corporation | NIK | ||
| Z-1052-2007 | VITALITY AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular... | Boston Scientific Corporation | NIK | ||
| Z-1051-2007 | These models are not available in the US. CONTACT RENEWAL 4 AVT HE (model number M170... | Boston Scientific Corporation | NIK | ||
| Z-1050-2007 | These models are not available in the US. Guidant CONTAK RENEWAL 4 RF/HE (model H230... | Boston Scientific Corporation | NIK | ||
| Z-1049-2007 | CONTAK RENEWAL 3 RF (model H210, H215), CONTAK RENEWAL 3 RF HE (model H217, H219) cardiac... | Boston Scientific Corporation | NIK | ||
| Z-1048-2007 | These models are not available in the US. CONTAK RENEWAL 4 (model H190, H195). CONTAK... | Boston Scientific Corporation | NIK | ||
| Z-1047-2007 | CONTAK RENEWAL 3 (model H170, H175) CONTAK RENEWAL 3 HE (model H177, H179) Cardiac... | Boston Scientific Corporation | NIK | ||
| Z-0861-2007 | Infant Nasal CPAP Cannula, Size 4; an Rx infant nasal prong continuous positive airway... | Teleflex Medical | BZD | ||
| Z-0860-2007 | Infant Nasal CPAP Cannula, Size 3; an Rx infant nasal prong continuous positive airway... | Teleflex Medical | BZD | ||
| Z-0859-2007 | Infant Nasal CPAP Cannula, Size 2; an Rx infant nasal prong continuous positive airway... | Teleflex Medical | BZD | ||
| Z-0858-2007 | Infant Nasal CPAP Cannula, Size 1; an Rx infant nasal prong continuous positive airway... | Teleflex Medical | BZD | ||
| Z-0857-2007 | Infant Nasal CPAP Cannula, Size 0; an Rx infant nasal prong continuous positive airway... | Teleflex Medical | BZD | ||
| Z-0181-2008 | GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with... | GE Healthcare | LLZ | ||
| Z-0169-2008 | PRIMUS Plus,Medical charge-particle radiation therapy system (Medical Digital Linear... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0168-2008 | MEVATRON M2/PRIMUS Mid,Medical charge-particle radiation therapy system (Medical Digital... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0167-2008 | ONCOR IMPRESSION,Medical charge-particle radiation therapy system (Medical Digital Linear... | Siemens Medical Solutions USA, Inc. | IYE |