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-0985-2012 | MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 Product Code... | Philips North America LLC | IZI | ||
| Z-1094-2015 | Class II | Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the... | Synthes GmbH | MTJ | |
| Z-1141-2012 | Arasys Product Usage: Muscle stimulation | Ion Genius, Inc. | IPF | ||
| Z-1140-2012 | iPico Product Usage: Muscle stimulation | Ion Genius, Inc. | NFO | ||
| Z-1226-2012 | Integra Endoscopic Gastrocnemius Release (EGR) System. The device consists of one (1)... | Integra LifeSciences Corporation | NBH | ||
| Z-1139-2012 | IELLIOS Product Usage: Muscle stimulation | Ion Genius, Inc. | NFO | ||
| Z-1138-2012 | Ion Magnum Product Usage: Muscle stimulation | Ion Genius, Inc. | IPF | ||
| Z-1137-2012 | Perfector Product Usage: Muscle stimulation | Ion Genius, Inc. | IPF | ||
| Z-2309-2012 | Class II | Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use... | Cook Ireland Ltd. | NIO | |
| Z-1200-2012 | Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3... | Varian Medical Systems, Inc. | JAQ | ||
| Z-1199-2012 | Nucletron Adapter and Transfer Guide Tube, part number AL 13005000, a component used with... | Varian Medical Systems, Inc. | JAQ | ||
| Z-1032-2012 | The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy Cardiac... | Abbott Medical | OAD | ||
| Z-1133-2013 | Class II | GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0... | GE Healthcare | DQK | |
| Z-1130-2012 | Product Brand Names: Triage Drugs of Abuse Panel 8 Test Kit (K924476), Triage Drugs of... | Alere San Diego, Inc. | DIS | ||
| Z-1082-2012 | Microsoft Amalga - previously known as Microsoft Amalga Unified Intelligence System (UIS)... | Microsoft Corporation Health Solutions Group | JQP | ||
| Z-1035-2012 | TSX-301B: AQUILION ONE; System, X-Ray, Tomography, Computed Last four of Serial... | Canon Medical Systems USA, Inc. | JAK | ||
| Z-1034-2012 | TSX-301A: AQUILION ONE; System, X-Ray, Tomography, Computed Last four of Serial... | Canon Medical Systems USA, Inc. | JAK | ||
| Z-1031-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 76mm GROUP K, REF DSBFGK76, Rx ONLY, STERILE R... | Wright Medical Technology Inc | KWA | ||
| Z-1030-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 74mm GROUP J, REF DSBFGJ74, Rx ONLY, STERILE R... | Wright Medical Technology Inc | KWA | ||
| Z-1029-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 72mm GROUP J, REF DSBFGJ72, Rx ONLY, STERILE R... | Wright Medical Technology Inc | KWA | ||
| Z-1028-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 70mm GROUP J, REF DSBFGJ70, Rx ONLY, STERILE R... | Wright Medical Technology Inc | KWA | ||
| Z-1027-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 68mm GROUP H, REF DSBFGH68, Rx ONLY, STERILE R... | Wright Medical Technology Inc | KWA | ||
| Z-1026-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 66mm GROUP H, REF DSBFGH66, Rx ONLY, STERILE R... | Wright Medical Technology Inc | KWA | ||
| Z-1025-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 64mm GROUP H, REF DSBFGH64, Rx ONLY, STERILE R... | Wright Medical Technology Inc | KWA | ||
| Z-1024-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 62mm GROUP G, REF DSBFGG62, Rx ONLY, STERILE R... | Wright Medical Technology Inc | KWA | ||
| Z-1023-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 60mm GROUP G, REF DSBFGG60, Rx ONLY, STERILE R... | Wright Medical Technology Inc | KWA | ||
| Z-1022-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 58mm GROUP G, REF DSBFGG58, Rx ONLY, STERILE R... | Wright Medical Technology Inc | KWA | ||
| Z-1021-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 56mm GROUP F, REF DSBFGF56, Rx ONLY, STERILE R... | Wright Medical Technology Inc | KWA | ||
| Z-1020-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 54mm GROUP E, REF DSBFGE54, Rx ONLY, STERILE R... | Wright Medical Technology Inc | KWA | ||
| Z-1019-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 52mm GROUP D, REF DSBFGD52, Rx ONLY, STERILE R... | Wright Medical Technology Inc | KWA | ||
| Z-1018-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 50mm GROUP C, REF DSBFGC50, Rx ONLY, STERILE R... | Wright Medical Technology Inc | KWA | ||
| Z-1017-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 48mm GROUP B, REF DSBFGB48, Rx ONLY, STERILE R... | Wright Medical Technology Inc | KWA | ||
| Z-1016-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 46mm GROUP B, REF DSBFGB46, Rx ONLY, STERILE R... | Wright Medical Technology Inc | KWA | ||
| Z-0705-2012 | GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and... | GE Healthcare | IYN | ||
| Z-1055-2012 | ImmunoCAP Allergen Ri206, Cockroach American, Periplaneta americana It is an analyte... | Phadia AB | MVU | ||
| Z-1206-2012 | Smiths Medical, Medfusion 3500 Syringe Pumps, Software version 5.0.0, Rx Only. These... | Abbott Medical | FRN | ||
| Z-1737-2013 | Class II | KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical... | SPINEFRONTIER, Inc. dba LESspine Innovations | MNI | |
| Z-1011-2012 | Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE) Part number... | ZOLL Medical Corporation | |||
| Z-0733-2012 | Angiodynamics DuraMax 55 cm STRAIGHT --- 1-15.5F x 55cm DuraMax Hemodialysis Catheter... | Angiodynamics Worldwide Headquarters | MSD | ||
| Z-0732-2012 | Angiodynamics DuraMax 24 cm STRAIGHT --- 1-15.5F x 24cm DuraMax Hemodialysis Catheter... | Angiodynamics Worldwide Headquarters | MSD | ||
| Z-0731-2012 | Angiodynamics DuraMax 22 cm STRAIGHT --- 1-15.5F x 22cm DuraMax Hemodialysis Catheter... | Angiodynamics Worldwide Headquarters | MSD | ||
| Z-0730-2012 | Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 55cm Chronic Hemodialysis VascPak... | Angiodynamics Worldwide Headquarters | MSD | ||
| Z-0729-2012 | Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 40cm Chronic Hemodialysis VascPak... | Angiodynamics Worldwide Headquarters | MSD | ||
| Z-0728-2012 | Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 32cm Chronic Hemodialysis VascPak... | Angiodynamics Worldwide Headquarters | MSD | ||
| Z-0727-2012 | Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 28cm Chronic Hemodialysis VascPak... | Angiodynamics Worldwide Headquarters | MSD | ||
| Z-0726-2012 | Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 24cm Chronic Hemodialysis VascPak... | Angiodynamics Worldwide Headquarters | MSD | ||
| Z-0725-2012 | Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 22cm Chronic Hemodialysis VascPak... | Angiodynamics Worldwide Headquarters | MSD | ||
| Z-0724-2012 | Angiodynamics DuraMax 15.5F x 55cm Chronic Hemodialysis Catheter Set (with Cuff 50cm from... | Angiodynamics Worldwide Headquarters | MSD | ||
| Z-0723-2012 | Angiodynamics DuraMax 15.5F x 40cm Chronic Hemodialysis Catheter Set (with Cuff 35cm from... | Angiodynamics Worldwide Headquarters | MSD | ||
| Z-0722-2012 | Angiodynamics DuraMax 15.5F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31cm... | Angiodynamics Worldwide Headquarters | MSD |