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-2308-2010 | Mitek VAPR Wedge Short Electrode (integrated) Product Code: 227213 The VAPR Electrodes... | DePuy Mitek, Inc. | GEI | ||
| Z-2307-2010 | Mitek VAPR Wedge Electrode (integrated Product Code: 227203 The VAPR Electrodes (end... | DePuy Mitek, Inc. | GEI | ||
| Z-2306-2010 | Mitek VAPR End Effect Electrode (integrated) Product Code: 227202 The VAPR Electrodes... | DePuy Mitek, Inc. | GEI | ||
| Z-2305-2010 | Mitek VAPR Side Effect Short Electrode (integrated) Product Code: 227211 The VAPR... | DePuy Mitek, Inc. | GEI | ||
| Z-2304-2010 | Mitek VAPR Hook Electrode (integrated) Product Code: 227305 The VAPR Electrodes (end... | DePuy Mitek, Inc. | GEI | ||
| Z-2303-2010 | Mitek VAPR Angled Side Effect Electrode (integrated) Product Code: 227302 The VAPR... | DePuy Mitek, Inc. | GEI | ||
| Z-2302-2010 | Mitek VAPR Flexible Side Effect Electrode (integrated) Product Code: 227312 The VAPR... | DePuy Mitek, Inc. | GEI | ||
| Z-2301-2010 | Mitek VAPR Side Effect Electrode (integrated) Product Code: 227301 The VAPR Electrodes... | DePuy Mitek, Inc. | GEI | ||
| Z-2300-2010 | Mitek VAPR Premiere 90 Electrode (integrated) Product Code: 227204 The VAPR Electrodes... | DePuy Mitek, Inc. | GEI | ||
| Z-2299-2010 | Mitek VAPR Premiere50 Electrode (integrated) Product Code: 227504 The VAPR Electrodes... | DePuy Mitek, Inc. | GEI | ||
| Z-2298-2010 | Mitek VAPR S50 Knee Electrode (integrated) Product Code: 227355 The VAPR Electrodes (end... | DePuy Mitek, Inc. | GEI | ||
| Z-2297-2010 | Mitek VAPR S90 Suction Electrode (integrated) Product Code: 225370 The VAPR Electrodes... | DePuy Mitek, Inc. | GEI | ||
| Z-0036-2011 | HLD SYSTEM 520 is a two-tank Medical Device Cleaning and High Level Disinfection Systems... | Cenorin, LLC | LDS | ||
| Z-1222-2011 | Maquet HEARTSTRING Aortic Cutter 4.3 mm, AC-3043, Lot numbers 9081071 and 9082071... | Maquet Cardiovascular LLC | FZT | ||
| Z-2165-2010 | SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham... | Bio-Logic Systems Corp. | GWJ | ||
| Z-2284-2010 | Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs... | Draeger Medical Systems, Inc. | MHX | ||
| Z-2283-2010 | Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs... | Draeger Medical Systems, Inc. | MHX | ||
| Z-2071-2010 | Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, Pre-Shaped... | Boston Scientific Corporation | DQX | ||
| Z-2070-2010 | Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, 300 cm x 10... | Boston Scientific Corporation | DQX | ||
| Z-2069-2010 | Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, Pre-Shaped... | Boston Scientific Corporation | DQX | ||
| Z-2068-2010 | Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, 200 cm x 10... | Boston Scientific Corporation | DQX | ||
| Z-1923-2010 | Innova 4100/4100IQ system with InnovaIQ Table Option Indicated for use in generating... | GE Healthcare | MQB | ||
| Z-1922-2010 | Innova 3100/ 3100IQ system with InnovaIQ Table Option Indicated for use in generating... | GE Healthcare | MQB | ||
| Z-1921-2010 | Innova 2100IQ system with InnovaIQ Table Option Indicated for use in generating... | GE Healthcare | MQB | ||
| Z-1092-2011 | Centurion Medical Products VAD access tray HT2440A, Sterile | Centurion Medical Products, LP | LRS | ||
| Z-1091-2011 | Centurion Medical Products Port access tray DT9195, Sterile. | Centurion Medical Products, LP | LRS | ||
| Z-1090-2011 | Centurion Medical Products Port access tray with sorbaview 2000 and chloraprep DT9155... | Centurion Medical Products, LP | LRS | ||
| Z-1089-2011 | Centurion Medical Products VAD access tray DT7810, Sterile. | Centurion Medical Products, LP | LRS | ||
| Z-1088-2011 | Centurion Medical Products Port access tray DT7150, Sterile. | Centurion Medical Products, LP | LRS | ||
| Z-1087-2011 | Centurion Medical Products Port access tray DT7030, Sterile | Centurion Medical Products, LP | LRS | ||
| Z-1086-2011 | Centurion Medical Products PICC line tray DT3185, Sterile. | Centurion Medical Products, LP | LRS | ||
| Z-1085-2011 | Centurion Medical Products Port access tray DT12965, Sterile. | Centurion Medical Products, LP | LRS | ||
| Z-1084-2011 | Centurion Medical Products Central line procedure kit DT12210, Sterile | Centurion Medical Products, LP | LRS | ||
| Z-1083-2011 | Centurion Medical Products Custom PICC insertion tray DT11460, Sterile. | Centurion Medical Products, LP | LRS | ||
| Z-1082-2011 | Centurion Medical Products Venous access kit, CV1515, Sterile | Centurion Medical Products, LP | LRS | ||
| Z-1081-2011 | Centurion Medical Products PICC Line Kit CV12880, Sterile. | Centurion Medical Products, LP | LRS | ||
| Z-1080-2011 | Centurion Medical Products Insertion/PPE Kit CV12590, Sterile. | Centurion Medical Products, LP | LRS | ||
| Z-1079-2011 | NeoMedical Incorporated, V -Cath Insertion Tray, REF301-00, Sterile. | Centurion Medical Products, LP | LRS | ||
| Z-1078-2011 | Centurion Medical Products V.A.D. Tray HT1995A, Sterile. | Centurion Medical Products, LP | LRS | ||
| Z-1077-2011 | Centurion Medical Products VAD access kit HT2415, Sterile. | Centurion Medical Products, LP | LRS | ||
| Z-1076-2011 | Centurion Medical Products Port access tray DT7780, Sterile. | Centurion Medical Products, LP | LRS | ||
| Z-1075-2011 | Centurion Medical Products Implanted access port tray DT7105, Sterile. | Centurion Medical Products, LP | LRS | ||
| Z-1074-2011 | Centurion Medical Products Port cath tray DT6765, Sterile. | Centurion Medical Products, LP | LRS | ||
| Z-1073-2011 | Centurion Medical Products Port access tray DT6040, Sterile. | Centurion Medical Products, LP | LRS | ||
| Z-1072-2011 | Centurion Medical Products Port access tray, DT12050, Sterile. | Centurion Medical Products, LP | LRS | ||
| Z-1071-2011 | Centurion Medical Products Central venous catheter pack, CV13225, Sterile. | Centurion Medical Products, LP | LRS | ||
| Z-1070-2011 | Centurion Medical Products Central line procedure tray, CVI3070, Sterile. | Centurion Medical Products, LP | LRS | ||
| Z-2981-2011 | Aplio XG model SSA-790A Aplio XG (SSA-790A) is a premium-class diagnostic ultrasound... | Canon Medical Systems USA, Inc. | IYO | ||
| Z-2420-2010 | Stryker Bur Guard REF 2296-301, Stryker Instruments, Kalamazoo, MI (USA) The Impaction... | Stryker Corp. | HWE | ||
| Z-0364-2011 | SA BASE with SoftLab Version 3.1.4.x. Manufactured 03/2003. SCC Soft Computer 5400... | SCC Soft Computer | JQP |