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-0637-2007 | COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum Glide Antimicrobial... | Cook Incorporated | FOZ | ||
| Z-0583-2007 | Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines... | Medtronic Perfusion Systems | DWE | ||
| Z-0413-2007 | ARCHITECT i System Assay CD-ROM, in vitro diagnostic analyzer, U.S. Version 21.0; for use... | Abbott Medical | JJI | ||
| Z-0503-2007 | Alsius Cool Line Catheter, Model CL-2295AE | Alsius Corp. | NCX | ||
| Z-0502-2007 | Alsius Cool Line Catheter, Model CL-2295A | Alsius Corp. | NCX | ||
| Z-0170-2008 | Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937... | GE Healthcare | LNH | ||
| Z-0375-2007 | Davol Salute Fixation System, 18cm Reusable Shaft (Short/Open) with Handle. To attach... | Davol Inc., Sub. C.R. Bard, Inc. | GDW | ||
| Z-0374-2007 | Davol Salute Fixation System, 38cm Reusable Shaft (Laparoscopic) with Handle. To attach... | Davol Inc., Sub. C.R. Bard, Inc. | GDW | ||
| Z-0410-2007 | BD Beaver Mini-Blade, Mini/Bulk 69, Catalog Number: 374823 | Becton Dickinson & Co | HNN | ||
| Z-0409-2007 | BD Beaver Mini-Blade, Mini/Bulk 67, Catalog Number: 374822 | Becton Dickinson & Co | HNN | ||
| Z-0408-2007 | BD Beaver Mini-Blade, Mini/Bulk 64, Catalog Number: 374820 | Becton Dickinson & Co | HNN | ||
| Z-0407-2007 | BD Beaver Mini-Blade, Blade Mini Sharp All Around S/SU, Catalog Number: 376900 | Becton Dickinson & Co | HNN | ||
| Z-0406-2007 | BD Beaver Mini-Blade, Blade Mini Curved Sharp on One, Catalog Number: 376700 | Becton Dickinson & Co | HNN | ||
| Z-0405-2007 | BD Beaver Mini-Blade, Blade Mini Pointed Tip S/SU, Catalog Number: 376500 | Becton Dickinson & Co | HNN | ||
| Z-0404-2007 | BD Beaver Mini-Blade, Blade Mini RND Tip Sharp One Side, Catalog Number: 376400 | Becton Dickinson & Co | HNN | ||
| Z-0403-2007 | BD Beaver Mini-Blade, Blade Sharp Two Sides Pointed, Catalog Number: 376300 | Becton Dickinson & Co | HNN | ||
| Z-0402-2007 | BD Beaver Mini-Blade, Blade Mini Orthopedic 1.31 in, Catalog Number: 376100 | Becton Dickinson & Co | HNN | ||
| Z-0401-2007 | BD Beaver Mini-Blade, Blade Mini Orthopedic 1.255 in, Catalog Number: 374562 | Becton Dickinson & Co | HNN | ||
| Z-0170-2010 | Eon Rechargeable Implantable Pulse Generator (IPG) System | Abbott Medical | LGW | ||
| Z-0564-2007 | Alcon Custom-Pak, part #11148-02, containing BD Beaver Mini-Blade (part #BD6400 or part... | Alcon Laboratories | HNN | ||
| Z-0563-2007 | Alcon Custom-Pak, part #6515-51, containing BD Beaver Mini-Blade (part #BD6400 or part... | Alcon Laboratories | HNN | ||
| Z-0562-2007 | Alcon Custom-Pak, part #4917-54, containing BD Beaver Mini-Blade (part #BD6400 or part... | Alcon Laboratories | HNN | ||
| Z-0561-2007 | Alcon Custom-Pak, part #2638-17, containing BD Beaver Mini-Blade (part #BD6400 or part... | Alcon Laboratories | HNN | ||
| Z-0595-2007 | Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ... | Abbott Molecular, Inc. | MVU | ||
| Z-0565-2007 | CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems... | Abbott Medical | GIF | ||
| Z-0560-2007 | Alcon Custom-Pak, part #10975-02, containing BD Beaver Mini-Blade (part #BD6400 or part... | Alcon Laboratories | HNN | ||
| Z-0521-2007 | Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill Systems (Parts 01-15400 and... | Stryker Craniomaxillofacial Division | LXH | ||
| Z-0821-2007 | Definium AMX 700 Digital mobile x-ray system, GE Healthcare 3000 North Grandview... | GE Healthcare | IZL | ||
| Z-0806-2007 | GE Discovery VCT, Volume PET-CT scanner, Model 5124069-3. | GE Healthcare | JAK | ||
| Z-0805-2007 | GE LightSpeed Xtra / GE LightSpeed RT Pro 16, Model 2374681-6, CT Scanner systems. | GE Healthcare | JAK | ||
| Z-0804-2007 | GE LightSpeed Pro 16 (100kW/80kW) Models 2357739, 2357739-3, 2357739-4, 2357739-6... | GE Healthcare | JAK | ||
| Z-0803-2007 | GE LightSpeed VCT Select / LightSpeed Pro32, Model 5126093, CT Scanner system. | GE Healthcare | JAK | ||
| Z-0713-2007 | ThermaSure Medical Device Drying Cabinet, series 1000 | Cenorin, LLC | LDS | ||
| Z-0712-2007 | ThermaSure Medical Device Drying Cabinet, series 300 | Cenorin, LLC | LDS | ||
| Z-0711-2007 | ThermaSure Medical Device Drying Cabinet, series 130 | Cenorin, LLC | LDS | ||
| Z-0802-2007 | GE LightSpeed VCT / Light Speed VCT standard configuration, Model 5124069, CT Scanner... | GE Healthcare | JAK | ||
| Z-0396-2007 | Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), Model... | Integrated Orbital Implants Inc | MQU | ||
| Z-0609-2007 | Wallstent Endoscopic Biliary Endoprosthesis 10mm x 80mm, UPN H965430600 | Boston Scientific Corporation | FGE | ||
| Z-0608-2007 | Wallstent Endoscopic Biliary Endoprosthesis 10mm x 60mm, UPN H965430500 | Boston Scientific Corporation | FGE | ||
| Z-0607-2007 | Wallstent Endoscopic Biliary Endoprosthesis 10mm x 40mm, UPN H965430400 | Boston Scientific Corporation | FGE | ||
| Z-0606-2007 | Wallstent Endoscopic Biliary Endoprosthesis 8mm x 80mm, UPN H965430300 | Boston Scientific Corporation | FGE | ||
| Z-0605-2007 | Wallstent Endoscopic Biliary Endoprosthesis 8mm x 60mm, UPN H965430200 | Boston Scientific Corporation | FGE | ||
| Z-0604-2007 | Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, UPN H965430100 | Boston Scientific Corporation | FGE | ||
| Z-0394-2007 | Recovery G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of... | Bard Peripheral Vascular Inc | DTK | ||
| Z-0393-2007 | G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of... | Bard Peripheral Vascular Inc | DTK | ||
| Z-0542-2007 | LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and... | Abbott Medical | FPA | ||
| Z-0771-2007 | Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical... | Canon Medical Systems USA, Inc. | ITX | ||
| Z-0644-2007 | BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system... | bioMerieux, Inc. | MDB | ||
| Z-0814-2007 | BacT/VIEW Software, all versions. in vitro diagnostic database software. | bioMerieux, Inc. | MDB | ||
| Z-0308-2007 | HeartStart FR2+ Defibrillator | Philips North America LLC | MKJ |