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-1796-2008 | Psi-Tec Syringe Pump Infiltration Tubing, 10'; 10/box; Part Number PT-INF-T; distributed... | Mentor | FPK | ||
| Z-1795-2008 | Irrigation Tubing, 25'; Part Number 5120-25; distributed by Mentor Texas, LP, Irving, TX... | Mentor | FPK | ||
| Z-1794-2008 | Y Tubing Set, 9'; 10/box; Part Number LAM-Y; distributed by Mentor Texas, LP, Irving, TX... | Mentor | FPK | ||
| Z-1793-2008 | Lamis Tubing Set, 9'; 10/box; Part Number LAM-TUBING; distributed by Mentor Texas, LP... | Mentor | FPK | ||
| Z-1792-2008 | Hi-Vac Tubing, 8'; 10/box; Part Number B-5558; distributed by Mentor Texas, LP, Irving... | Mentor | FPK | ||
| Z-1791-2008 | Autofuse Tubing, DIS SI; Part Number AFTU-DS; distributed by Mentor Texas, LP, Irving, TX... | Mentor | FPK | ||
| Z-1790-2008 | Psi-Tec Tubing, 12'; 10/box; Part Number PT-5558; distributed by Mentor Texas, LP... | Mentor | FPK | ||
| Z-1811-2008 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Cardiac Probe Gasper Instrument... | Intuitive Surgical, Inc. | NAY | ||
| Z-0207-2009 | Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3. Sunquest Laboratory Information... | CliniSys, Inc | JQP | ||
| Z-1784-2008 | PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine... | Spinal Concepts, Inc. | NKB | ||
| Z-1783-2008 | BIOMET EZLoc 9-10mm TM Femoral Fixation, Catalog Number 904781. The Ezloc Is indicated... | Biomet Sports Medicine | MBI | ||
| Z-1782-2008 | BIOMET EZLoc 7-8mm TM Femoral Fixation, Catalog Number 904780. The Ezloc Is indicated... | Biomet Sports Medicine | MBI | ||
| Z-0446-2009 | Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0445-2009 | Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-1871-2008 | Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model numbers 01-0575, 01-0576 and... | Biomet Microfixation | EMM | ||
| Z-1906-2008 | Physio-Control LIFEPAK 20e defibrillator/monitor, sold internationally only, is... | Physio Control, Inc. | LDD | ||
| Z-1905-2008 | Physio-Control LIFEPAK 20 defibrillator/monitor is indicated for the termination of... | Physio Control, Inc. | LDD | ||
| Z-1904-2008 | Physio-Control LIFEPAK 12 defibrillator/monitor is indicated for the termination of... | Physio Control, Inc. | LDD | ||
| Z-1930-2009 | Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP). In vitro... | Siemens Healthcare Diagnostics Inc. | DCN | ||
| Z-1701-2008 | Custom Kit, REF: K05-00843, Revision L, Sterile, Merit Medical Systems, Inc., South... | Merit Medical Systems, Inc. | DQO | ||
| Z-1700-2008 | Custom Kit, Custom Angiographic Kit, REF: K05-YS1032, Revision A, Sterile, Merit Medical... | Merit Medical Systems, Inc. | DQO | ||
| Z-1699-2008 | Custom Kit, Custom Angiographic Kit, REF: K05-YS1025, Sterile, Merit Medical Systems... | Merit Medical Systems, Inc. | DQO | ||
| Z-1706-2008 | OEC 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900 Elite... | GE Healthcare | JAA | ||
| Z-1705-2008 | OEC 9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC FluoroTrak... | GE Healthcare | JAA | ||
| Z-2174-2008 | Model 8731SC Intrathecal Catheter Medtronic Inc., Minneapolis, MN 55432 A part of the... | Medtronic Neuromodulation | LKK | ||
| Z-2173-2008 | Model 8709SC Indura 1P One-Piece Intrathecal Catheter Medtronic Inc., Minneapolis, MN... | Medtronic Neuromodulation | LKK | ||
| Z-2172-2008 | Model 8596SC Intrathecal Catheter Pump Segment Revision Kit Medtronic Inc., Minneapolis... | Medtronic Neuromodulation | LKK | ||
| Z-2171-2008 | Medtronic 8578 Sutureless Pump Connector Revision Kit Medtronic Inc., Minneapolis, MN... | Medtronic Neuromodulation | LKK | ||
| Z-2151-2008 | Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-E For In Vitro Diagnostic... | Genzyme Corporation | CHI | ||
| Z-2150-2008 | Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-D For In Vitro Diagnostic... | Genzyme Corporation | CHI | ||
| Z-2149-2008 | Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-C For In Vitro Diagnostic... | Genzyme Corporation | CHI | ||
| Z-2148-2008 | Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-B For In Vitro Diagnostic... | Genzyme Corporation | CHI | ||
| Z-1820-2008 | Allez Spine Del Mar Pedicle Screw System: IT-FN 1007, Del Mar Sterilization Tray (Part... | Allez Spine, LLC | NKB | ||
| Z-1819-2008 | Allez Spine Laguna Pedicle Screw System: IT-FN1001, Laguna Sterilization Tray # 1 (Part... | Allez Spine, LLC | MNI | ||
| Z-1828-2008 | Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media... | Mallinckrodt, Inc. | DXT | ||
| Z-1444-2009 | Sybaritic, NannoLight MP50. Model Numbers and Description: 1.) 304207-MP 220... | Sybaritic, Inc. | GEX | ||
| Z-1789-2008 | Keramos Replacement Polyethylene Liner, 64mm; Cat. #496-28-064; Sterile, Single Use... | Encore Medical, LP | MRA | ||
| Z-1788-2008 | Keramos Replacement Polyethylene Liner, 60mm; Cat. #496-28-060; Sterile, Single Use... | Encore Medical, LP | MRA | ||
| Z-1787-2008 | Keramos Replacement Polyethylene Liner, 56mm; Cat. #496-28-056; Sterile, Single Use... | Encore Medical, LP | MRA | ||
| Z-1786-2008 | Keramos Replacement Polyethylene Liner, 52mm; Cat. #496-28-052; Sterile, Single Use... | Encore Medical, LP | MRA | ||
| Z-1785-2008 | Keramos Replacement Polyethylene Liner, 48mm; Cat. #496-28-048; Sterile, Single Use... | Encore Medical, LP | MRA | ||
| Z-1910-2008 | USCT5D, Pro-PICC CT 5F x 55 cm Dual Lumen. infusion catheter insertion kit. The product... | Medical Components, Inc. | LJS | ||
| Z-1909-2008 | CMS-MST572 5F insertion kit with 5 cm tearaway. The product is shipped 10 kits per box... | Medical Components, Inc. | DQX | ||
| Z-1776-2008 | Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL... | Pride Mobility Products Corp | ITI | ||
| Z-2139-2008 | CELL-DYN Sapphire Hematology Analyzer, List number 08H00-01, LIS/ Middleware Interface... | Abbott Medical | GKZ | ||
| Z-0001-2009 | NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body... | Philips North America LLC | JAA | ||
| Z-1809-2008 | Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02159A, Sterile, Merit Medical Systems, Inc... | Merit Medical Systems, Inc. | KDD | ||
| Z-1808-2008 | Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, Sterile, Merit Medical Systems, Inc... | Merit Medical Systems, Inc. | KDD | ||
| Z-1648-2008 | Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose... | Genzyme Corporation | |||
| Z-1647-2008 | Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose... | Genzyme Corporation |