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-1408-04 | Peritoneal Lavage Kits, Model number AK-09000 | Arrow International LLC (subsidiary of Teleflex Incorporated) | GBW | ||
| Z-1065-04 | Sollux Systeme commercial tanning beds; Soleil Systems, Inc. The following models are... | Soleil Systems, Inc. | U--19 | ||
| Z-0259-05 | CXP Software Version 1.0 and 1.1 (operating software for Cytomics FD500 Cytometer. Part... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0804-05 | e-fix E20 power drive. The product is a wheelchair component/accessory. | Frank Mobility Systems, Inc. | ITI | ||
| Z-0803-05 | e-fix E19 power drive. The product is a wheelchair component/accessory. | Frank Mobility Systems, Inc. | ITI | ||
| Z-1394-04 | SMV FX-80 Nuclear Camera | GE Healthcare | IYX | ||
| Z-1393-04 | SMV FX-40 Nuclear Camera | GE Healthcare | IYX | ||
| Z-1380-04 | Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode part Number... | ZOLL Medical Corporation | DRF | ||
| Z-1101-04 | Synchron Systems Hemoglobin A1c (HbA1c) Reagent | Siemens Healthcare Diagnostics Inc. | JJY | ||
| Z-1378-04 | SYNCHRON Clinical Systems Enzyme Validator Kit | Siemens Healthcare Diagnostics Inc. | JIX | ||
| Z-0298-05 | CryoValve, Pulmonary Valve & Conduit | Artivion, Inc. | MIE | ||
| Z-1483-04 | Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm). | Datascope Corp. | DRT | ||
| Z-1473-04 | VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90... | Ortho-Clinical Diagnostics, Inc. | DCK | ||
| Z-1404-04 | Magnetom Trio MRI System, Model 7387074 | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-1403-04 | Magnetom Trio MRI System, Model 7106441 | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-1402-04 | Magnetom Sonata MRI System, Model 7106425 | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-1401-04 | Magnetom Sonata MRI System, Model 7104719 | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-1400-04 | Magnetom Sonata MRI System, Model 7388148 | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-1399-04 | Magnetom Symphony MRI System, Model 7104594 | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-1398-04 | Magnetom Symphony MRI System, Model 7106557 | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-1397-04 | Magnetom Harmony MRI System Model number 5751438 | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-1396-04 | Magnetom Harmony MRI System Model number 7106714 | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-1395-04 | Magnetom Avanto MRI System, Model 7391167 | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-1407-04 | Jackson-Pratt Reservoir, 400 mL suction reservoir; a sterile, single use only, Rx device... | Medtronic, Inc. | GBX | ||
| Z-1406-04 | Jackson-Pratt Hemaduct, 15 Fr round, full duct silicone wound drain; a sterile, single... | Medtronic, Inc. | GCY | ||
| Z-1332-04 | Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options. | Advanced Bionics LLC | MCM | ||
| Z-1377-04 | Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20 | Abbott Medical | CGX | ||
| Z-1331-04 | Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring... | Greiner Bio-One North America, Inc. | GIM | ||
| Z-1338-04 | Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a... | Baxter Healthcare Renal Div | KDI | ||
| Z-0158-06 | ICCG AC-Powered Adjustable Medical Bed | Invacare GmbH | FNL | ||
| Z-1384-04 | The Model 8540 Catheter Access Port Kit is intended for use in accessing the catheter via... | Medtronic Neuromodulation | LKK | ||
| Z-1416-04 | ADP 3.2 Adapter, non sterile reusable Model Number: 30-801-1, an accessory used with the... | Medtronic Navigation, Inc | GEI | ||
| Z-1415-04 | ADP2.1 Adapter, non-sterile reusable Model Number: 30-802-1 ,an accessory used with the... | Medtronic Navigation, Inc | GEI | ||
| Z-0007-05 | BC Thrombin Reagent . Thrombin Time Test | Siemens Healthcare Diagnostics Inc. | GJA | ||
| Z-1457-04 | BV212 Mobile X-Ray System | Philips North America LLC | IZL | ||
| Z-1456-04 | BV29 Mobile X-Ray System | Philips North America LLC | IZL | ||
| Z-1455-04 | BV26 Mobile X-Ray System | Philips North America LLC | IZL | ||
| Z-1454-04 | BV 25 Gold Mobile X-Ray System | Philips North America LLC | IZL | ||
| Z-1453-04 | BV25 Mobile X-Ray System | Philips North America LLC | IZL | ||
| Z-1311-04 | Merit MAK Mini Access Kit, 4 French (1.3mm) | Merit Medical Systems, Inc. | DRE | ||
| Z-1310-04 | Merit MAK Mini Access Kit, 4 French (1.3mm) | Merit Medical Systems, Inc. | DRE | ||
| Z-1309-04 | Merit MAK Mini Access Kit, 4 French (1.3mm) | Merit Medical Systems, Inc. | DRE | ||
| Z-1339-04 | Prolieve Thermodilatation System, model number M0068808000, labeled in part***Distributed... | Celsion Corporation | MEQ | ||
| Z-1328-04 | Stockert 70 Radio Frequency Ablation Generator | Biosense Webster Inc | DRF | ||
| Z-1121-04 | Express 2 Monorail Coronary Stent Systems (bare metal stents) - balloon expandable... | Boston Scientific Corporation | MAF | ||
| Z-0634-05 | DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725, DiaSorin... | Diasorin Inc. | CIZ | ||
| Z-0026-05 | CryoValve, Pulmonary Valve & Conduit | Artivion, Inc. | MIE | ||
| Z-1379-04 | Modular Knee Joint with Friction Brake | Bock,Otto,Orthopedic Ind,Inc | ISH | ||
| Z-0021-05 | Stryker Navigation System - Hip Module Patient Tracker, blue; Model 6007-010-000. | Stryker Corp. | HAW | ||
| Z-0020-05 | Stryker Navigation System - Hip Module Patient Tracker, green; Model 6007-005-000. | Stryker Corp. | HAW |