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-0495-2019 | Class II | Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126 | Zimmer GmbH | JWH | |
| Z-0618-2019 | Class II | VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these... | bioMerieux, Inc. | LON | |
| Z-0542-2019 | Class II | Zimmer Pressure Sentinel Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm... | Zimmer GmbH | LXH | |
| Z-0541-2019 | Class II | Zimmer Natural Nail System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Length Item... | Zimmer GmbH | LXH | |
| Z-0540-2019 | Class II | Zimmer Natural Nail System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Length Item... | Zimmer GmbH | LXH | |
| Z-0539-2019 | Class II | Zimmer Natural Nail System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm Length Item... | Zimmer GmbH | LXH | |
| Z-0538-2019 | Class II | Zimmer Natural Nail System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length Item... | Zimmer GmbH | LXH | |
| Z-0537-2019 | Class II | Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number... | Zimmer GmbH | LXH | |
| Z-0536-2019 | Class II | Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Number... | Zimmer GmbH | LXH | |
| Z-0535-2019 | Class II | Zimmer ZMS Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100... | Zimmer GmbH | LXH | |
| Z-0534-2019 | Class II | Zimmer ZMS Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm Length Item... | Zimmer GmbH | LXH | |
| Z-0533-2019 | Class II | Zimmer ZMS Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm Length Item... | Zimmer GmbH | LXH | |
| Z-0532-2019 | Class II | Zimmer M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70... | Zimmer GmbH | LXH | |
| Z-0531-2019 | Class II | Zimmer M/DN Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm... | Zimmer GmbH | LXH | |
| Z-0530-2019 | Class II | Zimmer Pressure Sentinel Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm... | Zimmer GmbH | LXH | |
| Z-0653-2019 | Class II | VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-0652-2019 | Class II | VITROS 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-0651-2019 | Class II | VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-0650-2019 | Class II | VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-0459-2019 | Class II | ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Product... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0458-2019 | Class II | ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0457-2019 | Class II | ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product... | Siemens Medical Solutions USA, Inc. | IZI | |
| Z-1937-2019 | Class II | iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name... | Siemens Healthcare Diagnostics Inc. | KQO | |
| Z-0548-2019 | Class II | Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems... | Philips North America LLC | JAK | |
| Z-0547-2019 | Class II | Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomography X-ray systems... | Philips North America LLC | JAK | |
| Z-0546-2019 | Class II | Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems... | Philips North America LLC | JAK | |
| Z-0545-2019 | Class II | Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomography X-ray... | Philips North America LLC | JAK | |
| Z-0544-2019 | Class II | Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to... | Philips North America LLC | JAK | |
| Z-0543-2019 | Class II | Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended... | Philips North America LLC | JAK | |
| Z-0515-2019 | Class II | HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue... | Eurotrol B.V. | GGM | |
| Z-0514-2019 | Class II | HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue... | Eurotrol B.V. | GGM | |
| Z-1769-2019 | Class II | Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas... | Terumo Cardiovascular Systems Corporation | DTQ | |
| Z-0727-2019 | Class II | Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number... | Volcano Corporation | OBJ | |
| Z-0726-2019 | Class II | Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number... | Volcano Corporation | OBJ | |
| Z-0581-2019 | Class II | Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile... | Leoni Fiber Optics, Inc. | GEX | |
| Z-0580-2019 | Class II | Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile... | Leoni Fiber Optics, Inc. | GEX | |
| Z-0579-2019 | Class II | Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile... | Leoni Fiber Optics, Inc. | GEX | |
| Z-0578-2019 | Class II | Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile... | Leoni Fiber Optics, Inc. | GEX | |
| Z-0577-2019 | Class II | Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve... | Leoni Fiber Optics, Inc. | GEX | |
| Z-0511-2019 | Class II | Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product... | Numed Inc | DQO | |
| Z-0510-2019 | Class II | Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product... | Numed Inc | DQO | |
| Z-0507-2019 | Class II | NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage... | NxStage Medical Inc | KPO | |
| Z-0506-2019 | Class II | NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage... | NxStage Medical Inc | KPO | |
| Z-0505-2019 | Class II | NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage... | NxStage Medical Inc | KPO | |
| Z-0504-2019 | Class II | NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage... | NxStage Medical Inc | KPO | |
| Z-0503-2019 | Class II | NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage... | NxStage Medical Inc | KPO | |
| Z-0502-2019 | Class II | NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage... | NxStage Medical Inc | KPO | |
| Z-0501-2019 | Class II | NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage... | NxStage Medical Inc | KPO | |
| Z-0500-2019 | Class II | NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. NxStage... | NxStage Medical Inc | KPO | |
| Z-0804-2019 | Class II | Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be... | Richard Wolf GmbH | KTI |