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-0427-2016 | Class II | MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application (Middleware)... | bioMerieux, Inc. | JQP | |
| Z-0426-2016 | Class II | MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application (Middleware)... | bioMerieux, Inc. | JQP | |
| Z-0425-2016 | Class II | MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application (Middleware)... | bioMerieux, Inc. | JQP | |
| Z-0716-2016 | Class II | Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for... | Philips North America LLC | OWB | |
| Z-0715-2016 | Class II | Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g... | Philips North America LLC | OWB | |
| Z-0714-2016 | Class II | Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular and... | Philips North America LLC | OWB | |
| Z-0713-2016 | Class II | Allura Xper FD20/20; Model Number: 722038 Dedicated vascular and neurovascular imaging... | Philips North America LLC | OWB | |
| Z-0712-2016 | Class II | Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated vascular and... | Philips North America LLC | OWB | |
| Z-0711-2016 | Class II | Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and... | Philips North America LLC | OWB | |
| Z-0710-2016 | Class II | Allura Xper FD20 OR Table; Model Numbers: 722035 722023 Dedicated vascular and... | Philips North America LLC | OWB | |
| Z-0709-2016 | Class II | UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use on human... | Philips North America LLC | OWB | |
| Z-0708-2016 | Class II | UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to... | Philips North America LLC | OWB | |
| Z-0707-2016 | Class II | Allura Xper FD20; Model Numbers: 722028 722012 722006 Dedicated vascular and... | Philips North America LLC | OWB | |
| Z-0706-2016 | Class II | Allura Xper FD20/15; Model Numbers: 722058 Dedicated vascular and neurovascular imaging... | Philips North America LLC | OWB | |
| Z-0705-2016 | Class II | Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging... | Philips North America LLC | OWB | |
| Z-0704-2016 | Class II | Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and... | Philips North America LLC | OWB | |
| Z-0703-2016 | Class II | Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and... | Philips North America LLC | OWB | |
| Z-0702-2016 | Class II | Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002... | Philips North America LLC | OWB | |
| Z-0643-2016 | Class II | VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-0642-2016 | Class II | VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-0641-2016 | Class II | VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-0640-2016 | Class II | VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-0765-2016 | Class II | Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications. | Philips North America LLC | OWB | |
| Z-0764-2016 | Class II | Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications. | Philips North America LLC | OWB | |
| Z-0660-2016 | Class I | Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q... | Abbott Medical | LWS | |
| Z-1246-2016 | Class II | Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical... | The Anspach Effort, Inc. | GDO | |
| Z-0377-2016 | Class II | AMS 4675 Angio Pack. For use in a general clinical procedure. | Windstone Medical Packaging, Inc. | KDD | |
| Z-0376-2016 | Class II | AMS 4674 Custom Pack. For use in a general clinical procedure. | Windstone Medical Packaging, Inc. | KDD | |
| Z-0292-2016 | Class II | ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact... | Leonhard Lang GmbH | DRX | |
| Z-0375-2016 | Class II | Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile... | Synthes (USA) Products LLC | HSB | |
| Z-0323-2016 | Class II | 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of... | Synthes (USA) Products LLC | HWC | |
| Z-0563-2016 | Class II | Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical... | Hill-Rom Inc. | FSY | |
| Z-0394-2016 | Class I | OmniPod, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The... | Insulet Corporation | LZG | |
| Z-0393-2016 | Class I | OmniPod, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The... | Insulet Corporation | LZG | |
| Z-0481-2016 | Class II | Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0391-2016 | Class II | RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only... | BioHorizons Implant Systems Inc | DZE | |
| Z-0334-2016 | Class II | BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and... | Becton, Dickinson and Company, BD Biosciences | MVU | |
| Z-0177-2018 | Class II | Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is... | Zimmer GmbH | OLO | |
| Z-0549-2016 | Class II | Ingenuity CT Computed Tomography X-ray system | Philips North America LLC | JAK | |
| Z-0548-2016 | Class II | Ingenuity Core 128 Computed Tomography X-ray system | Philips North America LLC | JAK | |
| Z-0547-2016 | Class II | Ingenuity Core Computed Tomography X-ray system | Philips North America LLC | JAK | |
| Z-0546-2016 | Class II | Brilliance iCT SP Computed Tomography X-ray system | Philips North America LLC | JAK | |
| Z-0545-2016 | Class II | Brilliance iCT Computed Tomography X-ray system | Philips North America LLC | JAK | |
| Z-0544-2016 | Class II | Brilliance 64 Computed Tomography X-ray system | Philips North America LLC | JAK | |
| Z-0337-2016 | Class II | NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4 | NxStage Medical Inc | KDI | |
| Z-0336-2016 | Class II | NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis. | NxStage Medical Inc | KDI | |
| Z-0335-2016 | Class II | NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis. | NxStage Medical Inc | KDI | |
| Z-0327-2016 | Class II | NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A | NxStage Medical Inc | KDI | |
| Z-0326-2016 | Class II | NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5 | NxStage Medical Inc | KDI | |
| Z-0338-2016 | Class II | rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW... | Masimo Corporation | DQA |