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-2227-2019 | Class I | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System)... | Edwards Lifesciences LLC | NPT | |
| Z-2226-2019 | Class I | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System)... | Edwards Lifesciences LLC | NPT | |
| Z-2225-2019 | Class I | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System)... | Edwards Lifesciences LLC | NPT | |
| Z-2224-2019 | Class I | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System)... | Edwards Lifesciences LLC | NPT | |
| Z-1905-2020 | Class II | Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559... | Medtronic Navigation, Inc | GEX | |
| Z-2358-2020 | Class II | BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended... | Becton, Dickinson and Company, BD Biosciences | PER | |
| Z-2357-2020 | Class II | BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto... | Becton, Dickinson and Company, BD Biosciences | PER | |
| Z-2356-2020 | Class II | BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system... | Becton, Dickinson and Company, BD Biosciences | PER | |
| Z-2185-2019 | Class II | VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry... | Ortho-Clinical Diagnostics, Inc. | JIX | |
| Z-2184-2019 | Class II | VITROS 5,1 FS Chemistry System, clinical chemistry analyzer | Ortho-Clinical Diagnostics, Inc. | JIX | |
| Z-2183-2019 | Class II | VITROS 5,1 FS Chemistry System, clinical chemistry analyzer | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-2182-2019 | Class II | VITROS 4600 Chemistry System, clinical chemistry analyzer | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-2181-2019 | Class II | VITROS 4600 Chemistry System, clinical chemistry analyzer | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-2180-2019 | Class II | VITROS 5600 Integrated System, clinical chemistry analyzer | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-2179-2019 | Class II | VITROS 5600 Integrated System, clinical chemistry analyzer | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-2178-2019 | Class II | VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry... | Ortho-Clinical Diagnostics, Inc. | JIX | |
| Z-2177-2019 | Class II | VITROS 350 Chemistry System, clinical chemistry analyzer | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-2176-2019 | Class II | VITROS 250AT Chemistry System, clinical chemistry analyzer | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-2175-2019 | Class II | VITROS 250 Chemistry System, clinical chemistry analyzer | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-2174-2019 | Class II | VITROS 250 Chemistry System, clinical chemistry analyzer | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-0190-2020 | Class II | GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the... | Abbott Medical | LJT | |
| Z-0189-2020 | Class II | GRIPPER Needles sold individually. Labeled as the following item descriptions: 1... | Abbott Medical | FPA | |
| Z-2364-2019 | Class II | TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The... | CooperSurgical, Inc. | IMD | |
| Z-2073-2020 | Class II | CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating... | CapsoVision, Inc. | NEZ | |
| Z-1389-2020 | Class III | LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a... | LivaNova USA, Inc. | DWE | |
| Z-0931-2020 | Class II | PediaLift Access Device, Device Identifier: B751PDLFT0 | PediaLift LLC | FMS | |
| Z-2437-2019 | Class II | SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic... | Heidelberg Engineering GmbH | OBO | |
| Z-0199-2020 | Class II | DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02 | Valeritas, Incorporated | LZG | |
| Z-0198-2020 | Class II | DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03 | Valeritas, Incorporated | LZG | |
| Z-0197-2020 | Class II | DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01 | Valeritas, Incorporated | LZG | |
| Z-0196-2020 | Class II | DEMO No Needle Corrugated Carton 30 U/D, Part Number 2260-02 | Valeritas, Incorporated | LZG | |
| Z-0195-2020 | Class II | DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03 | Valeritas, Incorporated | LZG | |
| Z-2274-2019 | Class II | SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography systems... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2273-2019 | Class II | SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography systems... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2272-2019 | Class II | SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomography systems... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2271-2019 | Class II | SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography systems... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2270-2019 | Class II | SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tomography... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2269-2019 | Class II | SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2268-2019 | Class II | SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2081-2019 | Class II | GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product... | Xcision Medical Systems, LLC | IWB | |
| Z-2091-2019 | Class II | Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System | Elekta Limited | MUJ | |
| Z-0721-2020 | Class II | Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868 | Mazor Robotics Ltd | OLO | |
| Z-0419-2020 | Class II | CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product... | Gentherm Medical, LLC | DWJ | |
| Z-0418-2020 | Class II | Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system... | Gentherm Medical, LLC | DWJ | |
| Z-0417-2020 | Class II | Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management... | Gentherm Medical, LLC | DWJ | |
| Z-2319-2019 | Class II | QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The... | Qiagen | JJH | |
| Z-2445-2019 | Class II | The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the... | Roche Diagnostics GmbH | DDR | |
| Z-2236-2019 | Class II | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151815 | Zimmer GmbH | JDI | |
| Z-2235-2019 | Class II | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814 | Zimmer GmbH | JDI | |
| Z-2234-2019 | Class II | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813 | Zimmer GmbH | JDI |