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-1143-2019 | Class II | Brilliance 64, 728231 Product Usage: Computed Tomography X-ray systems intended to... | Philips North America LLC | JAK | |
| Z-1142-2019 | Class II | Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to... | Philips North America LLC | JAK | |
| Z-2886-2018 | Class II | Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2744-2018 | Class II | AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a)... | ConvaTec Limited | FEN | |
| Z-0801-2019 | Class II | Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following... | Radiometer America, Inc | CHL | |
| Z-2828-2018 | Class II | Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam... | Cypress Medical Products LLC | LYZ | |
| Z-2734-2018 | Class II | Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed... | Water Pik, Inc. | JET | |
| Z-2736-2018 | Class II | iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response... | Hudson Scientific LLC | GZO | |
| Z-2292-2019 | Class II | Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic... | Luminex Corporation | OOI | |
| Z-0194-2019 | Class II | Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0193-2019 | Class II | Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0192-2019 | Class II | Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0191-2019 | Class II | Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0190-2019 | Class II | Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0189-2019 | Class II | Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-2838-2018 | Class II | 3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to... | Siemens Medical Solutions USA, Inc. | IYB | |
| Z-2837-2018 | Class II | 3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The... | Siemens Medical Solutions USA, Inc. | IYB | |
| Z-2839-2018 | Class II | Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head... | FUJIFILM Healthcare Americas Corporation | JAK | |
| Z-2881-2018 | Class II | Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product... | Back 2 Basics Direct, LLC | NKB | |
| Z-2746-2018 | Class II | MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated... | Mevion Medical Systems, Inc. | LHN | |
| Z-2975-2018 | Class II | Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld... | Quasar Bio-Tech Inc | OHS | |
| Z-2974-2018 | Class II | Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld... | Quasar Bio-Tech Inc | OHS | |
| Z-2973-2018 | Class II | Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld... | Quasar Bio-Tech Inc | OHS | |
| Z-2497-2018 | Class II | RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2595-2018 | Class II | MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD Infinity XR2... | Integra LifeSciences Corporation | GDJ | |
| Z-2594-2018 | Class II | MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD Infinity... | Integra LifeSciences Corporation | GDJ | |
| Z-2593-2018 | Class II | MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E The MAYFIELD Infinity XR2... | Integra LifeSciences Corporation | GDJ | |
| Z-2592-2018 | Class II | MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD Infinity XR2 Base Unit... | Integra LifeSciences Corporation | GDJ | |
| Z-2962-2018 | Class II | Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS... | Medrad, Inc. | JAK | |
| Z-2960-2018 | Class II | Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS... | Medrad, Inc. | JAK | |
| Z-2961-2018 | Class II | Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer... | Medrad, Inc. | JAK | |
| Z-2590-2018 | Class II | Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001... | Envoy Medical Corporation | OAF | |
| Z-2738-2018 | Class II | The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION... | GE Healthcare | CBK | |
| Z-2005-2020 | Class II | Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable... | Genicon, Inc. | GCJ | |
| Z-1412-2019 | Class II | Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system... | Elekta Instrument AB | IWB | |
| Z-0230-2019 | Class II | BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The... | bioMerieux, Inc. | MDB | |
| Z-0229-2019 | Class II | BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The... | bioMerieux, Inc. | MDB | |
| Z-0228-2019 | Class II | BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The... | bioMerieux, Inc. | MDB | |
| Z-2868-2018 | Class II | EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2867-2018 | Class II | EasyDiagnost Eleva DRF (Stitching Patient Support) 706032 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2866-2018 | Class II | DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2865-2018 | Class II | DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2864-2018 | Class II | DigitalDiagnost Upgrades (Stitching Patient Support) 712083 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2863-2018 | Class II | DigitalDiagnost Single Detector (Stitching Patient Support) 712020 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2862-2018 | Class II | DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2861-2018 | Class II | DigitalDiagnost Release 3 (Stitching Patient Support) 712025 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2860-2018 | Class II | DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2859-2018 | Class II | DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2858-2018 | Class II | DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2857-2018 | Class II | DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052 | Philips Medical Systems DMC GmbH | MQB |