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-1091-2017 | Class II | Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a... | Merge Healthcare Incorporated | DQK | |
| Z-1046-2017 | Class II | Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to... | Merge Healthcare Incorporated | LLZ | |
| Z-1246-2017 | Class II | Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye... | Merge Healthcare Incorporated | NFJ | |
| Z-0729-2017 | Class II | Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store... | Merge Healthcare Incorporated | LLZ | |
| Z-0726-2017 | Class II | Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed... | Merge Healthcare Incorporated | LLZ | |
| Z-0599-2017 | Class II | Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication... | Merge Healthcare Incorporated | LLZ | |
| Z-1668-2016 | Class II | ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part #... | The Anspach Effort, Inc. | ERL | |
| Z-1559-2016 | Class II | Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number... | Becton Dickinson & Co | JSI | |
| Z-1667-2016 | Class II | ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part #... | The Anspach Effort, Inc. | ERL | |
| Z-1370-2016 | Class II | Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating... | Boston Scientific Corporation | DQX | |
| Z-1871-2016 | Class II | Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single... | Skytron, LLC | FQO | |
| Z-1566-2016 | Class II | PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure... | Stryker Corp. | HIF | |
| Z-1380-2016 | Class II | EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC... | Philips North America LLC | IYN | |
| Z-1502-2016 | Class II | The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit... | GE Healthcare | MHX | |
| Z-1937-2016 | Class II | Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care... | Becton Dickinson & Co | FMF | |
| Z-1614-2016 | Class I | NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s... | Monteris Medical Corp | GEX | |
| Z-1936-2016 | Class II | Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care... | Becton Dickinson & Co | FMF | |
| Z-1833-2016 | Class II | The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand... | Abbott Medical | FRN | |
| Z-1832-2016 | Class II | The Plum 360 is a large volume infuser capable of delivering fluids for a variety of... | Abbott Medical | FRN | |
| Z-1671-2016 | Class II | AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS... | AB Sciex, LLC | DOP | |
| Z-1568-2016 | Class II | EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000)... | Intuitive Surgical, Inc. | NAY | |
| Z-1564-2016 | Class II | Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology... | Hansen Medical, Inc. | DXX | |
| Z-2538-2016 | Class II | Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to... | Teleflex Medical | HCF | |
| Z-1886-2016 | Class II | Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1885-2016 | Class II | Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1865-2016 | Class II | The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in... | Abbott Medical | CHP | |
| Z-2372-2016 | Class II | Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce... | Philips North America LLC | JAK | |
| Z-2371-2016 | Class II | Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional... | Philips North America LLC | JAK | |
| Z-2370-2016 | Class II | Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce... | Philips North America LLC | JAK | |
| Z-2369-2016 | Class II | Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional... | Philips North America LLC | JAK | |
| Z-2368-2016 | Class II | Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to produce... | Philips North America LLC | JAK | |
| Z-2367-2016 | Class II | Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to produce... | Philips North America LLC | JAK | |
| Z-2366-2016 | Class II | Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional... | Philips North America LLC | JAK | |
| Z-1573-2016 | Class II | NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography... | Neusoft Medical Systems Co., Ltd. | JAK | |
| Z-1921-2016 | Class II | Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid... | Remel Inc | JTT | |
| Z-1522-2016 | Class II | CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN... | Abbott Medical | GKZ | |
| Z-1606-2016 | Class II | Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and... | CareFusion 303, Inc | FRN | |
| Z-2213-2017 | Class III | Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used... | Neogen Culture Media | JSG | |
| Z-1704-2016 | Class II | Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for... | Leica Microsystems, Inc. | NJT | |
| Z-1843-2016 | Class II | AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple... | Medscience Research Group, Inc. | LDH | |
| Z-1350-2016 | Class II | SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1342-2016 | Class I | Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The... | Boston Scientific Corporation | DXE | |
| Z-1378-2016 | Class II | Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip... | Stryker Corp. | LFL | |
| Z-1525-2016 | Class II | Self-Cath Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product... | MEDLINE INDUSTRIES, LP - Northfield | EZL | |
| Z-1702-2016 | Class II | AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx... | Boston Scientific Corporation | DWE | |
| Z-1701-2016 | Class II | Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only... | Boston Scientific Corporation | DWE | |
| Z-1870-2016 | Class II | General Surgery Pack, part number 006880-3. This is a custom convenience surgical... | Windstone Medical Packaging, Inc. | LRS | |
| Z-1869-2016 | Class II | Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenience surgical... | Windstone Medical Packaging, Inc. | LRS | |
| Z-1868-2016 | Class II | Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience... | Windstone Medical Packaging, Inc. | LRS | |
| Z-1517-2016 | Class II | GDC-18 360 11MM X 30CM Detachable Coil Sterile; Model number: M0033471020SR0 Neurology... | Stryker Corp. | HCG |