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-2756-2015 | Class II | Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model... | Intuitive Surgical, Inc. | NAY | |
| Z-2755-2015 | Class II | Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers... | Intuitive Surgical, Inc. | NAY | |
| Z-2754-2015 | Class II | Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers... | Intuitive Surgical, Inc. | NAY | |
| Z-2753-2015 | Class II | Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers... | Intuitive Surgical, Inc. | NAY | |
| Z-2752-2015 | Class II | Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers... | Intuitive Surgical, Inc. | NAY | |
| Z-2751-2015 | Class II | Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000); Model... | Intuitive Surgical, Inc. | NAY | |
| Z-2750-2015 | Class II | Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers... | Intuitive Surgical, Inc. | NAY | |
| Z-2742-2015 | Class II | CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the... | Terumo Cardiovascular Systems Corporation | DRY | |
| Z-2424-2015 | Class II | IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product... | International Biophysics Corp. | DWS | |
| Z-2423-2015 | Class II | IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40... | International Biophysics Corp. | DWS | |
| Z-2422-2015 | Class II | IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a... | International Biophysics Corp. | DTS | |
| Z-2449-2015 | Class II | CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently... | Eastman Kodak Company | KPR | |
| Z-0137-2016 | Class II | Thinflap System Case The cases hold surgical instrumentation in place during handling and... | Biomet Microfixation | GWO | |
| Z-0136-2016 | Class II | Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and... | Biomet Microfixation | GWO | |
| Z-2490-2015 | Class II | 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL... | Trilliant Surgical LLC | HRS | |
| Z-2537-2015 | Class II | MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight... | Medtronic, Inc. | NGT | |
| Z-2536-2015 | Class II | MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved... | Medtronic, Inc. | NGT | |
| Z-2535-2015 | Class II | MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved... | Medtronic, Inc. | NGT | |
| Z-2534-2015 | Class II | Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety... | Medtronic, Inc. | NGT | |
| Z-2533-2015 | Class II | Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety... | Medtronic, Inc. | NGT | |
| Z-2532-2015 | Class II | Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety... | Medtronic, Inc. | NGT | |
| Z-2531-2015 | Class II | Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety... | Medtronic, Inc. | NGT | |
| Z-2530-2015 | Class II | Mahurkar" Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* Safety... | Medtronic, Inc. | NGT | |
| Z-2529-2015 | Class II | Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety... | Medtronic, Inc. | NGT | |
| Z-2528-2015 | Class II | Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC*... | Medtronic, Inc. | NGT | |
| Z-2527-2015 | Class II | Mahurkar Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety Components... | Medtronic, Inc. | NGT | |
| Z-2526-2015 | Class II | Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety... | Medtronic, Inc. | NGT | |
| Z-2465-2015 | Class II | Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non... | TORNIER Inc. | HSN | |
| Z-2731-2015 | Class I | Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF... | SynCardia Systems LLC | LOZ | |
| Z-2525-2015 | Class II | Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product... | Medtronic, Inc. | NGT | |
| Z-1896-2017 | Class II | SurFlo IV Catheter | Terumo Medical Corp. | FOZ | |
| Z-0149-2016 | Class II | Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number... | Natus Medical Incorporated | LBI | |
| Z-0129-2016 | Class II | Owandy Radiology I -MAX Touch 3D X-ray | Acteon, Inc. | OAS | |
| Z-0128-2016 | Class II | Villa Sistemi Rotograph EVO 3D X-ray | Acteon, Inc. | MUH | |
| Z-2744-2015 | Class II | Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate... | Highridge Medical, LLC | KWQ | |
| Z-2812-2015 | Class II | ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-2779-2015 | Class III | The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The... | Leica Microsystems, Inc. | IEO | |
| Z-2440-2015 | Class II | ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to... | Brainlab, Inc. | IYE | |
| Z-2775-2015 | Class II | Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software... | Medrad, Inc. | DXT | |
| Z-2743-2015 | Class I | PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL... | Microport Orthopedics Inc. | MBL | |
| Z-2781-2015 | Class II | NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to... | Salter Labs | CAF | |
| Z-2761-2015 | Class II | Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The... | Medivators Inc | KDI | |
| Z-2826-2015 | Class II | Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System Product... | Ferno-Washington Inc | FPO | |
| Z-2458-2015 | Class II | Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit... | MEDLINE INDUSTRIES, LP - Northfield | OFF | |
| Z-2776-2015 | Class II | Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile... | Edwards Lifesciences LLC | DXO | |
| Z-2769-2015 | Class II | Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant... | Applied Medical Resources Corp | GEI | |
| Z-2738-2015 | Class II | 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number... | Trilliant Surgical LLC | HRS | |
| Z-2437-2015 | Class II | Siemens Intevo Series system, a radiological imaging system that is a combination of a... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2436-2015 | Class II | Siemens Symbia T Series, a radiological imaging system that is a combination of a single... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2435-2015 | Class II | Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2... | Siemens Medical Solutions USA, Inc. | KPS |