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-1862-2008 | Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation... | Accuray Incorporated | IYE | ||
| Z-0197-2016 | Class II | GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that... | Philips North America LLC | JAK | |
| Z-1916-2008 | Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/25 cm, sterile, Boston... | Boston Scientific Corporation | GEI | ||
| Z-1915-2008 | Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/15 cm, sterile, Boston... | Boston Scientific Corporation | GEI | ||
| Z-1914-2008 | Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile, Boston... | Boston Scientific Corporation | GEI | ||
| Z-1913-2008 | Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile, Boston... | Boston Scientific Corporation | GEI | ||
| Z-1781-2008 | Philips "HeartStart Home" defibrillator, model M5068A and is sold in the US over the... | Philips North America LLC | NSA | ||
| Z-1911-2008 | Phillips Medical Systems, SureSigns VS3 Vital Signs Monitor model numbers 863071, 863072... | Philips North America LLC | MHX | ||
| Z-1780-2008 | Laerdal "HeartStart Defibrillator", model M5067A, under Laerdal brand for Laerdal Medical... | Philips North America LLC | MKJ | ||
| Z-1779-2008 | Philips defibrillator, model M5066A. Sold in the US by Philips as an OTC under the brand... | Philips North America LLC | MKJ | ||
| Z-1859-2008 | Model 35A Series Mobile Transporters is an ambulance stretcher for patient transport. | Ferno-Washington Inc | FPO | ||
| Z-1918-2008 | AneuRx AAAdvantage stent graft and the Xcelerant Delivery System with Hydro, Product... | Medtronic, Inc. | |||
| Z-1810-2008 | Lupine BR Anchor w/Orthocord TCP/PLGA Absorbable Anchor, size 2 (5 metric) Braided... | DePuy Mitek, Inc. | JDR | ||
| Z-1555-2009 | Siemens Stratus CS Acute Care Troponin I CalPak. In vitro product intended to be used... | Siemens Healthcare Diagnostics Inc. | MMI | ||
| Z-1697-2008 | Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Opaque; The product is... | Bisco Inc | EMA | ||
| Z-1696-2008 | Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Translucent; The... | Bisco Inc | EMA | ||
| Z-1777-2008 | Hill-Rom Century+ Bed Model P1400 HBSW siderail upgrade kits; accessory model numbers... | Hill-Rom Inc. | FNL | ||
| Z-2431-2008 | Ace Heat Therapy, A BD Product Up to 10 hours of Soothing Heat; Heat therapy for muscle... | Becton Dickinson & Co | IMD | ||
| Z-2193-2008 | AMPLATZER Sizing Balloon II, REF 9-SB-24. Sterile EO. AGA Medical Corporation, 682... | Abbott Medical | MJN | ||
| Z-2192-2008 | AGA Medical Corporation AMPLATZER Delivery System, 10 French, 45 Degree Angle Curve, 80... | Abbott Medical | |||
| Z-2168-2008 | Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System... | Medtronic Neuromodulation | BTA | ||
| Z-0582-2012 | Artificial Ligament Fixation Device 15MM TI NS ToggleLoc (TM) W/Continuous Maxbraid... | Biomet Sports Medicine | MBI | ||
| Z-2191-2008 | Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm catheter | Cook Vandergrift, Inc. | LJT | ||
| Z-2190-2008 | Vital Port Vascular Access System Polysulfone Petite with detached 0.9mm catheter | Cook Vandergrift, Inc. | LJT | ||
| Z-2164-2008 | FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B... | Ethicon Endo-Surgery Inc | FZT | ||
| Z-2163-2008 | ENDOPATHETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W. Utilized during... | Ethicon Endo-Surgery Inc | FZT | ||
| Z-2162-2008 | ENDOPATHETS Endoscopic Linear Cutter, TSW35. Utilized during general, gynecologic... | Ethicon Endo-Surgery Inc | FZT | ||
| Z-2161-2008 | ENDOPATHETS-Flex Endoscopic Linear Cutter, ATW35 Utilized during general, gynecologic... | Ethicon Endo-Surgery Inc | FZT | ||
| Z-0950-2009 | Architect / Aeroset Clinical Chemistry Iron/Magnesium Calibrator, List Number: 1E69-03... | Abbott Medical | JIX | ||
| Z-1813-2008 | Abbott FreeStyle Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood... | Abbott Medical | LFR | ||
| Z-0104-2009 | Zyoptix XP Microkeratome tray, Ref. #ZXP1000, which contains a number of components, one... | Bausch & Lomb Incorporated | HNO | ||
| Z-0278-2009 | S/P Orange 50g Glucose Tolerance Beverage, 10 oz glass bottles, 12 bottles/case, labeled... | NERL Diagnostics Corporation | MRV | ||
| Z-1827-2008 | MIM 4.0 and MIM 4.1 is a software package designed for use in diagnostic imaging. It is a... | MIM Software Inc | LLZ | ||
| Z-1829-2008 | GE Datex-Ohmeda Engstrom Carestation The Carestation consists of three main components: a... | GE Healthcare | CBK | ||
| Z-0103-2009 | Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183. The label shows the product is... | Bausch & Lomb Incorporated | HNO | ||
| Z-1441-2012 | OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision... | Advanced Bionics LLC | LGW | ||
| Z-2170-2008 | Ev3 Primus GPS Biliary Stent System 8 mm, 37 mm, B7, .40 mm, 5Fr, REF BXB35-08-37-75 Use... | Medtronic, Inc. | FGE | ||
| Z-2169-2008 | Ev3 Protege GPS Biliary Stent Systems 6 mm, 60 mm, 120cm, .35, 6Fr, OTW Ev3 4600 Nathan... | Medtronic, Inc. | FGE | ||
| Z-2088-2008 | TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Right, REF 71701125R. The device is... | Smith & Nephew, Inc. | HSB | ||
| Z-2087-2008 | TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Right, REF 71701120R. The device is... | Smith & Nephew, Inc. | HSB | ||
| Z-2086-2008 | TRIGEN Hind Foot Fusion Nail, 10mm X 16mm Left, REF 71701016L. The device is indicated... | Smith & Nephew, Inc. | HSB | ||
| Z-2085-2008 | TRIGEN Hind Foot Fusion Nail, 10mm X 20mm Left, REF 71701020L. The device is indicated... | Smith & Nephew, Inc. | HSB | ||
| Z-2084-2008 | TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Left, REF 71701120L. The device is indicated... | Smith & Nephew, Inc. | HSB | ||
| Z-2083-2008 | TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Left, REF 71701125L. The device is indicated... | Smith & Nephew, Inc. | HSB | ||
| Z-2082-2008 | TRIGEN Hind Foot Fusion Nail, 10mm X 25mm Left, REF 71701025L. The device is indicated... | Smith & Nephew, Inc. | HSB | ||
| Z-2287-2008 | Piccolo Chemistry Analyzer software version 6.121 with Electrolyte Panel Lot #8041AC5... | Abaxis Inc | JLB | ||
| Z-2286-2008 | Piccolo Chemistry Analyzer software version 6.121 with Comprehensive Metabolic Lot... | Abaxis Inc | JLB | ||
| Z-1799-2008 | Contour Genesis Aspiration Tubing, 12'; Part Number CG-PT-5558; distributed by Mentor... | Mentor | BYY | ||
| Z-1798-2008 | Contour Genesis Inf/IR Tubing; Part Number CG-UT; distributed by Mentor Texas, LP... | Mentor | FPK | ||
| Z-1797-2008 | Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T; distributed by Mentor... | Mentor | FPK |