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-1456-2015 | Class I | OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE... | OriGen Biomedical, Inc. | DWF | |
| Z-1408-2015 | Class II | VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number... | Teleflex Medical | OBJ | |
| Z-1442-2015 | Class II | ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single... | Baylis Medical Co., Inc. | DQX | |
| Z-1544-2015 | Class II | Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch... | Integra Pain Management | BSP | |
| Z-1876-2017 | Class III | BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar... | Becton Dickinson & Co | JSG | |
| Z-0399-2016 | Class II | The eCareManager system. Software intended for use in data collection, storage and... | Visicu, Inc. | MSX | |
| Z-1520-2015 | Class II | AmTryke Model 1424 Community Cruiser Hand Cycle. Therapeutic tricycle. | Amtryke LLC | ION | |
| Z-1576-2015 | Class II | CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block... | B Braun Medical Inc | BRY | |
| Z-1603-2015 | Class II | Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD... | bioMerieux, Inc. | LTW | |
| Z-1602-2015 | Class II | Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD... | bioMerieux, Inc. | LTW | |
| Z-1601-2015 | Class II | Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton... | bioMerieux, Inc. | LTW | |
| Z-1689-2016 | Class II | Diamedix Is-CMV IgG Test Kit | Diamedix Corp. | LFZ | |
| Z-1613-2015 | Class II | ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch... | Handicare USA, Inc. | IKX | |
| Z-2807-2015 | Class II | EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been... | OLYMPUS Corporation of the Americas | FDT | |
| Z-1573-2015 | Class II | Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the... | Stryker Corp. | CAC | |
| Z-1572-2015 | Class II | 1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with... | Stryker Corp. | CAC | |
| Z-1571-2015 | Class II | 1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with... | Stryker Corp. | CAC | |
| Z-1570-2015 | Class II | 3/16 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar... | Stryker Corp. | CAC | |
| Z-1569-2015 | Class II | 1/4 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound... | Stryker Corp. | GCY | |
| Z-1568-2015 | Class II | 3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound... | Stryker Corp. | GCY | |
| Z-1567-2015 | Class II | 1/4 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with... | Stryker Corp. | GCY | |
| Z-1566-2015 | Class II | 1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound... | Stryker Corp. | GCY | |
| Z-1565-2015 | Class II | 1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with... | Stryker Corp. | GCY | |
| Z-1564-2015 | Class II | 1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound... | Stryker Corp. | GCY | |
| Z-1563-2015 | Class II | 3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar... | Stryker Corp. | GCY | |
| Z-1562-2015 | Class II | 3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with... | Stryker Corp. | GCY | |
| Z-1516-2015 | Class II | Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on... | PhotoMedex, Inc. | MGQ | |
| Z-2068-2015 | Class II | Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator... | Nidek Incorporated | GEX | |
| Z-2067-2015 | Class II | Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek... | Nidek Incorporated | GEX | |
| Z-1703-2015 | Class II | Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma... | Siemens Healthcare Diagnostics Inc. | GFO | |
| Z-1587-2015 | Class III | Universal Charger Product Usage: The Stryker Universal Battery Charger is designed... | Stryker Corp. | HWE | |
| Z-1501-2015 | Class II | Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG... | Sentec AG | LKD | |
| Z-1519-2015 | Class II | Light Sheer Desire Diode Laser System with XC Handpiece Accessory options. | Lumenis Ltd | GEX | |
| Z-1462-2015 | Class I | TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an... | Laax, Inc. | GDW | |
| Z-1461-2015 | Class I | TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an... | Laax, Inc. | GDW | |
| Z-1513-2015 | Class II | CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01 | CSA Medical | GEH | |
| Z-2057-2015 | Class II | Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001... | Hamilton Medical AG | CBK | |
| Z-1710-2015 | Class II | EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000... | Nidek Incorporated | LZS | |
| Z-1553-2015 | Class II | Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for... | The Anspach Effort, Inc. | HWE | |
| Z-1691-2016 | Class II | Sedecal SA Mobile Diagnost w DR x-ray system | Sedecal USA, Inc | IZL | |
| Z-2383-2015 | Class II | Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with... | Philips North America LLC | MQB | |
| Z-1622-2015 | Class II | Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests... | Roche Diagnostics GmbH | LPS | |
| Z-1365-2015 | Class II | Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models... | Medtronic, Inc. | KRA | |
| Z-1413-2015 | Class II | Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124. | Bard Peripheral Vascular Inc | DQY | |
| Z-1457-2015 | Class II | ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894. | Siemens Healthcare Diagnostics Inc. | CHI | |
| Z-1371-2015 | Class II | Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx... | Edwards Lifesciences LLC | DWF | |
| Z-1375-2015 | Class II | CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent | Becton, Dickinson and Company, BD Biosciences | MVU | |
| Z-1692-2015 | Class II | Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A. | Abbott Medical | CCK | |
| Z-1818-2015 | Class II | Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift. | Hill-Rom Inc. | FSA | |
| Z-1946-2015 | Class II | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test... | Axis-Shield Diagnostics, Ltd. | LPS |