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-1518-2017 | Class II | Raindrop Near Vision Inlay, Model# RD1-1 | Revision Optics Inc | LQE | |
| Z-2179-2017 | Class II | Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems | GE Healthcare | IXR | |
| Z-2163-2017 | Class II | CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for delivery... | Halyard Health | KNT | |
| Z-2162-2017 | Class II | CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; Product Usage: CORFLO... | Halyard Health | KNT | |
| Z-2686-2017 | Class II | Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography... | Siemens Medical Solutions USA, Inc. | IZI | |
| Z-1538-2017 | Class I | HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is... | HeartWare, Inc. | DSQ | |
| Z-2161-2017 | Class II | CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm); Product... | Halyard Health | KNT | |
| Z-1872-2017 | Class II | PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical... | Cp Medical | GAM | |
| Z-1869-2017 | Class II | Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls... | Elcam Medical, Inc. | FMG | |
| Z-1537-2017 | Class II | ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1244-2017 | Class II | Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706 | Smith & Nephew, Inc. | HAB | |
| Z-1243-2017 | Class II | Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705 | Smith & Nephew, Inc. | HAB | |
| Z-1242-2017 | Class II | Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704 | Smith & Nephew, Inc. | HAB | |
| Z-1241-2017 | Class II | Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703 | Smith & Nephew, Inc. | HAB | |
| Z-1240-2017 | Class II | Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702 | Smith & Nephew, Inc. | HAB | |
| Z-1239-2017 | Class II | Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701 | Smith & Nephew, Inc. | HAB | |
| Z-2109-2017 | Class II | Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System... | Canon Medical Systems USA, Inc. | OWB | |
| Z-1471-2017 | Class II | VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660... | Ortho-Clinical Diagnostics, Inc. | JIH | |
| Z-1494-2017 | Class II | Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek... | Nidek Incorporated | LZS | |
| Z-1687-2017 | Class II | Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl... | Respironics, Inc. | MNT | |
| Z-1393-2017 | Class II | TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film... | Cook Incorporated | KRA | |
| Z-1392-2017 | Class II | Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film... | Cook Incorporated | DYB | |
| Z-1391-2017 | Class II | Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a... | Cook Incorporated | DYB | |
| Z-1390-2017 | Class II | Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable... | Cook Incorporated | DYB | |
| Z-1389-2017 | Class II | Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film... | Cook Incorporated | KGZ | |
| Z-1388-2017 | Class II | Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film... | Cook Incorporated | DYB | |
| Z-1387-2017 | Class II | Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film... | Cook Incorporated | DYB | |
| Z-2166-2017 | Class II | SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE... | Siemens Healthcare Diagnostics Inc. | CDZ | |
| Z-1383-2017 | Class II | PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part... | Synthes (USA) Products LLC | LXH | |
| Z-1481-2017 | Class II | 882478: BrightView X designed for single or dual detector nuclear imaging accommodating a... | Philips North America LLC | KPS | |
| Z-1480-2017 | Class II | 882480: BrightView designed for single or dual detector nuclear imaging accommodating a... | Philips North America LLC | KPS | |
| Z-1479-2017 | Class II | 882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual... | Philips North America LLC | KPS | |
| Z-1890-2017 | Class II | MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are... | Medtronic, Inc. | ||
| Z-1401-2017 | Class II | AngioJet Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular... | Boston Scientific Corporation | MCX | |
| Z-1233-2017 | Class II | Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx... | Degania Silicone, Inc. | GBX | |
| Z-1406-2017 | Class II | A-series lift - A625 Manual Part No. 324117. Prism Medical. | Handicare USA, Inc. | FSA | |
| Z-1238-2017 | Class III | Daavlin Aquex (DAAV1000) | Hidrex GmbH | EGJ | |
| Z-1237-2017 | Class III | Hidrex USA DVP1000 | Hidrex GmbH | EGJ | |
| Z-1384-2017 | Class II | iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720... | Siemens Healthcare Diagnostics Inc. | KQO | |
| Z-1535-2017 | Class II | LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only... | TearScience, Inc. | ORZ | |
| Z-1236-2017 | Class III | Hidrex USA DP450 | Hidrex GmbH | EGJ | |
| Z-1253-2017 | Class II | EliA Sample Diluent, Article number, 83-1023-01 | Phadia AB | NHX | |
| Z-1405-2017 | Class II | A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical. | Handicare USA, Inc. | FSA | |
| Z-0084-2018 | Class II | BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood... | Becton Dickinson & Co | JKA | |
| Z-1683-2017 | Class II | Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a... | National Biological Corp. | FTC | |
| Z-1456-2017 | Class II | VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW... | Maquet Cardiovascular LLC | GEI | |
| Z-1836-2017 | Class II | Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk... | Medtronic, Inc. | GEI | |
| Z-1693-2017 | Class II | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code... | Baxter Healthcare Corporation | FRN | |
| Z-1463-2017 | Class II | The ABL800 Model#:All | Radiometer America, Inc | CHL | |
| Z-1462-2017 | Class II | ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases... | Radiometer America, Inc | CHL |