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-2524-2018 | Class II | ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-2375-2018 | Class II | Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 9... | Zimmer GmbH | LPH | |
| Z-2374-2018 | Class II | Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 7.5... | Zimmer GmbH | LPH | |
| Z-2373-2018 | Class II | Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 22.5... | Zimmer GmbH | LPH | |
| Z-2372-2018 | Class II | Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 20... | Zimmer GmbH | LPH | |
| Z-2371-2018 | Class II | Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 17.5... | Zimmer GmbH | LPH | |
| Z-2370-2018 | Class II | Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 16.25... | Zimmer GmbH | LPH | |
| Z-2369-2018 | Class II | Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 15... | Zimmer GmbH | LPH | |
| Z-2368-2018 | Class II | Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 13.5... | Zimmer GmbH | LPH | |
| Z-2367-2018 | Class II | Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 12.5... | Zimmer GmbH | LPH | |
| Z-2366-2018 | Class II | Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 11... | Zimmer GmbH | LPH | |
| Z-2365-2018 | Class II | Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 10... | Zimmer GmbH | LPH | |
| Z-2364-2018 | Class II | Zimmer M/L Taper Hip Prosthesis With Kinectiv Technology Cementless, Size 6... | Zimmer GmbH | LPH | |
| Z-2363-2018 | Class II | Zimmer M/L Taper Hip Prosthesis With Kinectiv Technology Cementless, Size 5... | Zimmer GmbH | LPH | |
| Z-2362-2018 | Class II | Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711-004-10 | Zimmer GmbH | LPH | |
| Z-2361-2018 | Class II | Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40 | Zimmer GmbH | LPH | |
| Z-2441-2018 | Class II | Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope | Carl Zeiss Microscopy, LLC | RGW | |
| Z-0089-2019 | Class II | Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform... | Implant Direct Sybron Manufacturing LLC | NDP | |
| Z-2248-2018 | Class II | Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2596-2018 | Class II | EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use. | Qiagen | JJH | |
| Z-0010-2019 | Class II | ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a... | Radiometer America, Inc | JJE | |
| Z-2526-2018 | Class II | Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-2525-2018 | Class II | AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an... | Siemens Medical Solutions USA, Inc. | JAA | |
| Z-2340-2018 | Class II | GE Healthcare CARESCAPE Monitor B650 | GE Healthcare Finland Oy | DQK | |
| Z-2432-2018 | Class II | Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a)... | Medtronic Neuromodulation | LGW | |
| Z-2431-2018 | Class II | Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b)... | Medtronic Neuromodulation | LGW | |
| Z-0608-2019 | Class II | Discovery NM/CT 670 Pro, model 5376204-70-54 | GE Healthcare | KPS | |
| Z-0607-2019 | Class II | Discovery NM/CT 670 ES, model 5376204-70-57 | GE Healthcare | KPS | |
| Z-0606-2019 | Class II | Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing... | GE Healthcare | KPS | |
| Z-0359-2019 | Class III | Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software... | Siemens Healthcare Diagnostics Inc. | JQP | |
| Z-0358-2019 | Class III | Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part... | Siemens Healthcare Diagnostics Inc. | JQP | |
| Z-0357-2019 | Class III | Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95343... | Siemens Healthcare Diagnostics Inc. | JQP | |
| Z-0356-2019 | Class III | Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckman Coulter... | Siemens Healthcare Diagnostics Inc. | JQP | |
| Z-0355-2019 | Class III | Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No... | Siemens Healthcare Diagnostics Inc. | JQP | |
| Z-0354-2019 | Class III | Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman... | Siemens Healthcare Diagnostics Inc. | JQP | |
| Z-2587-2018 | Class II | CT Goldseal BrightSpeed 16 PWR TIO 2 YR | GE Healthcare | JAK | |
| Z-2586-2018 | Class II | Optima CT 540 | GE Healthcare | JAK | |
| Z-2585-2018 | Class II | Optima CT 520 | GE Healthcare | JAK | |
| Z-2584-2018 | Class II | Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID... | GE Healthcare | JAK | |
| Z-2583-2018 | Class II | CT Goldseal Optima CT 600 | GE Healthcare | JAK | |
| Z-2582-2018 | Class II | Revolution CT 160 1.5D STD WAUK | GE Healthcare | JAK | |
| Z-2581-2018 | Class II | Discovery RT labeled as: a. MID BJG; b. HVY BJG | GE Healthcare | JAK | |
| Z-2580-2018 | Class II | Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring | GE Healthcare | KPS | |
| Z-2579-2018 | Class II | Discovery MI Digital Ready | GE Healthcare | KPS | |
| Z-2578-2018 | Class II | Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22 | GE Healthcare | KPS | |
| Z-0353-2019 | Class III | Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software... | Siemens Healthcare Diagnostics Inc. | JQP | |
| Z-2411-2018 | Class II | FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN... | Fort Defiance Industries, LLC | FLE | |
| Z-2254-2018 | Class II | Perseus A500 Anesthesia Machine; Cat. no. MK06000 Product V Product Usage: Intended for... | Draeger, Inc. | BSZ | |
| Z-2253-2018 | Class II | Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous... | Draeger, Inc. | BSZ | |
| Z-2252-2018 | Class II | Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalation anesthesia... | Draeger, Inc. | BSZ |