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-0806-2016 | Class II | MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc. | Viewray Systems, Inc. | IYE | |
| Z-0750-2016 | Class II | BacT/ALERT FA, bioMrieux, Inc., Product Usage: BacT/ALERT Culture Bottles are used with... | bioMerieux, Inc. | MDB | |
| Z-0749-2016 | Class II | BacT/ALERT SN, bioMrieux, Inc. Product Usage: BacT/ALERT Culture Bottles are used with... | bioMerieux, Inc. | MDB | |
| Z-2217-2017 | Class II | Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Cap 1000 | Cardinal Scale Mfg Co | FRI | |
| Z-1864-2016 | Class II | Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage | FUJIFILM Healthcare Americas Corporation | FDT | |
| Z-1863-2016 | Class II | Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage | FUJIFILM Healthcare Americas Corporation | FDT | |
| Z-1862-2016 | Class II | Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage | FUJIFILM Healthcare Americas Corporation | FDT | |
| Z-1861-2016 | Class II | Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection | FUJIFILM Healthcare Americas Corporation | FDT | |
| Z-1860-2016 | Class II | Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning... | FUJIFILM Healthcare Americas Corporation | FDT | |
| Z-1016-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00549600 (XMD P/N 70-0050-G24) The... | Xeridiem Medical Devices | PIF | |
| Z-1015-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00549460 (XMD P/N 70-0050-G22) The... | Xeridiem Medical Devices | PIF | |
| Z-1014-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548970 (XMD P/N 70-0050-G20) The... | Xeridiem Medical Devices | PIF | |
| Z-1013-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548810 (XMD P/N 70-0050-G18) The... | Xeridiem Medical Devices | PIF | |
| Z-1012-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548650 (XMD P/N 70-0050-G16) The... | Xeridiem Medical Devices | PIF | |
| Z-1011-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548490 (XMD P/N 70-0050-G14) The... | Xeridiem Medical Devices | PIF | |
| Z-1010-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00549590 (XMD P/N 70-0050-F24) The... | Xeridiem Medical Devices | PIF | |
| Z-1009-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00549450 (XMD P/N 70-0050-F22) The... | Xeridiem Medical Devices | PIF | |
| Z-1008-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548960 (XMD P/N 70-0050-F20) The... | Xeridiem Medical Devices | PIF | |
| Z-0770-2016 | Class II | GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System Designed to... | GE Healthcare | IZL | |
| Z-1007-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548800 (XMD P/N 70-0050-F18) The... | Xeridiem Medical Devices | PIF | |
| Z-0769-2016 | Class II | GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to... | GE Healthcare | IZL | |
| Z-1006-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548640 (XMD P/N 70-0050-F16) The... | Xeridiem Medical Devices | PIF | |
| Z-1005-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548480 (XMD P/N 70-0050-F14) The... | Xeridiem Medical Devices | PIF | |
| Z-1004-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00549580 (XMD P/N 70-0050-E24) The... | Xeridiem Medical Devices | PIF | |
| Z-1003-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00549440 (XMD P/N 70-0050-E22) The... | Xeridiem Medical Devices | PIF | |
| Z-1002-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548950 (XMD P/N 70-0050-E20) The... | Xeridiem Medical Devices | PIF | |
| Z-1001-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548790 (XMD P/N 70-0050-E18) The... | Xeridiem Medical Devices | PIF | |
| Z-1000-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548630 (XMD P/N 70-0050-E16) The... | Xeridiem Medical Devices | PIF | |
| Z-0999-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548470 (XMD P/N 70-0050-E14) The... | Xeridiem Medical Devices | PIF | |
| Z-0998-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00549570 (XMD P/N 70-0050-D24) The... | Xeridiem Medical Devices | PIF | |
| Z-0997-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00549430 (XMD P/N 70-0050-D22) The... | Xeridiem Medical Devices | PIF | |
| Z-0996-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548780 (XMD P/N 70-0050-D20) The... | Xeridiem Medical Devices | PIF | |
| Z-0995-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548620 (XMD P/N 70-0050-D16) The... | Xeridiem Medical Devices | PIF | |
| Z-0994-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-0050-D14) The... | Xeridiem Medical Devices | PIF | |
| Z-0993-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00549560 (XMD P/N 70-0050-C24) The... | Xeridiem Medical Devices | PIF | |
| Z-0992-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00549420 (XMD P/N 70-0050-C22) The... | Xeridiem Medical Devices | PIF | |
| Z-0991-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548930 (XMD P/N 70-0050-C20) The... | Xeridiem Medical Devices | PIF | |
| Z-0990-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548770 (XMD P/N 70-0050-C18) The... | Xeridiem Medical Devices | PIF | |
| Z-0989-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548610 (XMD P/N 70-0050-C16) The... | Xeridiem Medical Devices | PIF | |
| Z-0988-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548450 (XMD P/N 70-0050-C14) The... | Xeridiem Medical Devices | PIF | |
| Z-0987-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00549550 (XMD P/N 70-0050-B24) The... | Xeridiem Medical Devices | PIF | |
| Z-0986-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00549410 (XMD P/N 70-0050-B22) The... | Xeridiem Medical Devices | PIF | |
| Z-0985-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548920 (XMD P/N 70-0050-B20) The... | Xeridiem Medical Devices | PIF | |
| Z-0984-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548760 (XMD P/N 70-0050-B18) The... | Xeridiem Medical Devices | PIF | |
| Z-0983-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548600 (XMD P/N 70-0050-B16) The... | Xeridiem Medical Devices | PIF | |
| Z-0982-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548440 (XMD P/N 70-0050-B14) The... | Xeridiem Medical Devices | PIF | |
| Z-0981-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548320 (XMD P/N 70-0050-B12) The... | Xeridiem Medical Devices | PIF | |
| Z-0980-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00549540 (XMD P/N 70-0050-A24) The... | Xeridiem Medical Devices | PIF | |
| Z-0979-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00549400 (XMD P/N 70-0050-A22) The... | Xeridiem Medical Devices | PIF | |
| Z-0978-2016 | Class II | EndoVive 3s Low Profile Balloon Kits Part Number: M00548910 (XMD P/N 70-0050-A20) The... | Xeridiem Medical Devices | PIF |