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-1589-2020 | Class II | Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K | Medtronic, Inc. | OYC | |
| Z-1588-2020 | Class II | Medtronic MiniMed Paradigm Insulin pump, model number MMT-722 | Medtronic, Inc. | OYC | |
| Z-1587-2020 | Class II | Medtronic MiniMed Paradigm Insulin pump, model number MMT-522 | Medtronic, Inc. | OYC | |
| Z-0011-2020 | Class II | Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL... | Inter-Med, Inc. | KJJ | |
| Z-1586-2020 | Class II | Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715 | Medtronic, Inc. | LZG | |
| Z-1585-2020 | Class II | Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E | Medtronic, Inc. | LZG | |
| Z-1584-2020 | Class II | MiniMed Paradigm Insulin pump, model number MMT-712 | Medtronic, Inc. | LZG | |
| Z-1583-2020 | Class II | MiniMed Paradigm 512 Insulin pump | Medtronic, Inc. | LZG | |
| Z-1582-2020 | Class II | MiniMed Paradigm Model 511 Insulin Pump | Medtronic, Inc. | LZG | |
| Z-1581-2020 | Class II | MiniMed Insulin Pump, model # MMT-508 | Medtronic, Inc. | LZG | |
| Z-2056-2019 | Class II | AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The... | Agfa N.V. | JAA | |
| Z-2444-2019 | Class II | AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE... | Boston Scientific Corporation | GEX | |
| Z-2341-2019 | Class II | N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination... | Siemens Healthcare Diagnostics Inc. | JZW | |
| Z-2432-2019 | Class III | EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK... | Baxter Healthcare Corporation | KYX | |
| Z-2222-2019 | Class II | SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers... | MicroAire Surgical Instruments, LLC | HRX | |
| Z-0163-2020 | Class II | IMRIS MR/X-ray head fixation device, Model HFD200 | IMRIS Imaging, Inc. | HBL | |
| Z-0528-2022 | Class II | MAGEC 1 System | NuVasive Specialized Orthopedics, Inc. | PGN | |
| Z-2259-2019 | Class II | K-Wire HBS Sterile Lot, Item Number 19688 - Product Usage: Accessories to the BioPro... | Biopro, Inc. | NBH | |
| Z-2258-2019 | Class II | Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the BioPro Go-Ez... | Biopro, Inc. | NBH | |
| Z-2257-2019 | Class II | Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the BioPro Go-Ez... | Biopro, Inc. | NBH | |
| Z-2256-2019 | Class II | Go-EZ Screw 6.5x110, Item Number 19670 - Product Usage:Accessories to the BioPro Go-Ez... | Biopro, Inc. | NBH | |
| Z-2255-2019 | Class II | Go-EZ Screw 6.5x105, Item Number 19669 - Product Usage: Accessories to the BioPro Go-Ez... | Biopro, Inc. | NBH | |
| Z-2254-2019 | Class II | Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the BioPro Go-Ez... | Biopro, Inc. | NBH | |
| Z-2253-2019 | Class II | Go-EZ Screw 6.5x115, Item Number 19671 - Product Usage: Accessories to the BioPro Go-Ez... | Biopro, Inc. | NBH | |
| Z-2252-2019 | Class II | Go-EZ Screw 6.5x90, Item Number 19666 - Product Usage:Accessories to the BioPro Go-Ez... | Biopro, Inc. | NBH | |
| Z-2251-2019 | Class II | Go-EZ Screw 6.5x85, Item Number 19665 - Product Usage: Accessories to the BioPro Go-Ez... | Biopro, Inc. | NBH | |
| Z-2250-2019 | Class II | Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the BioPro Go-Ez... | Biopro, Inc. | NBH | |
| Z-2249-2019 | Class II | Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the BioPro Go-Ez... | Biopro, Inc. | NBH | |
| Z-2248-2019 | Class II | Go-EZ Screw 6.5x36, Item Number 19654 - Product Usage: Accessories to the BioPro Go-Ez... | Biopro, Inc. | NBH | |
| Z-2247-2019 | Class II | Go-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the BioPro Go-Ez... | Biopro, Inc. | NBH | |
| Z-2246-2019 | Class II | Go-EZ Screw 6.5x30, Item Number 19651 - Product Usage: Accessories to the BioPro Go-Ez... | Biopro, Inc. | NBH | |
| Z-2245-2019 | Class II | K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the... | Biopro, Inc. | NBH | |
| Z-2244-2019 | Class II | K-Wire Single Trocar 1.1x150mm, Item Number OL15011S - Product Usage: Accessories to the... | Biopro, Inc. | NBH | |
| Z-2243-2019 | Class II | K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - Product Usage: Accessories to the... | Biopro, Inc. | NBH | |
| Z-2242-2019 | Class II | K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - Product Usage: Accessories to the... | Biopro, Inc. | NBH | |
| Z-2241-2019 | Class II | K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Accessories to the... | Biopro, Inc. | NBH | |
| Z-2240-2019 | Class II | K-Wire Sterile Single Trochar, Item Number 19106 - Product Usage: Accessories to the... | Biopro, Inc. | NBH | |
| Z-2239-2019 | Class II | K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez... | Biopro, Inc. | NBH | |
| Z-0318-2021 | Class II | 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only | OriGen Biomedical, Inc. | KFM | |
| Z-2194-2019 | Class II | Vereos PET/CT Model # 882446, computed tomography x-ray system | Philips North America LLC | JAK | |
| Z-2193-2019 | Class II | Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system | Philips North America LLC | JAK | |
| Z-2192-2019 | Class II | IQon Spectral CT Model # 728332, computed tomography x-ray system | Philips North America LLC | JAK | |
| Z-2191-2019 | Class II | Brilliance 64 Model # 728231, computed tomography x-ray system | Philips North America LLC | JAK | |
| Z-2190-2019 | Class II | iCT SP Model # 728311, computed tomography x-ray system | Philips North America LLC | JAK | |
| Z-2189-2019 | Class II | iCT, Model # 728306, computed tomography x-ray system | Philips North America LLC | JAK | |
| Z-2188-2019 | Class II | Ingenuity Core Model # 728321, computed tomography x-ray system | Philips North America LLC | JAK | |
| Z-2187-2019 | Class II | Ingenuity Core128 Model # 728323, computed tomography x-ray system | Philips North America LLC | JAK | |
| Z-2186-2019 | Class II | Ingenuity CT, Model # 728326, computed tomography x-ray system | Philips North America LLC | JAK | |
| Z-0409-2020 | Class II | NOSEBLEED TRAY Kit Code: MNS3885 | Centurion Medical Products, LP | OGR | |
| Z-0408-2020 | Class II | YNHH SCOPE KIT Kit Code: MNS10475 | Centurion Medical Products, LP | OGR |