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-3278-2018 | Class II | Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The... | CooperSurgical, Inc. | GAD | |
| Z-0098-2019 | Class II | Colpo-Pneumo Occluder, Part CPO-6 | CooperSurgical, Inc. | HEW | |
| Z-0019-2019 | Class II | Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and... | Leica Microsystems, Inc. | KIM | |
| Z-3175-2018 | Class II | Leica M525 F20 Surgical Microscope System | Leica Microsystems, Inc. | EPT | |
| Z-0063-2019 | Class II | Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm Dual Reservoir... | Gentherm Medical, LLC | DWC | |
| Z-0227-2019 | Class II | VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product... | Terumo Cardiovascular Systems Corporation | GEI | |
| Z-0094-2019 | Class II | Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size... | WS Audiology A/S | ESD | |
| Z-0524-2019 | Class II | Solar 9500 Information Monitoring System is used to monitor physiologic parameter data... | GE Healthcare | MHX | |
| Z-0523-2019 | Class II | Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on... | GE Healthcare | MHX | |
| Z-0522-2019 | Class II | Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on... | GE Healthcare | MHX | |
| Z-0521-2019 | Class II | Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on... | GE Healthcare | MHX | |
| Z-0520-2019 | Class II | Dash 4000 Patient Monitoring System is used to monitor physiologic parameter data on... | GE Healthcare | MHX | |
| Z-0519-2019 | Class II | Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on... | GE Healthcare | MHZ | |
| Z-3211-2018 | Class II | Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to... | Accuray Incorporated | IYE | |
| Z-0195-2019 | Class II | Centricity Universal Viewer with Cross Enterprise Display This impacts product versions... | GE Healthcare | LLZ | |
| Z-0280-2019 | Class II | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model... | Medtronic Navigation, Inc | OXO | |
| Z-0279-2019 | Class II | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GER, Model... | Medtronic Navigation, Inc | OXO | |
| Z-0278-2019 | Class II | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model... | Medtronic Navigation, Inc | OXO | |
| Z-0277-2019 | Class II | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, Model Number... | Medtronic Navigation, Inc | OXO | |
| Z-0276-2019 | Class II | O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK... | Medtronic Navigation, Inc | OXO | |
| Z-0275-2019 | Class II | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number... | Medtronic Navigation, Inc | OXO | |
| Z-0274-2019 | Class II | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model... | Medtronic Navigation, Inc | OXO | |
| Z-0273-2019 | Class II | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, Model Number... | Medtronic Navigation, Inc | OXO | |
| Z-0272-2019 | Class II | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model... | Medtronic Navigation, Inc | OXO | |
| Z-0271-2019 | Class II | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number... | Medtronic Navigation, Inc | OXO | |
| Z-0494-2019 | Class II | KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA... | Becton Dickinson & Co | JTW | |
| Z-0493-2019 | Class II | KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection... | Becton Dickinson & Co | JTW | |
| Z-0492-2019 | Class II | BD Vacutainer Specimen Collection Cups, Cat. No. 364975 | Becton Dickinson & Co | JTW | |
| Z-0491-2019 | Class II | BD Vacutainer Urine Collection Cups, Cat. No. 364941 | Becton Dickinson & Co | JTW | |
| Z-0282-2019 | Class II | Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-0170-2019 | Class II | Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00 | Datascope Corp. | MHX | |
| Z-0208-2019 | Class II | Mitek Screw and Washer Depth Gauge, Product Code 219024 | DePuy Mitek, Inc. | LXH | |
| Z-0088-2019 | Class II | Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a)... | MEDLINE INDUSTRIES, LP - Northfield | NEC | |
| Z-1058-2019 | Class II | Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor... | Sanrai International LLC | CAF | |
| Z-0078-2019 | Class II | Insorb Subcuticular Skin Stapler, Ref 2030 | Incisive Surgical, Inc. | GDW | |
| Z-0203-2019 | Class II | IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that... | Data Innovations, LLC | JQP | |
| Z-1296-2019 | Class II | Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT... | Abbott Medical | CGZ | |
| Z-0291-2019 | Class II | Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product... | Stryker Corp. | KTT | |
| Z-0290-2019 | Class II | Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product... | Stryker Corp. | KTT | |
| Z-0289-2019 | Class II | Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product... | Stryker Corp. | KTT | |
| Z-0288-2019 | Class II | Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage... | Stryker Corp. | KTT | |
| Z-0392-2019 | Class II | VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number... | Ortho-Clinical Diagnostics, Inc. | CDD | |
| Z-0067-2019 | Class II | Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407... | HeartWare, Inc. | DSQ | |
| Z-3243-2018 | Class II | Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary... | Terumo Cardiovascular Systems Corporation | DTQ | |
| Z-3242-2018 | Class II | Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary... | Terumo Cardiovascular Systems Corporation | DTQ | |
| Z-0188-2019 | Class I | CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS... | Alcon Laboratories | OGO | |
| Z-0187-2019 | Class I | CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007... | Alcon Laboratories | OGO | |
| Z-0186-2019 | Class I | CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS... | Alcon Laboratories | OGO | |
| Z-0185-2019 | Class I | CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #... | Alcon Laboratories | OGO | |
| Z-2992-2018 | Class II | VidiStar(TM) PACS & DICOM Viewer Software system | Hitachi Healthcare Americas Corp Informatics Division | DQK |