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-1942-2017 | Class II | IMRI AIR CONTROL Product Usage: Pneumatic system | The Anspach Effort, Inc. | HBE | |
| Z-1941-2017 | Class II | BLACKMAX-NEURO LOW PRESSURE Product Usage: Pneumatic system | The Anspach Effort, Inc. | HSZ | |
| Z-1940-2017 | Class II | 19cm Attachment, Black Max Product Usage: Pneumatic system | The Anspach Effort, Inc. | GFF | |
| Z-1939-2017 | Class II | Autolube-III with NK Product Usage: Pneumatic system | The Anspach Effort, Inc. | GET | |
| Z-1938-2017 | Class II | Autolube-III with Irrigation Product Usage: Pneumatic system | The Anspach Effort, Inc. | GEY | |
| Z-1937-2017 | Class II | Autolube-III with Foot Guard Product Usage: Pneumatic system | The Anspach Effort, Inc. | GEY | |
| Z-1936-2017 | Class II | AL-III-DISS Adapter Product Usage: Pneumatic system | The Anspach Effort, Inc. | GEY | |
| Z-1935-2017 | Class II | Autolube-III with 20ft hose Product Usage: Pneumatic system | The Anspach Effort, Inc. | GEY | |
| Z-1934-2017 | Class II | Autolube-III Product Usage: Pneumatic system | The Anspach Effort, Inc. | GEY | |
| Z-1933-2017 | Class II | Foot control irrigation system Product Usage: Pneumatic system | The Anspach Effort, Inc. | GEY | |
| Z-1932-2017 | Class II | AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic system | The Anspach Effort, Inc. | GEY | |
| Z-1931-2017 | Class II | AL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic system | The Anspach Effort, Inc. | GEY | |
| Z-1930-2017 | Class II | 14cm QD Angle Attachment Product Usage: Product attachment | The Anspach Effort, Inc. | HBC | |
| Z-1098-2017 | Class II | Softbank software Product Usage: Decision support software for transfusion service. It... | SCC Soft Computer | NSX | |
| Z-1097-2017 | Class II | SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site... | SCC Soft Computer | NSX | |
| Z-0380-2017 | Class II | Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology... | Stryker Sustainability Solutions | NLH | |
| Z-0297-2017 | Class II | The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle... | Cordis US Corp. | MJN | |
| Z-0819-2017 | Class II | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55 S61CM D66CM GLOBALCatalog #... | Oscor Inc. | DYB | |
| Z-0818-2017 | Class II | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90 S61CM D66CM GLOBAL Catalog #... | Oscor Inc. | DYB | |
| Z-0817-2017 | Class II | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90 S79CM D84CM GLOBAL Catalog #... | Oscor Inc. | DYB | |
| Z-0816-2017 | Class II | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70 S79CM D84CM GLOBAL Catalog #... | Oscor Inc. | DYB | |
| Z-0815-2017 | Class II | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55 S79CM D84CM GLOBAL Catalog #... | Oscor Inc. | DYB | |
| Z-0814-2017 | Class II | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120 S61CM D66CM GLOBAL Catalog #... | Oscor Inc. | DYB | |
| Z-0813-2017 | Class II | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90 S61CM D66CM GLOBAL Catalog #... | Oscor Inc. | DYB | |
| Z-0812-2017 | Class II | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70 S61CM D66CM GLOBAL Catalog #... | Oscor Inc. | DYB | |
| Z-0811-2017 | Class II | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55 S61CM D66CM GLOBAL Catalog #... | Oscor Inc. | DYB | |
| Z-0810-2017 | Class II | OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate... | Oscor Inc. | DYB | |
| Z-0809-2017 | Class II | OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is designed to... | Oscor Inc. | DYB | |
| Z-0808-2017 | Class II | OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to... | Oscor Inc. | DYB | |
| Z-0807-2017 | Class II | OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to... | Oscor Inc. | DYB | |
| Z-0806-2017 | Class II | OSCOR ADELANTE BREEZEWAY 10F C120 S79CM D84CM Catalog # AB101078 Is designed to... | Oscor Inc. | DYB | |
| Z-0805-2017 | Class II | OSCOR ADELANTE BREEZEWAY 10F C90 S79CM D84CM Catalog # AB101078 Is designed to... | Oscor Inc. | DYB | |
| Z-0804-2017 | Class II | OSCOR ADELANTE BREEZEWAY 10F C70 S79CM D84CM Catalog # AB101077 Is designed to... | Oscor Inc. | DYB | |
| Z-0803-2017 | Class II | OSCOR ADELANTE BREEZEWAY 10F C55 S79CM D84CM Catalog # AB101076 Is designed to... | Oscor Inc. | DYB | |
| Z-0802-2017 | Class II | OSCOR ADELANTE BREEZEWAY 10F C120 S61CM D66CM Catalog # AB101075 Is designed to... | Oscor Inc. | DYB | |
| Z-0801-2017 | Class II | OSCOR ADELANTE BREEZEWAY 10F C70 S61CM D66CM Catalog # AB101073 Is designed to... | Oscor Inc. | DYB | |
| Z-0800-2017 | Class II | OSCOR ADELANTE BREEZEWAY 10F C55 S61CM D66CM Catalog # AB101072 Is designed to facilitate... | Oscor Inc. | DYB | |
| Z-0799-2017 | Class II | OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to... | Oscor Inc. | DYB | |
| Z-0798-2017 | Class II | OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is designed to... | Oscor Inc. | DYB | |
| Z-0797-2017 | Class II | OSCOR ADELANTE BREEZEWAY 8F C120 S79CM D84CM Catalog # AB081047 Is designed to... | Oscor Inc. | DYB | |
| Z-0796-2017 | Class II | OSCOR ADELANTE BREEZEWAY 8F C90 S79CM D84CM Catalog # AB081046 Is designed to facilitate... | Oscor Inc. | DYB | |
| Z-0795-2017 | Class II | OSCOR ADELANTE BREEZEWAY 8F C70 S79CM D84CM Catalog # AB081045 Is designed to facilitate... | Oscor Inc. | DYB | |
| Z-0794-2017 | Class II | OSCOR ADELANTE BREEZEWAY 8F C55 S79CM D84CM Catalog # AB081044 Is designed to facilitate... | Oscor Inc. | DYB | |
| Z-0793-2017 | Class II | OSCOR ADELANTE BREEZEWAY 8F C120 S61CM D66CM Catalog # AB081043 Is designed to... | Oscor Inc. | DYB | |
| Z-0792-2017 | Class II | OSCOR ADELANTE BREEZEWAY 8F C90 S61CM D66CM Catalog # AB081042 Is designed to facilitate... | Oscor Inc. | DYB | |
| Z-0791-2017 | Class II | OSCOR ADELANTE BREEZEWAY 8F C70 S61CM D66CM Catalog # AB081041 Is designed to facilitate... | Oscor Inc. | DYB | |
| Z-0790-2017 | Class II | OSCOR ADELANTE BREEZEWAY 8F C55 S61CM D66CM Catalog # AB081040 Is designed to facilitate... | Oscor Inc. | DYB | |
| Z-0903-2017 | Class II | VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product... | Ortho-Clinical Diagnostics, Inc. | CEW | |
| Z-0315-2017 | Class II | da Vinci Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and... | Intuitive Surgical, Inc. | NAY | |
| Z-0347-2017 | Class II | Guider Softip XF; GUIDER 40XF 5F 90CM, Model number:M003100620 . Cardiology: Boston... | Stryker Corp. | DQY |