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-1486-2018 | Class II | ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no... | Siemens Healthcare Diagnostics Inc. | LTK | |
| Z-1382-2018 | Class II | Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401... | Draeger Medical Systems, Inc. | MHX | |
| Z-1385-2018 | Class II | Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon... | Datascope Corp. | DSP | |
| Z-1384-2018 | Class II | Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon... | Datascope Corp. | DSP | |
| Z-1383-2018 | Class II | Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon... | Datascope Corp. | DSP | |
| Z-1262-2018 | Class II | F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory... | Allen Medical Systems, Inc. | N/A | |
| Z-2483-2018 | Class II | Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML... | Medtronic, Inc. | LRP | |
| Z-2482-2018 | Class II | Presource PBDS, Kit, No Spiro. Kit includes a exerciser volumetric 5000 ML device, two... | Medtronic, Inc. | LRP | |
| Z-2481-2018 | Class II | Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML device, two... | Medtronic, Inc. | LRP | |
| Z-2480-2018 | Class II | Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML... | Medtronic, Inc. | LRP | |
| Z-1700-2018 | Class II | Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System... | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-1699-2018 | Class II | Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a... | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-0976-2018 | Class II | IMRIS T2X Table, Part Number 109682-600 | IMRIS Imaging, Inc. | FQO | |
| Z-0975-2018 | Class II | IMRIS ORT100 Table, Part Number 110470-000 | IMRIS Imaging, Inc. | KXJ | |
| Z-0287-2019 | Class I | SpF PLUS-Mini (60 A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable... | Zimmer GmbH | LOE | |
| Z-0286-2019 | Class I | EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth... | Zimmer GmbH | LOE | |
| Z-1359-2018 | Class III | Strauss Penis Clamp 130MM/General Instruments | Aesculap Inc | FHA | |
| Z-1358-2018 | Class III | Doyen-Collin Mouth Gag 120MM/ General Instruments | Aesculap Inc | KBN | |
| Z-2218-2019 | Class II | The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy... | Ra Medical Systems,Inc | PDU | |
| Z-1776-2018 | Class II | Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The... | Transonic Systems Inc | PEH | |
| Z-1392-2018 | Class II | Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated... | Philips North America LLC | KPS | |
| Z-1459-2018 | Class II | SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of the body by... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1458-2018 | Class II | SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1457-2018 | Class II | SOMATOM Sensation Open Intended to produce cross-sections images of the body by computer... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1456-2018 | Class II | SOMATOM Sensation 64 Intended to produce cross-sections images of the body by computer... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1455-2018 | Class II | SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1454-2018 | Class II | SOMATOM Sensation 16 Intended to produce cross-sections images of the body by computer... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1453-2018 | Class II | SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1452-2018 | Class II | SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1451-2018 | Class II | SOMATOM Spirit Intended to produce cross-sections images of the body by computer... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1450-2018 | Class II | SOMATOM Scope Power Intended to produce cross-sections images of the body by computer... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1449-2018 | Class II | SOMATOM Scope Intended to produce cross-sections images of the body by computer... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1448-2018 | Class II | SOMATOM Perspective 16 Intended to produce cross-sections images of the body by computer... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1447-2018 | Class II | SOMATOM Perspective Intended to produce cross-sections images of the body by computer... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1446-2018 | Class II | SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1445-2018 | Class II | SOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1193-2018 | Class II | Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations. | Teleflex Medical | GDT | |
| Z-1402-2018 | Class II | PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1401-2018 | Class II | ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Product Usage: The... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1400-2018 | Class II | ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product Usage: The... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1399-2018 | Class II | ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1398-2018 | Class II | ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product Usage: The... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1397-2018 | Class II | MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1006-2018 | Class II | ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately... | Brainlab, Inc. | IYE | |
| Z-1632-2018 | Class III | Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The... | Michigan Instruments | DRM | |
| Z-2056-2018 | Class II | BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No... | Becton Dickinson & Co | JKA | |
| Z-2055-2018 | Class II | BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No... | Becton Dickinson & Co | JKA | |
| Z-1798-2018 | Class II | FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation... | Inpeco S.p.A. | JQP | |
| Z-1070-2018 | Class II | RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100... | Stanbio Laboratory | DHR | |
| Z-0643-2018 | Class II | Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled... | PENTAX of America, Inc. | FDT |