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-1908-2019 | Class II | REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers... | Baxter Healthcare Corporation | KDI | |
| Z-1926-2019 | Class II | CLEO Patient Monitor /Tranquility VS Patient Monitor | Infinium Medical, Inc | MWI | |
| Z-1904-2020 | Class II | Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V. | Ortho Development Corp. | JWH | |
| Z-1903-2020 | Class II | Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V. | Ortho Development Corp. | JWH | |
| Z-2118-2020 | Class II | Clearview Total Uterine Manipulator (model UM750), The device is labeled in part... | Clinical Innovations, LLC | LKF | |
| Z-1698-2020 | Class II | Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for... | Boston Scientific Neuromodulation Corporation | GXI | |
| Z-1697-2020 | Class II | Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is... | Boston Scientific Neuromodulation Corporation | GXI | |
| Z-1696-2020 | Class II | Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indicated for... | Boston Scientific Neuromodulation Corporation | GXI | |
| Z-1695-2020 | Class II | Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is... | Boston Scientific Neuromodulation Corporation | GXI | |
| Z-1694-2020 | Class II | Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for... | Boston Scientific Neuromodulation Corporation | GXI | |
| Z-0022-2020 | Class I | Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor... | Galemed Corp. | BZD | |
| Z-0021-2020 | Class I | Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only... | Galemed Corp. | BZD | |
| Z-0020-2020 | Class I | Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562 | Galemed Corp. | BZD | |
| Z-0019-2020 | Class II | Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P | Paltop Advanced Dental Solutions Ltd | DZE | |
| Z-2279-2019 | Class II | BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number... | Becton Dickinson & Co | N/A | |
| Z-1984-2019 | Class II | Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit... | MEDLINE INDUSTRIES, LP - Northfield | OCT | |
| Z-2278-2019 | Class II | SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM)... | Orthopediatrics Canada ULC | HSB | |
| Z-2238-2019 | Class I | Quantum Pump Console | Spectrum Medical Inc | DTQ | |
| Z-2151-2019 | Class II | Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform... | Fresenius Medical Care Renal Therapies Group, LLC | FKX | |
| Z-2059-2019 | Class II | Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with... | Zyno Medical LLC. | FPA | |
| Z-2058-2019 | Class II | Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with... | Zyno Medical LLC. | FPA | |
| Z-1887-2019 | Class II | EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage... | AtriCure, Inc. | OCL | |
| Z-2135-2019 | Class II | Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test... | Siemens Healthcare Diagnostics Inc. | MMI | |
| Z-2250-2020 | Class II | Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462... | Nobel Biocare USA LLC | DZE | |
| Z-2044-2020 | Class II | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline... | MEDLINE INDUSTRIES, LP - Northfield | EZL | |
| Z-2043-2020 | Class II | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline... | MEDLINE INDUSTRIES, LP - Northfield | EZL | |
| Z-2042-2020 | Class II | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline... | MEDLINE INDUSTRIES, LP - Northfield | EZL | |
| Z-0170-2020 | Class II | The ICS CHARTR EP 200 | Natus Medical Denmark ApS | GWJ | |
| Z-1918-2019 | Class II | SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1917-2019 | Class II | SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20A_SP0... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1916-2019 | Class II | SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1915-2019 | Class II | SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1948-2019 | Class II | K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable... | Zimmer GmbH | LXH | |
| Z-1947-2019 | Class II | DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express... | Zimmer GmbH | HTJ | |
| Z-1945-2019 | Class II | ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and... | ZOLL Medical Corporation | DTE | |
| Z-1946-2019 | Class II | DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express... | Zimmer GmbH | HXX | |
| Z-1966-2019 | Class II | Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number... | Datascope Corp. | DSP | |
| Z-2055-2019 | Class II | Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer... | InfuTronix LLC | FRN | |
| Z-1864-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF | Maquet Cardiovascular Us Sales, LLC | FTD | |
| Z-1863-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF | Maquet Cardiovascular Us Sales, LLC | FTD | |
| Z-1862-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF | Maquet Cardiovascular Us Sales, LLC | FTD | |
| Z-1861-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF | Maquet Cardiovascular Us Sales, LLC | FTD | |
| Z-1860-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM | Maquet Cardiovascular Us Sales, LLC | FTD | |
| Z-1859-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM | Maquet Cardiovascular Us Sales, LLC | FTD | |
| Z-1858-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM | Maquet Cardiovascular Us Sales, LLC | FTD | |
| Z-1857-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM | Maquet Cardiovascular Us Sales, LLC | FTD | |
| Z-1856-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP | Maquet Cardiovascular Us Sales, LLC | FTD | |
| Z-1855-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP | Maquet Cardiovascular Us Sales, LLC | FTD | |
| Z-1854-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP | Maquet Cardiovascular Us Sales, LLC | FTD | |
| Z-1853-2019 | Class II | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP | Maquet Cardiovascular Us Sales, LLC | FTD |