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-1892-2010 | Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS. | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-1591-2010 | VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator... | LivaNova USA, Inc. | LYJ | ||
| Z-2217-2010 | Trabecular Metal acetabular revision system column buttress right posterior/left... | Zimmer GmbH | LPH | ||
| Z-2216-2010 | Trabecular Metal acetabular revision system column buttress left posterior/right... | Zimmer GmbH | LPH | ||
| Z-2215-2010 | Trabecular Metal acetabular revision system buttress augment size, 58, 00-4898-001-58... | Zimmer GmbH | LPH | ||
| Z-2214-2010 | Trabecular Metal acetabular revision system buttress augment size, 54, 00-4898-001-54... | Zimmer GmbH | LPH | ||
| Z-1597-2010 | BD Visitec EdgeAhead MVR Knife, BD Opthalmic Systems, Waltham, MA. Intended for use in... | Becton Dickinson & Co | HNN | ||
| Z-2421-2010 | CELL-DYN Sapphire Probe Detector PCB Assembly (also called the Aspiration Bottom Sensor)... | Abbott Medical | GKZ | ||
| Z-1898-2010 | Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System... | Cepheid | NQX | ||
| Z-2120-2010 | Howmedica Osteonics Corp., Stryker Orthopaedics Passport A.R. Knee Instrumentation... | Howmedica Osteonics Corp | LXH | ||
| Z-2119-2010 | X-Celerate Instrumentation Punch Thru Tibial Base Plate, Catalog numbers: 3750-0003... | Howmedica Osteonics Corp | LXH | ||
| Z-2118-2010 | Howmedica Osteonics Corp, Stryker Orthopaedics Passport A.R. Knee Instrumentation Distal... | Howmedica Osteonics Corp | LXH | ||
| Z-1546-2010 | AEM Disposable Electrode, L-Wedge, 45cm, REF ES0312-45, Qty 10 each Sterile R... | Encision, Inc. | GEI | ||
| Z-1545-2010 | AEM Disposable Electrode, L-Wedge, 35cm, REF ES0312, Qty 10 each Sterile R, Manufactured... | Encision, Inc. | GEI | ||
| Z-1544-2010 | AEM Disposable Electrode, L-Diamond, 35cm, REF ES0311, Qty 10 each Sterile R... | Encision, Inc. | GEI | ||
| Z-1543-2010 | AEM Disposable Electrode, J-Hook, 45cm, REF ES0310-45, Sterile R, Manufactured for... | Encision, Inc. | GEI | ||
| Z-1542-2010 | AEM Disposable Electrode, J-Hook, 35cm, REF ES0310, Qty 10 each Sterile R, Manufactured... | Encision, Inc. | GEI | ||
| Z-1541-2010 | AEM Disposable Electrode, Flat J-Hook, 35cm, REF ES0309, Qty 10 each Sterile R... | Encision, Inc. | GEI | ||
| Z-1540-2010 | AEM Disposable Electrode, Spatula, 45cm, REF ES0301-45, Qty 10 each Sterile R... | Encision, Inc. | GEI | ||
| Z-1539-2010 | AEM Disposable Electrode, Spatula, 35cm, REF ES0301, Qty: 10 each Sterile R, Manufactured... | Encision, Inc. | GEI | ||
| Z-1003-2013 | Class II | Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body... | Philips North America LLC | JAK | |
| Z-2030-2010 | Medtronic U-CLIP Double Arm Approximation Device, model V100D U-Clip, Catalog Number... | Medtronic Perfusion Systems | FZP | ||
| Z-1804-2010 | Synthes Medullary Tubes | Synthes GmbH | LXH | ||
| Z-1610-2010 | Disposable Skin Stapler - 35 Wide; Surgical Skin Stapler; Rx, sterile, single use skin... | Medtronic, Inc. | GAG | ||
| Z-0166-2011 | Siemens brand 550 TxT Patient Table, Part No. 7346534, Distributed by and/or Manufactured... | Siemens Medical Solutions USA, Inc. | JAI | ||
| Z-1953-2010 | Toggleloc Artificial ligament fixation device ZIPLOOP Technology Implant Kit, Sterile... | Zimmer GmbH | MBI | ||
| Z-1952-2010 | Artificial ligament fixation device # 7PE ZIPLOOP Extended Toggle, Sterile, REF 904755... | Zimmer GmbH | MBI | ||
| Z-2023-2011 | Siemens brand 550 TxT Patient Treatment Table, part number 7346534; Product is... | Siemens Medical Solutions USA, Inc. | JAI | ||
| Z-0143-2012 | Bioplate Titanium Fixation System, Sterile Kit. The sterile plate and screw kit... | Bioplate Inc | JEY | ||
| Z-1973-2010 | TORQ Sternal Closure Device, SINGLE-USE Intended use: The device is a sterile... | KARDIUM Inc. | HXS | ||
| Z-1598-2010 | ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF... | Medtronic, Inc. | FGE | ||
| Z-0308-2012 | ViroMax viral/bacterial filter. The filter reduces the risk of infection due to... | A-M Systems | CAH | ||
| Z-1594-2010 | Stryker Orthopaedics, Accolade Distal Centralizer 13 mm Medium; Catalog No.: 1059-4513... | Howmedica Osteonics Corp | JDI | ||
| Z-1593-2010 | Stryker Orthopaedics, Accolade Distal Centralizer 14 mm Large; Catalog No.: 1059-6714... | Howmedica Osteonics Corp | JDI | ||
| Z-0893-2011 | Hemochron Signature Elite Whole Blood Microcoagulation (IVD) System. The system is... | Accriva Diagnostics, Inc. | RFZ | ||
| Z-0924-2011 | Mizuho ProFx 6850 Operating Room Table, with orthopedic accessories, AC Powered... | Mizuho Orthopedic Systems Inc | JEA | ||
| Z-0314-2011 | Depth Stop Adapter 66-AC-DS(1.8), E6-01-.5 used with the microTargeting and STar... | FHC, Inc. | HAW | ||
| Z-0313-2011 | microTargeting Drive DBS Lead Holder 66-CN-DB Product is the FHC DBS Depth Stop Adapter... | FHC, Inc. | HAW | ||
| Z-0312-2011 | STar Drive System, Catalog numbers: ST-DS-MA, ST-DS-ME, 70-ZD-ME Product is the FHC DBS... | FHC, Inc. | HAW | ||
| Z-0311-2011 | microTargeting Drive System with Mounted Accessories Catalog numbers : 66-ZD-MD-01... | FHC, Inc. | HAW | ||
| Z-0342-2011 | The box label states: "ATF 120 Fast Start Kit 9108501...STERILE...FRESENIUS... | Fresenius Kabi AB | CAC | ||
| Z-0341-2011 | The box label states: "ATF 40 Fast Start Kit 9108491...STERILE...FRESENIUS... | Fresenius Kabi AB | CAC | ||
| Z-0340-2011 | The box label states: "AT1 Autotransfusion Set 9005101 STERILE...FRESENIUS... | Fresenius Kabi AB | CAC | ||
| Z-1633-2010 | Leica Wireless Footswitch, Type B used in conjunction with Leica Surgical Microscopes... | Leica Microsystems, Inc. | FSO | ||
| Z-1682-2010 | Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | ||
| Z-1573-2010 | ClearVac Goldline Rocker Switch with UltraClean Blade Electrode, REF 60-6829-005A... | ConMed Corporation | GEI | ||
| Z-1572-2010 | ClearVac Goldline Rocker Switch with Blade Electrode, REF 60-6829-001A, Sterile R... | ConMed Corporation | GEI | ||
| Z-1571-2010 | ConMed Goldline Hand Controlled with UltraClean Blade Electrode, Rocker Switch, Safety... | ConMed Corporation | GEI | ||
| Z-1570-2010 | ConMed Goldline Hand Controlled with UltraClean Blade Electrode, Rocker Switch, Safety... | ConMed Corporation | GEI | ||
| Z-1569-2010 | ConMed Goldline Hand Controlled with UltraClean Blade Electrode, Rocker Switch, Safety... | ConMed Corporation | GEI |