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-1652-2009 | Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version: 2.11 or less. | FUJIFILM Healthcare Americas Corporation | JAK | ||
| Z-1651-2009 | Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less. | FUJIFILM Healthcare Americas Corporation | JAK | ||
| Z-1524-2009 | Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog... | Ascension Orthopedics, Inc. | HXX | ||
| Z-1415-2009 | 8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF... | Merit Medical Systems, Inc. | DYB | ||
| Z-1414-2009 | 8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM, REF... | Merit Medical Systems, Inc. | DYB | ||
| Z-1413-2009 | 8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 7CM Advance... | Merit Medical Systems, Inc. | DYB | ||
| Z-1412-2009 | 7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF... | Merit Medical Systems, Inc. | DYB | ||
| Z-1647-2009 | 7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM Guide... | Merit Medical Systems, Inc. | DYB | ||
| Z-1410-2009 | 7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 4CM Advance... | Merit Medical Systems, Inc. | DYB | ||
| Z-1409-2009 | 6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF... | Merit Medical Systems, Inc. | DYB | ||
| Z-1408-2009 | 6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM Guide... | Merit Medical Systems, Inc. | DYB | ||
| Z-1407-2009 | 6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 4CM Advance... | Merit Medical Systems, Inc. | DYB | ||
| Z-1406-2009 | 5F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF... | Merit Medical Systems, Inc. | DYB | ||
| Z-1405-2009 | 5F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM Guide... | Merit Medical Systems, Inc. | DYB | ||
| Z-1404-2009 | 5F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 4CM Advance... | Merit Medical Systems, Inc. | DYB | ||
| Z-1403-2009 | Prelude Short Sheath Introducer, McAlester Regional Hospital - Fistulagram Pack... | Merit Medical Systems, Inc. | DYB | ||
| Z-1402-2009 | Prelude Short Sheath Introducer, Carolina Kidney and Endocrine - Declot tray, K12T-02693... | Merit Medical Systems, Inc. | DYB | ||
| Z-2268-2010 | Hill-Rom 1000 bed model P1160. | Hill-Rom Inc. | FNL | ||
| Z-2267-2010 | Hill-Rom Care Assist Bed, Model P1170. | Hill-Rom Inc. | FNL | ||
| Z-1639-2009 | Surgidyne S-Vac round fluted channel silicone drain kit, 10 FR, round, full fluted, 4... | Aspen Surgical Products, Inc. | GCY | ||
| Z-1638-2009 | Surgidyne S-Vac round fluted channel silicone drain, 1/8" trocar, 10 FR, round, full... | Aspen Surgical Products, Inc. | GCY | ||
| Z-2243-2012 | Class III | Sunquest Encompass The reporting site is using the Encompass software in an acute... | CliniSys, Inc | JQP | |
| Z-1401-2009 | Panorama Patient Monitoring Network with ambulatory telepacks, and software version... | Datascope Corp. | MHX | ||
| Z-1390-2009 | HeartStart MRx Defibrillator/Monitor, M3535A/M3536A Is used for the termination of... | Philips North America LLC | MKJ | ||
| Z-1208-2010 | VNVD Veronikis Neo Vaginal Dilator - Complete Set Catalog No. 270-100, VNVD Veronikis... | Marina Medical Instruments Inc. | HDQ | ||
| Z-1207-2010 | VVD Veronikis Vaginal Dilator - Complete Set Catalog No. 270-000. Set Includes: VVD... | Marina Medical Instruments Inc. | HDQ | ||
| Z-1206-2010 | VIPA Veronikis Intra-Fiberoptic Pelvic Assistant, Set Catalog No 350-370. VIPA Set... | Marina Medical Instruments Inc. | EXX | ||
| Z-1888-2009 | ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-1999-2009 | 300 Microliter CO-RE Tips for use with Microlab STAR, manufactured by Hamilton Company... | Hamilton Co | JTC | ||
| Z-1711-2009 | Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr , 40cm For... | Abbott Medical | EXQ | ||
| Z-1582-2009 | Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device... | Cardiomedics Incorporated | DRN | ||
| Z-1480-2009 | Biomet Optivac Total Hip Kit, Maximum Capacity Cartridge, 1 kit, sterile, latex free... | Zimmer GmbH | JDZ | ||
| Z-1504-2009 | AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle... | Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals | FMF | ||
| Z-0365-2010 | PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager... | Picis Clinical Solutions, Inc. | NSX | ||
| Z-1250-2010 | MaxTorque Cannulated Screw Model # MSD-010-55-060S | TORNIER Inc. | HWC | ||
| Z-1884-2011 | TEE Transducer V5M, when used with the Acuson S2000 Ultrasound System, software versions... | Siemens Medical Solutions USA, Inc. | IYO | ||
| Z-1990-2009 | BHM Combi Sling, 100% Polyester Shell/100% Polyester Strap; soft polyester net fabric... | Arjohuntleigh Magog, Inc. | FNG | ||
| Z-1728-2009 | Hologic Delphi series Bone Densitometer Software versions 12.6, 2.3., or... | Hologic, Inc. | KGI | ||
| Z-1727-2009 | Hologic QDR 4500 series Bone Densitometer Software versions 12.6, 2.3., or... | Hologic, Inc. | KGI | ||
| Z-1726-2009 | Hologic Explorer series Bone Densitometer System Software versions 12.6, 2.3., or... | Hologic, Inc. | KGI | ||
| Z-1725-2009 | Hologic Discovery series Bone Densitometer System Software versions 12.6, 2.3., or... | Hologic, Inc. | KGI | ||
| Z-0455-2010 | Tornier, LMP-50 (Lesser Metatarsal Phalangeal Implant), Size 50, Sterile EO... | TORNIER Inc. | KWH | ||
| Z-1417-2009 | CHIBA NEEDLE MARKED, Model CNM-1806, Size: 18 GA x 15 CM, Qty: 10 each, Remington... | Remington Medical | GDM | ||
| Z-1506-2009 | Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in... | Abbott Diagnostics Scarborough, Inc. | GTZ | ||
| Z-1080-2013 | Class II | Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system... | Stellate Systems | GWQ | |
| Z-1641-2009 | In Situ Bender Cutter Kit Narrow Sterile, Catalog number 530.522S. Used with Synthes'... | Synthes GmbH | HRS | ||
| Z-1640-2009 | In Situ Bender Cutter Kit Wide Sterile, Catalog number 530.521S Used with Synthes'... | Synthes GmbH | HRS | ||
| Z-1549-2009 | GE Centricity PACS (Picture Archiving and Communication System) software; GE Healthcare... | GE Healthcare | LLZ | ||
| Z-0871-2010 | PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek... | Polymer Technology Systems | CHH | ||
| Z-2312-2009 | Multi-Axial Screw (TI); 8.00MM (D) x 70MM(L) W/Collar; Biomet Spine, Parsippany, NJ... | Ebi, LLC | KWP |