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-0080-2008 | ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. Distal... | Howmedica Osteonics Corp | KWS | ||
| Z-1220-2007 | IVF Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of 30... | CooperSurgical, Inc. | MQK | ||
| Z-1072-2007 | STA Liatest Free Protein S For in vitro diagnostic use. 2-8 degrees C Distributed in the... | Diagnostica Stago, Inc. | GGP | ||
| Z-1158-2007 | Precision Bipolar Device 6 pack Consists of a six-pack of the Precision Bipolar... | Datascope Corp. | GEI | ||
| Z-1157-2007 | The ClearGlide EVH small with Scissors. The kit includes three Precision Bipolar Devices... | Datascope Corp. | GEI | ||
| Z-1156-2007 | Precision Bipolar Device ClearGlide EVH Small (endoscopic vessel harvesting system) The... | Datascope Corp. | GEI | ||
| Z-1009-2007 | Stryker Medical -Wheeled Electric Stretcher, Model 1550 (with and without scales) | Stryker Medical | FPO | ||
| Z-2033-2008 | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2032-2008 | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2031-2008 | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2030-2008 | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2029-2008 | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2028-2008 | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2027-2008 | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2026-2008 | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2025-2008 | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2024-2008 | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2023-2008 | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2022-2008 | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2021-2008 | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2020-2008 | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2019-2008 | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2018-2008 | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2017-2008 | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - FC 500... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2016-2008 | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - FC 500 with... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0832-2007 | EnDura No-React Dural Substitute 12 cm Diameter | Integra LifeSciences Corporation | DTZ | ||
| Z-0831-2007 | EnDura No React Dural Substitute 10 cm x 12 cm | Integra LifeSciences Corporation | DTZ | ||
| Z-0830-2007 | Endura No-React Dural Substitute 6 cm x 10 cm | Integra LifeSciences Corporation | DTZ | ||
| Z-0829-2007 | EnDura No-React Dural Substitute 5 cm x 6 cm | Integra LifeSciences Corporation | |||
| Z-0828-2007 | EnDura No-React Dural Substitute 4 cm X 4 cm. | Integra LifeSciences Corporation | DTZ | ||
| Z-0827-2007 | Endura No-React Dural Substitute 2 cm x 10 cm | Integra LifeSciences Corporation | DTZ | ||
| Z-1244-2007 | Endoscopic Instrument Control System (da Vinci Surgical System) Model IS1200, A4.3 SW... | Intuitive Surgical, Inc. | NAY | ||
| Z-0145-2008 | Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch... | Hologic, Inc. | MDK | ||
| Z-0003-2008 | BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro... | Meretek Diagnostics, Inc. | MSQ | ||
| Z-1074-2007 | Varian Medical Systems Clinac Medical Linear Accelerator. Clinac 600 C &C/D, Clinac 2100... | Varian Medical Systems, Inc. | IYE | ||
| Z-0890-2007 | Sienet MagicStore. Radiological Digital Image Communications System | Siemens Medical Solutions USA, Inc. | LMD | ||
| Z-0888-2007 | Patrol enteral pump set with piercing pin, list #520540. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-2165-2008 | Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm REF... | Boston Scientific Corporation | LOX | ||
| Z-1077-2007 | DCI Equipment Track Mount Light Assembly, 110v | DCI International, LLC | EAZ | ||
| Z-1161-2007 | Boston Scientific NexStent Monorail 5F Carotid Stent and Monorail Delivery System... | Boston Scientific Corporation | NIM | ||
| Z-0955-2007 | Angiojet XMI Rapid Exchange, catheters, 135 cm, 4 F, Single Use Only, Sterilized with... | Possis Medical, Inc. | DXE | ||
| Z-0954-2007 | Angiojet Spiroflex, Catheter, 135 cm, 4F, Single use only, Sterilized with Ethylene... | Possis Medical, Inc. | MCX | ||
| Z-0984-2007 | Panorama 1.0T MRI | Philips North America LLC | LNH | ||
| Z-0983-2007 | Achieva MRI | Philips North America LLC | LNH | ||
| Z-0982-2007 | Intera MRI | Philips North America LLC | LNH | ||
| Z-0981-2007 | Gyroscan MRI | Philips North America LLC | LNH | ||
| Z-0953-2007 | ARCHITECT c16000 Processing Module, for in vitro diagnostics; List Number 3L77-01... | Abbott Medical | JJE | ||
| Z-0952-2007 | ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01... | Abbott Medical | JJE | ||
| Z-0951-2007 | ARCHITECT i2000sr Processing Module, for in vitro diagnostics; List Number 3M74-01... | Abbott Medical | JJE | ||
| Z-0950-2007 | ARCHITECT i2000 Processing Module, for in vitro diagnostics; List Number 8C89-01; v2.10... | Abbott Medical | JJE |