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-1522-2014 | Class II | Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23... | Integra LifeSciences Corporation | LFL | |
| Z-1510-2014 | Class II | Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex... | Philips North America LLC | KPS | |
| Z-1442-2014 | Class I | SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This... | GE Healthcare | CBK | |
| Z-1693-2015 | Class II | Neusoft NeuViz 64 Multi-slice CT Scanner System | Neusoft Medical System Co | JAK | |
| Z-2086-2014 | Class II | NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number... | Exactech, Inc. | LZO | |
| Z-1331-2014 | Class II | Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-1265-2014 | Class II | Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton... | Clarity Medical Systems | HKI | |
| Z-1478-2014 | Class II | API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF... | bioMerieux, Inc. | LIB | |
| Z-1477-2014 | Class II | API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and... | bioMerieux, Inc. | LIB | |
| Z-1476-2014 | Class II | FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results... | bioMerieux, Inc. | LIB | |
| Z-1475-2014 | Class II | ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the... | bioMerieux, Inc. | LIB | |
| Z-1464-2014 | Class II | Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems... | Philips North America LLC | KPS | |
| Z-0960-2015 | Class II | Symbia T and Symbia T2 computer tomography systems. These systems are used to perform... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-1611-2014 | Class II | DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for... | Datascope Corp. | MHX | |
| Z-1530-2014 | Class II | Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For... | Alfa Wassermann | CIT | |
| Z-1529-2014 | Class II | Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For... | Alfa Wassermann | CKA | |
| Z-1472-2014 | Class II | Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue... | Orthopediatrics Canada ULC | HSB | |
| Z-1470-2014 | Class II | VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics... | Ortho-Clinical Diagnostics, Inc. | KLT | |
| Z-1460-2014 | Class II | AXIOM Vertix MD Trauma systems radiographic X-ray | Siemens Medical Solutions USA, Inc. | IZZ | |
| Z-1441-2014 | Class II | FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical... | Remington Medical | DSA | |
| Z-1311-2014 | Class II | Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System... | ZOLL Medical Corporation | MKJ | |
| Z-1440-2014 | Class I | Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number... | Draeger Medical Systems, Inc. | BTL | |
| Z-1271-2014 | Class II | MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton... | Mevion Medical Systems, Inc. | LHN | |
| Z-1416-2014 | Class II | CK-MB Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1415-2014 | Class II | CK-MB Test Card (serum); LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1414-2014 | Class II | Myoglobin Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1413-2014 | Class II | Myoglobin Test Card (Serum); LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1412-2014 | Class II | Cardiac Panel Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1411-2014 | Class II | Cardiac Panel Test (Serum); LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1410-2014 | Class II | Troponin I test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1409-2014 | Class II | Troponin I test Card (serum); LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1408-2014 | Class II | K2 (synthetic Marijuana) Test card; LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1407-2014 | Class II | K2 (synthetic Marijuana) Test Strip; LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1406-2014 | Class II | Clonazepam Test Card; LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1405-2014 | Class II | Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1404-2014 | Class II | Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1403-2014 | Class II | Fentanyl Test Strip; LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1402-2014 | Class II | Methylphenidate Test Card; LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1401-2014 | Class II | Methylphenidate Test Strip; LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1400-2014 | Class II | Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1399-2014 | Class II | Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1398-2014 | Class II | Alcohol Test, Urine; LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1397-2014 | Class II | Oxycodone Test Card; LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1396-2014 | Class II | Oxycodone Strip; LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1395-2014 | Class II | Buprenorphine Test Card; LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1394-2014 | Class II | Buprenorphine Test Strip; LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1393-2014 | Class II | Ketamine Test Card; LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1392-2014 | Class II | Ketamine Strip; LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1391-2014 | Class II | THC Test Card; LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1390-2014 | Class II | THC Strip; LumiQuick,. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. |