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-0543-2013 | Class II | Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed... | Zimmer GmbH | JWH | |
| Z-0542-2013 | Class II | Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed... | Zimmer GmbH | JWH | |
| Z-0541-2013 | Class II | Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed... | Zimmer GmbH | JWH | |
| Z-0540-2013 | Class II | Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed... | Zimmer GmbH | JWH | |
| Z-0539-2013 | Class II | Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed... | Zimmer GmbH | JWH | |
| Z-0521-2013 | Class II | Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase... | Leica Microsystems, Inc. | NJT | |
| Z-0512-2013 | Class II | Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50... | Siemens Healthcare Diagnostics Inc. | KLS | |
| Z-0511-2013 | Class II | Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test... | Siemens Healthcare Diagnostics Inc. | CGN | |
| Z-0510-2013 | Class II | Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test... | Siemens Healthcare Diagnostics Inc. | LFM | |
| Z-0509-2013 | Class II | Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur... | Siemens Healthcare Diagnostics Inc. | JKC | |
| Z-0508-2013 | Class II | Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended... | Siemens Healthcare Diagnostics Inc. | NIG | |
| Z-0507-2013 | Class II | Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref... | Siemens Healthcare Diagnostics Inc. | MOI | |
| Z-0506-2013 | Class II | Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test... | Siemens Healthcare Diagnostics Inc. | NBC | |
| Z-0522-2013 | Class II | Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole... | Roche Diagnostics GmbH | CHL | |
| Z-0436-2013 | Class II | 220/240V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion... | Terumo Cardiovascular Systems Corporation | DTQ | |
| Z-0435-2013 | Class II | 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion... | Terumo Cardiovascular Systems Corporation | DTQ | |
| Z-1815-2013 | Class II | Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor... | Leica Microsystems, Inc. | IEO | |
| Z-0441-2013 | Class II | The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set... | Medtronic Navigation, Inc | HAW | |
| Z-0756-2013 | Class II | BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD... | Becton Dickinson & Co | JKA | |
| Z-0571-2013 | Class II | SpineSix consists of a motorized treatment table that is controlled by an integral... | BioMotion Medical Systems, LLC | BXB | |
| Z-0594-2013 | Class I | Zimmer Spine Ardis Inserter, Rx, non-sterile | Zimmer GmbH | MAX | |
| Z-0611-2013 | Class II | Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no... | Greatbatch Medical | DYB | |
| Z-1399-2013 | Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot... | DSM Biomedical, Inc. | OAR | |
| Z-1398-2013 | Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot... | DSM Biomedical, Inc. | OAR | |
| Z-1397-2013 | Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot... | DSM Biomedical, Inc. | OAR | |
| Z-1396-2013 | Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot... | DSM Biomedical, Inc. | OAR | |
| Z-1395-2013 | Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot... | DSM Biomedical, Inc. | OAR | |
| Z-1394-2013 | Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot... | DSM Biomedical, Inc. | OAR | |
| Z-1393-2013 | Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot... | DSM Biomedical, Inc. | OAR | |
| Z-1392-2013 | Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot... | DSM Biomedical, Inc. | OAR | |
| Z-1391-2013 | Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot... | DSM Biomedical, Inc. | OAR | |
| Z-1390-2013 | Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot... | DSM Biomedical, Inc. | OAR | |
| Z-1389-2013 | Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot... | DSM Biomedical, Inc. | OAR | |
| Z-1388-2013 | Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot... | DSM Biomedical, Inc. | OAR | |
| Z-1387-2013 | Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot... | DSM Biomedical, Inc. | OAR | |
| Z-1849-2013 | Class II | GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general... | GE Healthcare | IYN | |
| Z-1871-2013 | Class II | Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse... | SPINEFRONTIER, Inc. dba LESspine Innovations | FZX | |
| Z-0527-2013 | Class II | EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System... | Zimmer GmbH | KTT | |
| Z-0631-2013 | Class II | AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses | COOPERVISION Manufacturing Puerto Rico, LLC | LPL | |
| Z-0497-2013 | Class I | Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40... | Medtronic Neuromodulation | LKK | |
| Z-0496-2013 | Class I | SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18... | Medtronic Neuromodulation | LKK | |
| Z-0495-2013 | Class II | Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX... | Philips North America LLC | MHX | |
| Z-0994-2013 | Class II | Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in... | Canon Medical Systems USA, Inc. | MQB | |
| Z-1052-2013 | Class I | ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to... | Howmedica Osteonics Corp | MBH | |
| Z-0568-2013 | Class II | Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription... | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-0294-2013 | Class II | EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers... | Zevex, Inc. | LZH | |
| Z-0693-2013 | Class II | Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG... | Quanta System Inc. | GEX | |
| Z-0692-2013 | Class II | Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction... | Quanta System Inc. | GEX | |
| Z-0691-2013 | Class II | Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of... | Quanta System Inc. | GEX | |
| Z-0697-2013 | Class II | 25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D... | IDS (Immunodiagnostic Systems Ltd.) | MRG |