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-1355-2014 | Class II | Syphilis Test Card (Serum); LumiQuick. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1354-2014 | Class II | Salmonella typhi IgG/IgM Duo Test; LumiQuick. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1353-2014 | Class II | Salmonella typhi/paratyphi Antigen Test; LumiQuick. Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1352-2014 | Class II | Malaria pan Antigen Test; LumiQuick, Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1351-2014 | Class II | Malaria pf Antigen Test Card; Flumiquil, Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1350-2014 | Class II | Malaria pf Antigen Test Card; LumiQuick, Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1349-2014 | Class II | Strep A Test Card; LumiQuick, Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1348-2014 | Class II | H. Pylori Ab Test Card-Serum; LumiQuick, Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1347-2014 | Class II | Legionella Test Card; LumiQuick, Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1346-2014 | Class II | Adeno/Rota Combo Test Card; LumiQuick, Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1345-2014 | Class II | Adenovirus Antigen Test Card; LumiQuick, Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1344-2014 | Class II | Rotavirus Test Card LumiQuick, Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1343-2014 | Class II | Salmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1342-2014 | Class II | H. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1341-2014 | Class II | H. Pylori Antigen Test Card LumiQuick, Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1340-2014 | Class II | Dengue IgG/IgM; LumiQuick, Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1339-2014 | Class II | Rickettsia IgG/IgM Test Card LumiQuick, Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1338-2014 | Class II | Syphilis Test Card Whole Blood(Serum) LumiQuick, Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1337-2014 | Class II | Syphilis Test Strip (Serum) LumiQuick, Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | ||
| Z-1506-2014 | Class II | Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802... | Teleflex Medical | KNT | |
| Z-1230-2014 | Class I | Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is... | Abbott Medical | DSQ | |
| Z-229-2014 | Class I | HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate II is a... | Abbott Medical | DSQ | |
| Z-1228-2014 | Class I | HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that... | Abbott Medical | DSQ | |
| Z-1227-2014 | Class I | HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed... | Abbott Medical | DSQ | |
| Z-1302-2014 | Class II | Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use... | Biocardia, Inc. | DYB | |
| Z-1301-2014 | Class II | Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use... | Biocardia, Inc. | DYB | |
| Z-1164-2014 | Class II | Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664. | Boston Scientific Corporation | DQY | |
| Z-1305-2014 | Class II | FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum... | Medtronic, Inc. | NTE | |
| Z-1304-2014 | Class II | FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm, Maximum... | Medtronic, Inc. | NTE | |
| Z-1303-2014 | Class II | FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum... | Medtronic, Inc. | NTE | |
| Z-1224-2014 | Class II | Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" flare The Sarns Malleable... | Terumo Cardiovascular Systems Corporation | DWF | |
| Z-1223-2014 | Class II | Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare The Sarns Malleable... | Terumo Cardiovascular Systems Corporation | DWF | |
| Z-1222-2014 | Class II | Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38... | Terumo Cardiovascular Systems Corporation | DWF | |
| Z-1221-2014 | Class II | Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38... | Terumo Cardiovascular Systems Corporation | DWF | |
| Z-1220-2014 | Class II | Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38... | Terumo Cardiovascular Systems Corporation | DWF | |
| Z-1219-2014 | Class II | Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5"... | Terumo Cardiovascular Systems Corporation | DWF | |
| Z-1218-2014 | Class II | Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5"... | Terumo Cardiovascular Systems Corporation | DWF | |
| Z-1264-2014 | Class II | Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and... | Philips North America LLC | IYN | |
| Z-1263-2014 | Class II | Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and... | Philips North America LLC | IYN | |
| Z-1231-2014 | Class II | Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated... | Teleflex Medical | BTS | |
| Z-1315-2014 | Class II | Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part... | Roche Diagnostics GmbH | ||
| Z-1175-2014 | Class II | GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE... | GE Healthcare | MHX | |
| Z-1526-2014 | Class II | Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including the external... | Medtronic Neuromodulation | LGW | |
| Z-1297-2014 | Class II | Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway... | Endologix LLC | MIH | |
| Z-1151-2014 | Class II | Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable... | Megadyne Medical Products, Inc | GEI | |
| Z-1299-2014 | Class II | D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad... | Bio-Rad Laboratories Inc. | LCP | |
| Z-1300-2014 | Class II | PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated... | Bard Access Systems, Inc. | LJT | |
| Z-1525-2014 | Class II | Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603)... | Medtronic Neuromodulation | MHY | |
| Z-1524-2014 | Class II | Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED... | Medtronic Neuromodulation | LGW | |
| Z-1698-2014 | Class II | Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi... | Leica Microsystems, Inc. | NJT |