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-1460-05 | VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label... | Ortho-Clinical Diagnostics, Inc. | LCD | ||
| Z-1587-05 | Alto DR (model 614) and Alto 2 DR (model 624) Implantable cardioverter Defibrillator... | Ela Medical, Inc. | MRM | ||
| Z-1106-05 | Staarvisic II Sodium Hyaluronate, 0.8 mL | Staar Surgical AG | LZP | ||
| Z-1388-05 | Access Immunoassay Systems Assay Protocol: Dil-AFP. | Siemens Healthcare Diagnostics Inc. | LOJ | ||
| Z-1421-05 | GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05 | GE Medical Systems Information Technologies, Inc. | LLZ | ||
| Z-1039-05 | CONTAK TR (Model no. 1241) pacemaker. Sterilized with gaseous ethylene oxide. Guidant... | Boston Scientific Corporation | LWP | ||
| Z-1038-05 | INTELIS II (model nos. 1349, 1384, 1385, 1483, 1484, 1485 and 1499) pacemaker... | Boston Scientific Corporation | LWP | ||
| Z-1037-05 | VIRTUS PLUS II (model nos. 1380 and 1480) pacemaker. Sterilized with gaseous ethylene... | Boston Scientific Corporation | LWP | ||
| Z-1036-05 | DISCOVERY II (model nos. 481, 981 1184, 1186, 1187, 1283, 1284, 1285 and 1286) pacemaker... | Boston Scientific Corporation | LWP | ||
| Z-1035-05 | PULSAR MAX II (model nos. 1180, 1181 and 1280) pacemaker. Sterilized with gaseous... | Boston Scientific Corporation | LWP | ||
| Z-1034-05 | PULSAR and PULSAR MAX (model nos. 470, 870, 970, 972, 1170, 1171, 1172, 1270 and 1272)... | Boston Scientific Corporation | LWP | ||
| Z-1033-05 | MERIDIAN (model nos. 476, 976, 1176 and 1276) pacemaker. Sterilized with gaseous... | Boston Scientific Corporation | LWP | ||
| Z-1032-05 | DISCOVERY (model nos. 1174, 1175, 1273, 1274 and 1275) pacemaker. Sterilized with... | Boston Scientific Corporation | LWP | ||
| Z-1456-05 | Boston Scientific brand Concerto Bipolar Needle Electrode, sterile, latex free, Model... | Boston Scientific Corporation | GEI | ||
| Z-1105-05 | Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number... | Roche Diagnostics GmbH | LZG | ||
| Z-1387-05 | Amvisc Plus Sodium Hyaluronate 0.8 mL. Bausch & Lomb, Inc., Rochester, NY Product... | Anika Therapeutics, Inc. | LZP | ||
| Z-1386-05 | Amvisc Plus Sodium Hyaluronate 0.5 mL. Bausch & Lomb, Inc., Rochester, NY Product Number... | Anika Therapeutics, Inc. | LZP | ||
| Z-1385-05 | Amvisc Sodium Hyaluronate 0.8 mL. Bausch & Lomb, Inc., Rochester, NY Product Numbr: 59081 | Anika Therapeutics, Inc. | LZP | ||
| Z-1384-05 | Amvisc Sodium Hyaluronate 0.5 mL. Bausch & Lomb, Inc., Rochester, NY Product Number: 59051 | Anika Therapeutics, Inc. | LZP | ||
| Z-1383-05 | ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use... | Anika Therapeutics, Inc. | LZP | ||
| Z-1382-05 | Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile. Rx. For intraocular use... | Anika Therapeutics, Inc. | LZP | ||
| Z-1380-05 | Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a... | Baxter Healthcare Renal Div | KDI | ||
| Z-1444-05 | TM-300 Traction System; an Rx software driven device used for patient traction... | Patterson Medical Holdings, Inc. | HST | ||
| Z-1043-05 | ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula sterile, in double pouch, 10... | ArthroCare Corporation | GEA | ||
| Z-0005-06 | Hard shell carry case for the LIFEPAK CR Plus. | Physio Control, Inc. | MKJ | ||
| Z-0004-06 | Hard shell carry case for the LIFEPAK 500 AED. | Physio Control, Inc. | MKJ | ||
| Z-1423-05 | BD Vacutainer Blood Transfer Device. It consists of a Luer attached via a hub to a... | Becton Dickinson & Co | JKA | ||
| Z-1083-05 | Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a... | Teleflex Medical | FCM | ||
| Z-1374-05 | Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test | Siemens Healthcare Diagnostics Inc. | GJT | ||
| Z-2334-2012 | Class II | SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is... | JK Products & Services, Inc | LEJ | |
| Z-1103-05 | Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8689; 6'', 0.33... | Baxter Healthcare Corporation | FPA | ||
| Z-1102-05 | Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; 9'', 0.8 mL... | Baxter Healthcare Corporation | FPA | ||
| Z-1101-05 | Baxter Interlink System Minivolume Extension Set, product code 1C8483; 18'', 1.3 mL Vol... | Baxter Healthcare Corporation | FPA | ||
| Z-1100-05 | Baxter Interlink System Minivolume Extension Set, product code 1C8462; 16'', 4.2 mL Vol... | Baxter Healthcare Corporation | FPA | ||
| Z-1377-05 | Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0 | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1373-05 | Baxter Healthcare Corporation, Medication Delivery Division, Syndeo PCA Syringe Pump... | Baxter Healthcare Corporation | MEA | ||
| Z-1099-05 | Baxter Interlink System Minivolume Extension Set, product code 1C8290; 11'', 0.86 mL... | Baxter Healthcare Corporation | FPA | ||
| Z-1111-05 | Medtronic Neurosurgery C/n 3805-015 Peelaway Introducer Sheath, Disposable 15 F | Medtronic Neurosurgery | GWG | ||
| Z-1110-05 | Medtronic Neurosurgery C/N 3805-014 Peelaway Introducer Sheath, Disposable 14 F | Medtronic Neurosurgery | GWG | ||
| Z-1396-05 | Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety... | Maquet Cardiovascular LLC | DYB | ||
| Z-0075-06 | CRITIFLO(tm) FLUSH KIT | Becton Dickinson Infusion Therapy Systems Inc. | KRA | ||
| Z-0074-06 | CRITIFLO(tm) flush kit. | Becton Dickinson Infusion Therapy Systems Inc. | KRA | ||
| Z-0073-06 | DT-DL60-1 W/Bifurcated | Becton Dickinson Infusion Therapy Systems Inc. | KRA | ||
| Z-0072-06 | CRITIFLO(tm) TAK0460 continuous flow catheter | Becton Dickinson Infusion Therapy Systems Inc. | KRA | ||
| Z-0071-06 | TAKHPQ60R continuous flow catheter. | Becton Dickinson Infusion Therapy Systems Inc. | KRA | ||
| Z-0070-06 | CRITIFLOW(tm) TA4004 continuous flush catheter | Becton Dickinson Infusion Therapy Systems Inc. | KRA | ||
| Z-0069-06 | DTX(tm) Plus DT-DL60 Continuous flush catheter | Becton Dickinson Infusion Therapy Systems Inc. | KRA | ||
| Z-1565-05 | BD DTX Plus, Custom dual-line pressure monitoring kit. | Becton Dickinson Infusion Therapy Systems Inc. | DXN | ||
| Z-1564-05 | BD DTX Plus, Custom triple-line pressure monitoring kit. | Becton Dickinson Infusion Therapy Systems Inc. | DXN | ||
| Z-1563-05 | BD DTX Plus, Custom single-line pressure monitoting kit. | Becton Dickinson Infusion Therapy Systems Inc. | DXN |