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-2349-2008 | Rejuvenate Broach Catalog No: 1601-1005, 1601-1006, 1601-1007, 1601-1008, 1601-1009... | Howmedica Osteonics Corp | HTQ | ||
| Z-2004-2008 | Esprit Power Supply Field Replacement Unit (FRU), PN 101 8246 The Esprit Ventilator is a... | Respironics, Inc. | CBK | ||
| Z-2003-2008 | Esprit Power Supply Snubber Board Assembly FRU, PN 1036236 The Esprit Ventilator is a... | Respironics, Inc. | CBK | ||
| Z-2002-2008 | Esprit Ventilator, Model V1000 manufactured with Power Supply PN 1015852 The Esprit... | Respironics, Inc. | CBK | ||
| Z-1471-2008 | Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number... | Biogenex Laboratories, Inc. | KEY | ||
| Z-1177-2008 | CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed... | California Medical Laboratories, Inc. | DTS | ||
| Z-1176-2008 | CalMed Pericardial Sump, with 1/4"/0.635 cm Connector, Single Use Only. Do Not Reuse; REF... | California Medical Laboratories, Inc. | DTS | ||
| Z-1175-2008 | CalMed Pericardial Sump, with 1/8"/0.3175 cm Connector Single Use Only. Do Not Reuse... | California Medical Laboratories, Inc. | DTS | ||
| Z-1140-2008 | B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K... | B & K Medical Systems, Inc. | IYN | ||
| Z-0855-2010 | Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann... | Cybernet Systems Co., Ltd. | DXH | ||
| Z-0854-2010 | Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann... | Cybernet Systems Co., Ltd. | DXH | ||
| Z-0853-2010 | Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann... | Cybernet Systems Co., Ltd. | DXH | ||
| Z-0852-2010 | Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann... | Cybernet Systems Co., Ltd. | DXH | ||
| Z-1714-2008 | Electrode Adaptor Cable Quick-Combo System, Model 9055 The 9055 Electrode Adaptor is... | ZOLL Medical Corporation | MKJ | ||
| Z-1616-2008 | 9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System... | ZOLL Medical Corporation | MKJ | ||
| Z-1174-2008 | Trident PSL HA Cluster: 40 mm to 72 mm, hip prosthesis component, Stryker Orthopaedics... | Howmedica Osteonics Corp | MEH | ||
| Z-1173-2008 | Trident PSL Acetabular Shells; Trident PSL HA Solid Back, 40 mm to 73 mm, hip prosthesis... | Howmedica Osteonics Corp | MEH | ||
| Z-1172-2008 | Trident Hemispherical Multi Arc Deposited; Hydroxylapatite Coated; Multiholed; Use with... | Howmedica Osteonics Corp | MEH | ||
| Z-1171-2008 | Trident Hemispherical HA Cluster, 42 mm - 74mm Arc Deposited; Hydroxylapatite Coated... | Howmedica Osteonics Corp | MEH | ||
| Z-1170-2008 | Trident Hemispherical Cluster; 42mm - 74 mm Arc Deposited; Hydroxylapatite Coated... | Howmedica Osteonics Corp | MEH | ||
| Z-1169-2008 | Trident Hemispherical Acetabular Shells HA Solid BK 42mm- 74mm; Arc... | Howmedica Osteonics Corp | MEH | ||
| Z-1462-2008 | AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La... | Abbott Medical | DKZ | ||
| Z-1168-2008 | Trident Hemispherical Solid BK Acetabular Shells; 42mm to 74mm, Hydroxylapatite Coated... | Howmedica Osteonics Corp | MEH | ||
| Z-1749-2008 | UBiT-IR300 Infrared Spectrophotometer, Software Versions 7.0, 7.01 and 7.11. | Otsuka America Pharmaceutical, Inc | JJQ | ||
| Z-1131-2008 | ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-36, ev3, 4600... | Medtronic, Inc. | FGE | ||
| Z-1130-2008 | ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-26, ev3, 4600... | Medtronic, Inc. | FGE | ||
| Z-1129-2008 | ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-16, ev3, 4600... | Medtronic, Inc. | FGE | ||
| Z-1128-2008 | ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-36, ev3, 4600... | Medtronic, Inc. | FGE | ||
| Z-1127-2008 | ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-26, ev3, 4600... | Medtronic, Inc. | FGE | ||
| Z-1126-2008 | ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-16, ev3, 4600... | Medtronic, Inc. | FGE | ||
| Z-1125-2008 | ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-36, ev3... | Medtronic, Inc. | FGE | ||
| Z-1124-2008 | ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-16, ev3... | Medtronic, Inc. | FGE | ||
| Z-1123-2008 | ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-36, ev3, 4600 Nathan Lane... | Medtronic, Inc. | FGE | ||
| Z-1122-2008 | ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-26, ev3, 4600 Nathan Lane... | Medtronic, Inc. | FGE | ||
| Z-1121-2008 | ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-16, ev3, 4600 Nathan Lane... | Medtronic, Inc. | FGE | ||
| Z-1120-2008 | ev3 IntraStent Biliary Stent, Model Number: S10-26, ev3, 4600 Nathan Lane North... | Medtronic, Inc. | FGE | ||
| Z-1654-2008 | ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory Device) | Radiometer America, Inc | CHL | ||
| Z-1653-2008 | ABL700 Series analyzer - Human Blood Analyzer (Laboratory Device). | Radiometer America, Inc | CHL | ||
| Z-1347-2008 | Implantable Cardioverter Defibrillator ATLAS II+ HF Tiered-therapy... | Abbott Medical | |||
| Z-1346-2008 | Implantable Cardioverter Defibrillator ATLAS II+ HF Tiered-therapy... | Abbott Medical | |||
| Z-1345-2008 | Implantable Cardioverter Defibrillator ATLAS II HF Tiered-therapy... | Abbott Medical | |||
| Z-1344-2008 | Implantable Cardioverter Defibrillator ATLAS II+ DR Tiered-therapy... | Abbott Medical | |||
| Z-1343-2008 | Implantable Cardioverter Defibrillator ATLAS II DR Tiered-therapy... | Abbott Medical | |||
| Z-1342-2008 | Implantable Cardioverter Defibrillator ATLAS II VR Tiered-therapy... | Abbott Medical | |||
| Z-1341-2008 | Implantable Cardioverter Defibrillator ATLAS + HF Tiered-therapy... | Abbott Medical | |||
| Z-1340-2008 | Implantable Cardioverter Defibrillator ATLAS + HF Tiered-therapy... | Abbott Medical | |||
| Z-1339-2008 | Implantable Cardioverter Defibrillator ATLAS + HF Tiered-therapy... | Abbott Medical | |||
| Z-1338-2008 | Implantable Cardioverter Defibrillator ATLAS + DR Tiered-therapy... | Abbott Medical | |||
| Z-1337-2008 | Implantable Cardioverter Defibrillator ATLAS DR Tiered-therapy... | Abbott Medical | |||
| Z-1336-2008 | Implantable Cardioverter Defibrillator ATLAS + VR Tiered-therapy... | Abbott Medical |