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-1511-06 | Solara Spree XT (SPRXT) manual wheelchair. | Invacare GmbH | IOR | ||
| Z-1510-06 | Solara Spree GT manual wheelchair. | Invacare GmbH | IOR | ||
| Z-1509-06 | Solara 2G manual wheelchair. | Invacare GmbH | IOR | ||
| Z-1378-06 | Accu-Chek Advantage blood glucose test strips; U.S. Reference nos. (packaged in 50s... | Roche Diagnostics GmbH | LFR | ||
| Z-1377-06 | Accu-Chek Comfort Curve blood glucose test strips; (packaged in 10s, 50s, and/or 100s)... | Roche Diagnostics GmbH | LFR | ||
| Z-1429-06 | Cobe CML Duo Flat Sheet Membrane Oxygenator, Non-sterile, Catalog Number: 436122974... | LivaNova USA, Inc. | DTZ | ||
| Z-1428-06 | Cobe Optima XP Hollow Fiber Membrane Oxygenator, Non-Sterile, Catalog Number 436422974... | LivaNova USA, Inc. | DTZ | ||
| Z-1427-06 | Cobe Optimin Hollow Fiber Sealed System, Sterile, (Custom Heart / Lung Pack), Catalog... | LivaNova USA, Inc. | DTZ | ||
| Z-1426-06 | Cobe CML Duo Flat Sheet Membrane Oxygenator, sterile, (Custom Heart/Lung Packs), Catalog... | LivaNova USA, Inc. | DTZ | ||
| Z-1425-06 | Cobe Optima XP Hollow Fiber Membrane Oxygenator, Sterile, (Custom Heart/Lung Packs)... | LivaNova USA, Inc. | DTZ | ||
| Z-1424-06 | Cobe Optimin Hollow Fiber Sealed System, Oxygenator/Reservoir, Sterile, (Standalone... | LivaNova USA, Inc. | DTZ | ||
| Z-1423-06 | Cobe CML Duo Flat Sheet Membrane Oxygenator/Reservoir, sterile, (Standalone systems)... | LivaNova USA, Inc. | DTZ | ||
| Z-1422-06 | Cobe Optima XP Hollow Fiber Membrane Oxygenator/Reservoir, Sterile, (Standalone Systems)... | LivaNova USA, Inc. | DTZ | ||
| Z-1351-06 | Zimmer Herbert Cannulated Bone Screw System Bone Screw, 4.5 mm dia., 50 mm length... | Zimmer GmbH | HWC | ||
| Z-1350-06 | Zimmer Herbert Cannulated Bone Screw System Bone Screw, 4.5 mm dia., 45 mm length... | Zimmer GmbH | HWC | ||
| Z-1349-06 | Zimmer Herbert Cannulated Bone Screw System Bone Screw, 6.5 mm dia., 35 mm length... | Zimmer GmbH | HWC | ||
| Z-1348-06 | Zimmer Herbert Cannulated Bone Screw System Bone Screw, 4.5 mm dia., 25 mm length... | Zimmer GmbH | HWC | ||
| Z-1347-06 | Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia., 40 mm length... | Zimmer GmbH | HWC | ||
| Z-1346-06 | Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia., 35 mm length... | Zimmer GmbH | HWC | ||
| Z-1345-06 | Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia., 30 mm length... | Zimmer GmbH | HWC | ||
| Z-1344-06 | Zimmer Bone Screw, self tapping, 6.5 mm dia., 20 mm length, tivanium TI-6AL-4V alloy... | Zimmer GmbH | HWC | ||
| Z-1343-06 | Zimmer M/DN Intramedullary Fixation 5.5 dia. cortical screw, 3.5 mm hex head, 100 mm... | Zimmer GmbH | NDJ | ||
| Z-1342-06 | Zimmer M/DN Intramedullary Fixation 5.5 dia. cortical screw, 3.5 mm hex head, 95 mm... | Zimmer GmbH | NDJ | ||
| Z-1341-06 | Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head, 85 mm... | Zimmer GmbH | NDJ | ||
| Z-1340-06 | Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head, 75 mm... | Zimmer GmbH | NDJ | ||
| Z-1339-06 | Zimmer M/DN Intramedullary Fixation 5.5 dia. cortical screw, 3.5 mm hex head, 70 mm... | Zimmer GmbH | NDJ | ||
| Z-1338-06 | Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head, 70 mm... | Zimmer GmbH | NDJ | ||
| Z-1337-06 | Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head, 65 mm... | Zimmer GmbH | NDJ | ||
| Z-1336-06 | Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head, 55 mm... | Zimmer GmbH | NDJ | ||
| Z-1335-06 | Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head, 52.5 mm... | Zimmer GmbH | NDJ | ||
| Z-1466-06 | FP1000 Cell Preparation System Part Number 624922 | Siemens Healthcare Diagnostics Inc. | LXG | ||
| Z-1240-06 | Cordis INFINITI 6 French Diagnostic Catheter. Catalog 534-6xxT. That is: 534614T... | Cordis US Corp. | DQO | ||
| Z-1239-06 | Aksys PHD Personal Hemodialysis System for daily home hemodialysis; an automated high... | Aksys, Ltd. | KDI | ||
| Z-1299-06 | VITALITY (models 1870, 1871, T125, T127, T135) and VITALITY 2 (models T165, T167, T175... | Boston Scientific Corporation | LWP | ||
| Z-1298-06 | CONTAK RENEWAL TR (models H120, H125) and CONTAK RENEWAL TR2 (models H140, H145). CONTAK... | Boston Scientific Corporation | NKE | ||
| Z-1297-06 | Guidant VENTAK PRIZM VR (model 1860) and VENTAK PRIZM DR (model 1861) Automatic... | Boston Scientific Corporation | KRG | ||
| Z-1296-06 | Guidant INSIGNIA I AVT --family of pacemakers includes the following: SSI (model 482)... | Boston Scientific Corporation | LWP | ||
| Z-1295-06 | Guidant INSIGNIA I Plus --family of pacemakers includes the following: SR (models1194)... | Boston Scientific Corporation | LWP | ||
| Z-1294-06 | Guidant INSIGNIA I Ultra --family of pacemakers includes the following: SR (models1190)... | Boston Scientific Corporation | LWP | ||
| Z-1293-06 | Guidant INSIGNIA I Entra-- family of pacemakers includes the following: SSI (model... | Boston Scientific Corporation | LWP | ||
| Z-1517-06 | Terumo Khuri Myocardial Ph Monitoring System, Catalog Number 7205 | Terumo Cardiovascular Systems Corporation | CBZ | ||
| Z-0054-2007 | ApexPro FH Telemetry System: composed of six major components (as follows); Accessories... | GE Healthcare | MHX | ||
| Z-0975-2007 | SafeClinitubes, REF 942-892, D957P-70-100x1, contained in kits containing 250... | Radiometer America, Inc | GIO | ||
| Z-1408-06 | Amsco Sonic Energy Console, Part Nos.: B602047470, P080000002, P080000003, B018905015... | STERIS Corporation | FLG | ||
| Z-1407-06 | Steris Amsco Sonic Energy Cleaner, Part Nos.: P080000005, B018905020, B018905JBJ, and... | STERIS Corporation | FLG | ||
| Z-1371-06 | ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter and Voice Unit - Spanish... | Roche Diagnostics GmbH | LFR | ||
| Z-1370-06 | ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter and Voice Unit - English... | Roche Diagnostics GmbH | LFR | ||
| Z-1369-06 | ACCU-CHEK Advantage FPO Diabetes Monitoring Kit, Cat. no. 3271358001. Ref. no... | Roche Diagnostics GmbH | CGA | ||
| Z-1368-06 | GTS Advantage Meter. Cat. no. 424. Ref. no. 03144780001 with meter model no. 777. | Roche Diagnostics GmbH | CGA | ||
| Z-1367-06 | AccuData GTS Plus AccuData GTS For Blood Glucose Monitoring and Automated Data... | Roche Diagnostics GmbH | CGA |