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-3267-2011 | ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401819... | Angiodynamics Worldwide Headquarters | KRA | ||
| Z-3266-2011 | ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401818... | Angiodynamics Worldwide Headquarters | KRA | ||
| Z-1690-2011 | DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy... | Depuy Orthopaedics Inc. | JDK | ||
| Z-1689-2011 | DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 3, Sterile, DePuy... | Depuy Orthopaedics Inc. | JDK | ||
| Z-1688-2011 | DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy... | Depuy Orthopaedics Inc. | JDK | ||
| Z-1687-2011 | DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 4, Sterile, DePuy... | Depuy Orthopaedics Inc. | JDK | ||
| Z-1686-2011 | DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 1, Sterile, DePuy... | Depuy Orthopaedics Inc. | JDK | ||
| Z-1831-2011 | The enGenTM Laboratory Automation System consists of 3 main components including... | Ortho-Clinical Diagnostics, Inc. | JJE | ||
| Z-1862-2011 | Xcelerate Specialty Patella Milling System Per File K2399; Catalog Number I-K2399PR00... | Howmedica Osteonics Corp | HTJ | ||
| Z-1434-2011 | Cardiovascular Review Station The IMPAX Cardiovascular suite is a cardiovascular... | AGFA Healthcare Corp. | LLZ | ||
| Z-1386-2011 | AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated... | Baxter Healthcare Corporation | LHI | ||
| Z-1385-2011 | AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated... | Baxter Healthcare Corporation | LHI | ||
| Z-1384-2011 | AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition... | Baxter Healthcare Corporation | LHI | ||
| Z-1383-2011 | AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders... | Baxter Healthcare Corporation | LHI | ||
| Z-1697-2011 | Liko Capella 201 Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are... | Hill-Rom Inc. | FSA | ||
| Z-1696-2011 | Liko Sabina 200 Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are... | Hill-Rom Inc. | FSA | ||
| Z-1695-2011 | Liko Sabina Comfort Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are... | Hill-Rom Inc. | FSA | ||
| Z-1694-2011 | Liko Sabina II EM Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are... | Hill-Rom Inc. | FSA | ||
| Z-1693-2011 | Liko Sabina EM Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are... | Hill-Rom Inc. | FSA | ||
| Z-1692-2011 | Liko Sabina II EE Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are... | Hill-Rom Inc. | FSA | ||
| Z-1691-2011 | Liko Sabina EE Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are... | Hill-Rom Inc. | FSA | ||
| Z-2158-2011 | GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT system | GE Healthcare | IWE | ||
| Z-2153-2011 | Circumcision Clamp, models 1.1 cm and 1.3 cm, Circumcision clamp is an instrument used... | Surgical Design Inc | HFX | ||
| Z-1940-2011 | UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems; Part Number(s): DxC... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1939-2011 | UniCel DxI 600 Access Immunoassay Systems; Part Number(s): DxI 600: A30260, DxI 600 with... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1938-2011 | UniCel DxI 800 Access Immunoassay Systems; Part Number(s): DxI 800: 973100, DxI 800... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1818-2011 | Access Thyroglobulin Antibody II, Part Number: A32898 The Access Thyroglobulin Antibody... | Siemens Healthcare Diagnostics Inc. | JNL | ||
| Z-1649-2011 | TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated... | Accuray Incorporated | MUJ | ||
| Z-3273-2011 | Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side... | Synthes GmbH | FMF | ||
| Z-1370-2011 | MitraXs" Self Adjusting Atrial Retractor, Sterile EO, Models (REF): A0030/1; A0031/1... | Abbott Medical | DWS | ||
| Z-2703-2011 | "***LINVATEC SRS SHOULDER RESTORATION SYSTEM CrossFT 5.5mm CrossFT Suture Anchor with... | Linvatec Corporation | MBI | ||
| Z-1391-2011 | Haemonetics cardioPAT Cardiovascular - autotransfusion System Catalog Number: 02050-US | Haemonetics Corporation | CAC | ||
| Z-1892-2011 | Universal F Anesthesia Breathing Circuit, REF 5U345-611XB, Manufacturer: King Systems... | King Systems Corporation. | BYG | ||
| Z-1891-2011 | Universal F2 Anesthesia Breathing Circuit, REF 5D440-61X-17, Manufacturer: King... | King Systems Corporation. | BYG | ||
| Z-1890-2011 | Aerosol mask with 15 mm adapter, REF S-MD127, Manufacturer: King Systems, Nobleville... | King Systems Corporation. | BYG | ||
| Z-1889-2011 | Aerosol Mask with 15 mm Adapter, REF MD127, Manufacturer: King Systems, Nobleville... | King Systems Corporation. | BYG | ||
| Z-1888-2011 | Face Tent with 15 mm Adapter, REF S-MD126, Manufacturer: King Systems Nobleville, IN... | King Systems Corporation. | BYG | ||
| Z-1887-2011 | Face Tent with 15 mm Adapter, REF MD126, Manufacturer: King Systems Nobleville, IN... | King Systems Corporation. | BYG | ||
| Z-1456-2011 | Curlin Infusion Administration Set, REF 340-4176, Sterile EO, Zevex, Inc., 4314 Zevex... | Zevex, Inc. | FRN | ||
| Z-1455-2011 | Curlin Infusion Administration Set, REF 340-4169, Sterile EO, Zevex, Inc., 4314 Zevex... | Zevex, Inc. | FRN | ||
| Z-1454-2011 | Curlin Infusion Administration Set, REF 340-4168, Sterile EO, Zevex, Inc., 4314 Zevex... | Zevex, Inc. | FRN | ||
| Z-1453-2011 | Curlin Infusion Administration Set, REF 340-4167, Sterile EO, Zevex, Inc., 4314 Zevex... | Zevex, Inc. | FRN | ||
| Z-1452-2011 | Curlin Infusion Administration Set, REF 340-4164, Sterile EO, Zevex, Inc., 4314 Zevex... | Zevex, Inc. | FRN | ||
| Z-1451-2011 | Curlin Infusion Administration Set, REF 340-4162, Sterile EO, Zevex, Inc., 4314 Zevex... | Zevex, Inc. | FRN | ||
| Z-1450-2011 | Curlin Infusion Administration Set, REF 340-4144, Sterile EO, Zevex, Inc., 4314 Zevex... | Zevex, Inc. | FRN | ||
| Z-1449-2011 | Curlin Infusion Administration Set, REF 340-4137, Sterile EO, Zevex, Inc., 4314 Zevex... | Zevex, Inc. | FRN | ||
| Z-1448-2011 | Curlin Infusion Administration Set, REF 340-4134, Sterile EO, Zevex, Inc., 4314 Zevex... | Zevex, Inc. | FRN | ||
| Z-1447-2011 | Curlin Infusion Administration Set, REF 340-4130-V, Sterile EO, Zevex, Inc., 4314 Zevex... | Zevex, Inc. | FRN | ||
| Z-1446-2011 | Curlin Infusion Administration Set, REF 340-4130, Sterile EO, Zevex, Inc., 4314 Zevex... | Zevex, Inc. | FRN | ||
| Z-1445-2011 | Curlin Infusion Administration Set, REF 340-4128-V, Sterile EO, Zevex, Inc., 4314 Zevex... | Zevex, Inc. | FRN |