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-0888-2010 | Mistique Infusion Catheter, MIC5-135-10-035, Sterile EO, Merit Medical Systems, Inc... | Merit Medical Systems, Inc. | KRA | ||
| Z-0887-2010 | Mistique Infusion Catheter, MIC5-135-10-038, Sterile EO, Merit Medical Systems, Inc... | Merit Medical Systems, Inc. | KRA | ||
| Z-0886-2010 | Mistique Infusion Catheter, MIC5-135-20-035, Sterile EO, Merit Medical Systems, Inc... | Merit Medical Systems, Inc. | KRA | ||
| Z-0885-2010 | Mistique Infusion Catheter, MIC5-135-20-038, Sterile EO, Merit Medical Systems, Inc... | Merit Medical Systems, Inc. | KRA | ||
| Z-0884-2010 | Mistique Infusion Catheter, MIC5-135-5-035, Sterile EO, Merit Medical Systems, Inc... | Merit Medical Systems, Inc. | KRA | ||
| Z-0883-2010 | Mistique Infusion Catheter, MIC5-135-5-038, Sterile EO, Merit Medical Systems, Inc... | Merit Medical Systems, Inc. | KRA | ||
| Z-0882-2010 | Mistique Infusion Catheter, MIC5-45-10-035, Sterile EO, Merit Medical Systems, Inc... | Merit Medical Systems, Inc. | KRA | ||
| Z-0881-2010 | Mistique Infusion Catheter, MIC5-45-10-038, Sterile EO, Merit Medical Systems, Inc... | Merit Medical Systems, Inc. | KRA | ||
| Z-0880-2010 | Mistique Infusion Catheter, MIC5-45-20-035, Sterile EO, Merit Medical Systems, Inc... | Merit Medical Systems, Inc. | KRA | ||
| Z-0879-2010 | Mistique Infusion Catheter, MIC5-45-20-038, Sterile EO, Merit Medical Systems, Inc... | Merit Medical Systems, Inc. | KRA | ||
| Z-0878-2010 | Mistique Infusion Catheter, MIC5-45-5-038, Sterile EO, Merit Medical Systems, Inc., South... | Merit Medical Systems, Inc. | KRA | ||
| Z-0877-2010 | Mistique Infusion Catheter, MIC5-45-5-035, Sterile EO, Merit Medical Systems, Inc., South... | Merit Medical Systems, Inc. | KRA | ||
| Z-0876-2010 | Mistique Infusion Catheter, MIC5-90-10-035, Sterile EO, Merit Medical Systems, Inc... | Merit Medical Systems, Inc. | KRA | ||
| Z-0875-2010 | Mistique Infusion Catheter, MIC5-90-10-038, Sterile EO, Merit Medical Systems, Inc... | Merit Medical Systems, Inc. | KRA | ||
| Z-0874-2010 | Mistique Infusion Catheter, MIC5-90-20-035, Sterile EO, Merit Medical Systems, Inc... | Merit Medical Systems, Inc. | KRA | ||
| Z-0873-2010 | Mistique Infusion Catheter, MIC5-90-20-038, Sterile EO, Merit Medical Systems, Inc... | Merit Medical Systems, Inc. | KRA | ||
| Z-0872-2010 | Mistique Infusion Catheter, MIC5-90-5-035, Sterile EO, Merit Medical Systems, Inc., South... | Merit Medical Systems, Inc. | KRA | ||
| Z-1029-2010 | SS-H2O Aerospray Deionized Water, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321. | ELITechGroup Inc | HYB | ||
| Z-1028-2010 | SS-035CG, Hematology Reagent C Eosin Stain, 1 U.S. Gallon, IVD, Wescor, Inc, Logan, Utah... | ELITechGroup Inc | HYB | ||
| Z-1027-2010 | SS-035C, Hematology Reagent C Eosin Stain, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321... | ELITechGroup Inc | HYB | ||
| Z-0195-2013 | Class II | ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The... | Sendx Medical, Inc. | CHL | |
| Z-1997-2010 | PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems. | Canon Medical Systems USA, Inc. | ITX | ||
| Z-0863-2010 | Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell. PN Numbers: A10405... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1065-2010 | Hill-Rom TotalCare Bed System, Hill-Rom, Batesville, IN; Model P1900 and P1840. The... | Hill-Rom Inc. | FNL | ||
| Z-1398-2010 | SmarTemp Probe Covers for use with the VS-800 Monitor; Rx only, Mindray DS USA, Inc... | Datascope Corp. | DQA | ||
| Z-1397-2010 | SmarTemp Probe Covers for use with the DPM3 Monitor; Rx only, Mindray DS USA, Inc... | Datascope Corp. | DQA | ||
| Z-1396-2010 | SmarTemp Probe Covers with the Accutorr V Monitor; Rx only. Mindray DS USA, Inc... | Datascope Corp. | DXN | ||
| Z-1596-2010 | ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA) for the... | Abbott Diagnostic International, Ltd. | LOL | ||
| Z-0823-2010 | Stryker XIA 3 Polyaxial Screw, 8.5mm x 65 mm. Catalog Number: 482318565. Not... | Howmedica Osteonics Corp | NKB | ||
| Z-1099-2010 | , REF: 084500500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004... | LivaNova USA, Inc. | DWF | ||
| Z-1098-2010 | Smart Perfusion Pack, REF: 084500300, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th... | LivaNova USA, Inc. | DWF | ||
| Z-1097-2010 | Smart Perfusion Pack, REF: 088501900, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th... | LivaNova USA, Inc. | DWF | ||
| Z-1096-2010 | Smart Perfusion Pack, REF: 088504500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th... | LivaNova USA, Inc. | DWF | ||
| Z-1095-2010 | Smart Perfusion Pack, REF: 088503400, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th... | LivaNova USA, Inc. | DWF | ||
| Z-1094-2010 | Smart Perfusion Pack, REF: 088503000, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th... | LivaNova USA, Inc. | DWF | ||
| Z-1093-2010 | Perfusion Pack, REF: 088502800, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way... | LivaNova USA, Inc. | DWF | ||
| Z-1092-2010 | Smart Perfusion Pack, REF: 088502500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th... | LivaNova USA, Inc. | DWF | ||
| Z-1091-2010 | Smart Perfusion Pack, REF: 088502200, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th... | LivaNova USA, Inc. | DWF | ||
| Z-1090-2010 | Smart Perfusion Pack, REF: 088501100, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th... | LivaNova USA, Inc. | DWF | ||
| Z-1089-2010 | Smart Perfusion Pack, REF: 088500900, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th... | LivaNova USA, Inc. | DWF | ||
| Z-1088-2010 | Smart Perfusion Pack, REF: 088500700, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th... | LivaNova USA, Inc. | DWF | ||
| Z-1087-2010 | Smart Perfusion Pack, REF: 086500600, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th... | LivaNova USA, Inc. | DWF | ||
| Z-1086-2010 | Smart Perfusion Pack, REF: 086500301, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th... | LivaNova USA, Inc. | DWF | ||
| Z-1085-2010 | Smart Perfusion Pack, REF: 086500300, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th... | LivaNova USA, Inc. | DWF | ||
| Z-1084-2010 | Opti-Pack Smart Perfusion Pack, REF: 086500100, Sterile EO, Sorin Group USA, Inc., 14401... | LivaNova USA, Inc. | DWF | ||
| Z-1102-2010 | Howmedica Osteonics Corp. Restoration Modular Revision Hip System, Plasma Distal Stem... | Howmedica Osteonics Corp | LZO | ||
| Z-1008-2011 | CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery... | Accuray Incorporated | MUJ | ||
| Z-1623-2011 | CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000 Automated... | Abbott Medical | GKZ | ||
| Z-0846-2010 | Stryker T2 Ankle Arthrodesis Nail, right; 012 x 300 mm; Catalog number... | Howmedica Osteonics Corp | HSB | ||
| Z-0845-2010 | Stryker T2 Ankle Arthrodesis Nail, right; 011 x 300 mm; Catalog number: 18191130S... | Howmedica Osteonics Corp | HSB |