32 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent Model/Catalog Number: 6802344
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code JMO·May 14, 2024
EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
FDA Recall
Open, Classified
·Medtronic Inc.·Product code NIP·July 14, 2022
Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10. Mobile X-ray System.
FDA Recall
Open, Classified
·Olympus Scientific Solutions Americas·Product code RBS·June 9, 2015
Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 7. Impella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L. 8. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 9. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L. 10. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 11. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 12. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 13. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 14. Impella Optical Controller, EU, Loaner; Product Code: 0042-0010-EU-L. 15. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 16. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 17. Impella Optical Controller, UK, Loaner; Product Code: 0042-0010-UK-L. 18. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 19. Impella Optical Controller, US, Loaner; Product Code: 0042-0010-US-L. 20. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 21. Optical AIC w/Impella Connect, Packaged, CA; Product Code: 0042-0040-CA. 22. AIC w/Remote Link, Packaged, Cln Trl, US; Product Code: 0042-0040-CT-L. 23. Optical AIC w/Impella Connect, Packaged, EU; Product Code: 0042-0040-EU. 24. Optical AIC w/Impella Connect, EU, Loaner; Product Code: 0042-0040-EU-L. 25. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP. 26. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP-L. 27. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 28. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US. 29. Optical AIC Impella Connect, US, Loaner; Product Code: 0042-0040-US-L. 30. Dbl optical, AIC Impella Connect, Phg US; Product Code: 1000201. 31. AIC w/Impella Connect for ECP; Product Code: 1000432.
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·June 23, 2025
CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;
FDA Recall
Open, Classified
·Medtronic Heart Valves Division·Product code NPT·June 11, 2021
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
FDA Recall
Open, Classified
·Unomedical A/S Aaholmvej·Product code FPA·July 21, 2022
CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;
FDA Recall
Open, Classified
·Medtronic Heart Valves Division·Product code NPT·June 11, 2021
CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
FDA Recall
Open, Classified
·Medtronic Heart Valves Division·Product code NPT·June 11, 2021
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 7. Impella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L. 8. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 9. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L. 10. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 11. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 12. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 13. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 14. Impella Optical Controller, EU, Loaner; Product Code: 0042-0010-EU-L. 15. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 16. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 17. Impella Optical Controller, UK, Loaner; Product Code: 0042-0010-UK-L. 18. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 19. Impella Optical Controller, US, Loaner; Product Code: 0042-0010-US-L. 20. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. 21. Optical AIC w/Impella Connect,Pack'd, CA; Product Code: 0042-0040-CA. 22. AIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT. 23. AIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT-L. 24. Optical AIC w/Impella Connect,Pack'd, EU; Product Code: 0042-0040-EU. 25. Optical AIC w/Impella Connect,EU,Loaner; Product Code: 0042-0040-EU-L. 26. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP. 27. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP-L. 28. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 29. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US. 30. Optical AIC Impella Connect, US, Loaner; Product Code: 0042-0040-US-L. 31. Dbl optical, AIC Impella Connect, Phg US; Product Code: 1000201. 32. AIC w/Impella Connect for ECP; Product Code: 1000432.
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·October 1, 2025
HeartWare HVAD Pump Implant Kit, REF 1104
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
FDA Recall
Open, Classified
·Aesculap Implant Systems LLC·Product code GWG·July 20, 2023
HeartWare HVAD Implant Kit, REF MCS1705PU
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
HeartWare HVAD Pump Accessories, REF MCS1753AK
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
HeartWare HVAD Outflow Graft, REF MCS1725OG
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
HeartWare HVAD Pump Implant Kit, REF 1103
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
HeartWare HVAD Pump Implant Kit, REF 1153
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
HeartWare HVAD Pump Implant Kit, REF 1125
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
HeartWare HVAD Driveline Extension Cable, REF 100US
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
HeartWare HVAD Implant Kit, REF 1104JP
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
HeartWare HVAD Driveline Extension Cable, REF 100
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021