FDA Device Intelligence
HomeDevice types › OZP

Automated Insulin Dosing Device System, Single Hormonal Control

FDA product code OZP · Class 3 · Unknown

148
Registered devices
885,728
Adverse events
23
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-07-13Medtronic MiniMed, Inc.Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result i
2026-02-13Medtronic MiniMed, Inc.All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insul
2026-02-13Medtronic MiniMed, Inc.All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insul
2025-11-02Medtronic MiniMed, Inc.A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspensi
2025-01-31Medtronic MiniMed, Inc.All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to ch
2025-01-31Medtronic MiniMed, Inc.All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to ch
2025-01-31Medtronic MiniMed, Inc.All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to ch
2025-01-31Medtronic MiniMed, Inc.All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to ch
2024-07-31Medtronic MiniMed, Inc.Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump bat
2023-11-15Medtronic MiniMed, Inc.Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 m). A non-conforming GOX layer thickness could impact sensor

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.