Home › Device types › LZG
Pump, Infusion, Insulin
FDA product code LZG · Class 2 · General Hospital
96
Registered devices
539,076
Adverse events
126
Recalls
84
510(k) clearances
Devices with this code
ACCU-CHEK AVIVA COMBO — Roche Diagnostics Operations, Inc.V-Go Disposable Insulin Delivery — MANNKIND CORPORATIONt:flex Cartridge, t:lock, 10 Pack — Tandem Diabetes Care, Inc.Accu-Chek Spirit Cartridge — Roche Diabetes Care GmbHDANA Diabecare — SOOIL DEVELOPMENT CO.,LTDSuperline — SOOIL DEVELOPMENT CO.,LTDOmnipod Go Insulin Delivery Device 35U/day — Insulet CorporationOmnipod Go Insulin Delivery Device 20U/day — Insulet CorporationV-Go Disposable Insulin Delivery — MANNKIND CORPORATIONAccu-Chek Combo — Roche Diabetes Care GmbHOneTouch Ping — ANIMAS CORPORATIONOneTouch Ping — ANIMAS CORPORATIONParadigm® REAL-Time Revel™ — MEDTRONIC MINIMED, INC.Paradigm® REAL-Time Revel™ — MEDTRONIC MINIMED, INC.t:slim Insulin Pump, Reconditioned — Tandem Diabetes Care, Inc.t:slim Cartridge, t:lock, 2 Pack — Tandem Diabetes Care, Inc.Superline — SOOIL DEVELOPMENT CO.,LTDCeQur Simplicity — CEQUR CORPORATIONt:slim Insulin Pump, Reconditioned Replacement — Tandem Diabetes Care, Inc.Easy Release — SOOIL DEVELOPMENT CO.,LTDt:slim Cartridge, t:lock, 10 Pack — Tandem Diabetes Care, Inc.t:flex Cartridge, t:lock, 2 Pack — Tandem Diabetes Care, Inc.Easy Release — SOOIL DEVELOPMENT CO.,LTDMODD1 Infusion Set, 10 Pack — Modular Medical, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-20 | Insulet Corporation | External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or b |
| 2026-05-20 | Insulet Corporation | External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or b |
| 2026-02-13 | Medtronic 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 |
| 2025-01-31 | Medtronic 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 |
| 2022-10-17 | Insulet Corporation | The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire haza |
| 2021-07-28 | Roche Diabetes Care, Inc. | Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and |
| 2021-02-01 | Insulet Corporation | Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia. Only Outside the US (OUS): Error in the Omnipo |
| 2020-04-02 | Insulet Corporation | After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the co |
| 2020-04-02 | Insulet Corporation | After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the co |
| 2020-02-13 | Insulet Corporation | In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user |
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