VariSoft infusion set — Class I medical device recall Z-0234-2024
Ongoing recall by Unomedical A/S, reported 2023-11-29, distributed nationwide. The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to
| Recall number | Z-0234-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Unomedical A/S, LEJRE, N/A, Denmark |
| Recall initiated | 2023-10-11 |
| Classified | 2023-11-20 |
| Reported by FDA | 2023-11-29 |
| Distributed | Nationwide (US) |
| Quantity | 3,362 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 05705244018785, 05705244018792 |
| Serial numbers | 5388368 |
| Model numbers | 1002830 |
Product
VariSoft infusion set, Model Number 1002830
Reason for recall
The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0234-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.