Autosoft 90 — Class II medical device recall Z-1810-2022
Terminated recall by Unomedical A/S, reported 2022-10-05, distributed in CA. The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insul
| Recall number | Z-1810-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Unomedical A/S, LEJRE, N/A, Denmark |
| Recall initiated | 2022-07-21 |
| Classified | 2022-09-26 |
| Reported by FDA | 2022-10-05 |
| Terminated | 2026-05-04 |
| Distributed | CA |
| Quantity | 1,643,320 units |
| UPC / GTIN / UDI-DI | 05705244018129 |
| Lot numbers | 5372743, 5372744, 5372745, 5372756, 5372758, 5372759, 5372762, 5376469, 5381082, 5381083, 5381084, 5381085, 5381086, 5381087, 5381088, 5381089, 5381090, 5381091, 5381092, 5381093, 5381094, 5381095, 5381096, 5381097, 5381098, 5381099, 5381100, 5381101, 5381102, 5381103, 5381104, 5381105, 5381106, 5381107, 5381108, 5381109, 5381110, 5381111, 5381112, 5381113 and 101 more |
| Model numbers | 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, 1002824 |
Product
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
Reason for recall
The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.
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-1810-2022. 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.