Food, drugs, devices › Unomedical A/S
Device recall: Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion
FDA enforcement event 90719 is a device recall by Unomedical A/S of LEJRE, N/A, initiated 21 Jul 2022 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 4 May 2026. Initiation: voluntary: firm initiated. Unomedical A/S has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Unomedical A/S, LEJRE, N/A, Denmark.
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."
Distribution
"Distribution was made to California. There was no government/military distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1810-2022 | Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump. | 1,643,320 units | Class II | Terminated | 5 Oct 2022 |
Context
Other enforcement events for Unomedical A/S
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Jul 2024 | VariSoft Infusion Set, Single Use. | Device | Class II | 1 |
| 5 Mar 2024 | Neria Soft Infusion Set, Product Code 507302, intravascular administration set | Device | Class II | 1 |
| 11 Oct 2023 | VariSoft infusion set, Model Number 1002827 | Device | Class I | 3 |
All 4 events for Unomedical A/S
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distribution was made to California. There was no government/military distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 May 2026. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.