Unomedical A/S
Unomedical A/S has 4 FDA enforcement events on this register (6 product records) between 2022 and 2024: 4 device; the busiest year was 2024 with 2.
25% of its events are Class I; the most common class is Class II (3). 3 events are listed as ongoing; the recalling firm's address is in N/A.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 23 Jul 2024 | VariSoft Infusion Set, Single Use. | Device | Class II | 1 | Ongoing |
| 5 Mar 2024 | Neria Soft Infusion Set, Product Code 507302, intravascular administration set | Device | Class II | 1 | Ongoing |
| 11 Oct 2023 | VariSoft infusion set, Model Number 1002827 | Device | Class I | 3 | Ongoing |
| 21 Jul 2022 | Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump. | Device | Class II | 1 | Terminated |
By type and class
Class I: 25% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Unomedical A/S had?
4 enforcement events (6 product records) on this register, 2022–2024: 4 device.
Are any Unomedical A/S recalls ongoing?
3 events are listed as ongoing in the current openFDA export.
What class are Unomedical A/S recalls?
3 Class II, 1 Class I. 25% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.