FDA recall record · openFDA

Unomedical A/S

5 FDA recalls on record (2023–2024) — 5 device. 5 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connec 3

Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorr 1

Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion S 1

Recalls

VariSoft infusion set, Model Number 1002828 Class I 2023-10-11 VariSoft infusion set, Model Number 1002827 Class I 2023-10-11 VariSoft infusion set, Model Number 1002830 Class I 2023-10-11 Neria Soft Infusion Set, Product Code 507302, intravascular administration set Class II 2024-03-05 VariSoft Infusion Set, Single Use. Class II 2024-07-23

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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