Manufacturer
6 recalls in our database name Unomedical A/S as the manufacturing or recalling firm.
Of the 6 recalls from Unomedical A/S we have scored against our rubric, 1 (17%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (33%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Unomedical A/S is recalling specific VariSoft Infusion Sets packaged in boxes incorrectly branded as 'Trusteel Infusion Set' instead of 'VariSoft.' No injuries or illnesses have been reported.
Unomedical A/S is recalling 10,770 units of Neria Soft Infusion Sets because certain lots were shipped with incorrect instructions for use. The wrong instruction manual for Rest of World markets was included instead of the FDA-approved US version.
Unomedical recalls 3,362 units of VariSoft infusion sets due to connector damage causing premature disconnection and missed insulin doses, risking dangerous elevation of blood glucose and ketone levels.
The FDA recalls 1,679 VariSoft infusion sets (Model 1002828) due to connector damage that causes improper detachment. Undetected disconnections can lead to missed insulin doses and diabetic ketoacidosis.
Unomedical is recalling 8,028 VariSoft infusion sets due to a manufacturing defect that makes the connector prone to unintended disconnection, potentially leading to missed insulin doses and serious blood glucose complications.
Autosoft 90 insulin infusion sets are recalled because the instructions incorrectly state insulin fill values for two cannula sizes, potentially causing patients to receive fewer insulin units than intended.