Unomedical A/S
FDA adverse event reports naming Unomedical A/S as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: UNOMEDICAL A/S.
- Total reports
- 60,487
- Deaths
- 152
- Injuries
- 11,831
- Malfunctions
- 48,504
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Set, Administration, IntravascularFPA60,411
- Non-Invasive Central Venous ManometerPFA34
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ22
- Enteroscope And AccessoriesFDA10
- Pump, Infusion, InsulinLZG4
- Tube, FeedingFPD2
- System, Test, Blood Glucose, Over The CounterNBW2
- Cystometric Gas (Carbon-Dioxide) On Hydraulic DeviceFAP1
- Tubing, Fluid DeliveryFPK1
Recent recalls
- 2024-09-19Open, ClassifiedProcess change control
VariSoft Infusion Set, Single Use.
Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
- 2024-04-15Open, ClassifiedDevice Design
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The difference between the US IFU and the ROW IFU is the addition of an intended use section in the ROW IFU.
- 2023-11-21Open, ClassifiedProcess change control
VariSoft infusion set, Model Number 1002827
The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.
- 2023-11-21Open, ClassifiedProcess change control
VariSoft infusion set, Model Number 1002828
The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.hyperglycemia). Diabetic ketoacidosis.
- 2023-11-21Open, ClassifiedProcess change control
VariSoft infusion set, Model Number 1002830
The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.
- 2022-09-26TerminatedLabeling Change Control
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
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.
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