Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Autosoft 90 Recalled by Unomedical A/S Due to The IFU incorrectly states the insulin fill value...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Unomedical A/S directly.
Affected Products
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
Quantity: 1,643,320 units
Why Was This Recalled?
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.
Where Was This Sold?
Distribution was made to California. There was no government/military distribution.
About Unomedical A/S
Unomedical A/S has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report