FDA warns insulin infusion set maker Unomedical over leaks, mishandled complaints

Unomedical, which supplies diabetes tech firms including Medtronic, Tandem Diabetes Care and Beta Bionics, received more than 5,000 complaints about leaking infusion sets between 2023 and 2025.
FierceBiotech

FDA gives Class I recall rating to insulin infusion sets used with Tandem pumps

The tubing used to subcutaneously deliver insulin from a Tandem Diabetes Care pump is among the latest devices to land in the FDA’s hot seat. Unomedical A/S began a recall of some of its VariSoft ...
Yahoo Finance

Unomedical recall of infusion sets tagged as Class I by FDA

The Food and Drug Administration has categorized Unomedical’s recall of VariSoft infusion sets as a Class I event. Unomedical, working with its partner Tandem Diabetes Care, contacted customers last ...
Becker's Hospital Review

130K insulin infusion sets recalled

Unomedical A/S, a maker of single-use medical devices, is pulling about 130,000 insulin infusion products from the market because it might detach mid-infusion, according to the FDA. Nearly 130,700 ...
Business Wire

Tandem Diabetes Care Announces Launch of t:lock Connector for its Insulin Pump Cartridges and Infusion Sets

SAN DIEGO--(BUSINESS WIRE)--Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today announced ...