Tandem Diabetes Care, Inc. is a leading manufacturer of insulin pumps and diabetes management solutions. They provide innovative technology to help people with diabetes manage their condition effectively.
Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization.
Tandem Diabetes Care, Inc. is a company that manufactures insulin pumps and diabetes management solutions. They focus on providing innovative technology to help individuals with diabetes manage their condition effectively. Read more at govinfonow.com/recall/51763-tandem-diabetes-care-inc-manufacturer-of-insulin-pumps-and-diabetes.
Source Summary by GovInfoNow · govinfonow.com/recall/51763-tandem-diabetes-care-inc-manufacturer-of-insulin-pumps-and-diabetes · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2343-2025
“Tandem Diabetes Care, Inc. - Manufacturer of Insulin Pumps and Diabetes Management.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51763-tandem-diabetes-care-inc-manufacturer-of-insulin-pumps-and-diabetes. Based on FDA recall #Z-2343-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2343-2025%22&limit=1).
The U.S. Food and Drug Administration (FDA) has recorded a Class I voluntary recall initiated by Tandem Diabetes Care, Inc.
A software issue in the beta version of the iOS application prevented successful pairing with Abbott FreeStyle Libre 3 Plus (FSL3P).
The recall was filed on 2026-07-16. Tandem Diabetes Care, Inc. has 10 other recalls on record since 2018-04-23.
Check for proper medical device certifications and regulatory approvals (e.g., FDA) for insulin pumps and diabetes management solutions.
Ensure that Tandem Diabetes Care, Inc. is a legitimate company by checking their official website and regulatory approvals (e.g., FDA).
Look for detailed product information on insulin pumps and diabetes management solutions to ensure they meet medical standards.
Discuss any concerns with your healthcare provider or diabetes educator to ensure the device is appropriate for your needs.
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution. US nationwide including Puerto Rico, Canada, Czech Republic, Slovakia, Spain, United Kingdom, Belgium, Luxembourg, Australia, France, Italy, New Zealand, Finland, Sweden, Denmark, Norway, Saudi Arabia, Germany,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 44 days after the firm started it.
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.