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.
The company is a legitimate manufacturer of medical devices for diabetes management. There is no indication of harmful activity or fraud.
People with diabetes
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.
Yes, Tandem Diabetes Care, Inc. is a legitimate company that manufactures insulin pumps and diabetes management solutions. They are a leading provider in the diabetes care industry.
Tandem Diabetes Care, Inc. manufactures insulin pumps, continuous glucose monitors (CGMs), and diabetes management software solutions.
Ensure that the products have proper medical device certifications and regulatory approvals (e.g., FDA) before use.
We’ve drafted a message you can send Tandem Diabetes Care, Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-2343-2025 — Tandem Diabetes Care, Inc. Tandem Diabetes Care, Inc. Hello, I own a Tandem Diabetes Care, Inc. that is covered by recall Z-2343-2025 from Tandem Diabetes Care, Inc.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
