Use cautionMedical device recall · FDA · Published January 30, 2026
Tand: Pumps with Czech guide errors may cause insulin delivery errors
Tandem Diabetes Care recalls pumps with Czech language user guide errors that could lead to unintended insulin delivery and hypoglycemia. Affected pumps have version 7.8.1 and UDI (01)008500066132625.
The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.
Take action
Contact the company
📍Recalling firmTandem Diabetes Care, Inc.12400 High Bluff Dr · San Diego, CA 92130-3077
✎ GovInfoNow plain-language explainer
Tandem Diabetes Care is recalling insulin pumps that have a Czech language user guide with translation errors. These errors could cause users to mistakenly think the infusion set is connected when it's not, leading to unintended insulin delivery and potentially dangerous low blood sugar events. Read more at govinfonow.com/recall/50067-tand-pumps-with-czech-guide-errors-may-cause-insulin-delivery.
“Tand: Pumps with Czech guide errors may cause insulin delivery errors.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/50067-tand-pumps-with-czech-guide-errors-may-cause-insulin-delivery. Based on FDA recall #Z-1636-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1636-2026%22&limit=1).
The FDA announced on Jan. 30, 2026, that Tandem Diabetes Care, Inc. is recalling battery-operated insulin infusion pumps distributed in the Czech Republic and Slovakia because a Czech language user guide contains translation errors. The agency stated the error could lead to unintended insulin delivery.
How to tell if you have it
Brand: Tandem
Product: Tandem pumps (battery-operated infusion pumps)
Software Version: 7.8.1
UDI: (01)008500066132625
Quantity: 1,380 units
Distribution: Czech Republic, Slovakia
The hazard
The recall cites a hazard where the Czech language user guide incorrectly instructs users to verify that the infusion set is connected to the body, rather than confirming it is not connected. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.
Context
GovInfoNow's records show Tandem Diabetes Care, Inc. has had nine other recalls on record since April 23, 2018. Recent similar recalls include the Tandem Mobi Insulin Pump recall for false vibration motor failure risk (Oct. 6, 2025), the Tandem t:slim X2 and Mobi insulin pumps with G7 sensor risk hypoglycemia (Aug. 5, 2025), and a recall regarding insulin pumps manufactured with speakers from Revision A and B (July 21, 2025). Other recent recalls of similar products include the Medtronic MiniMed 630G Insulin Pump Recall for risk of insulin delivery errors (Feb. 13, 2026), the Medtronic MiniMed 780G Insulin Pump Recall for software error causing insulin stoppage (May 27, 2026), and the Medtronic MiniMed 780G Insulin Pump Recall for risk of incorrect insulin delivery (July 13, 2026).
How to tell if you have this one
Check for the version number 7.8.1 on the pump's software. The unique device identifier (UDI) is (01)008500066132625. These pumps were sold with the Czech language guide.
Brand
Tandem
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check User Guide Version
Look for version 7.8.1 on the pump's software or user guide.
Contact Tandem Support
Reach out to Tandem Diabetes Care for guidance on next steps.
How this recall unfolded
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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.
Official source: FDA Recall #Z-1636-2026 (January 30, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1636-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.