Quick Facts at a Glance
- Recall Date
- January 30, 2026
- Hazard Level
- HIGH
- Brand
- Tandem Diabetes Care
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL, PREGNANT, CHILDREN
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Tandem Diabetes Care
- Product type
- Insulin Infusion Pump
- Model numbers
- Version 7.8.1/ UDI: (01)008500066132625
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 30, 2026
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Tandem Diabetes Care, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
Tandem insulin infusion pumps deliver basal and bolus doses of insulin via a disposable cartridge. The device uses a motor-driven mechanism and is programmable by the user to manage insulin delivery.
Why This Is Dangerous
A translation error in the Czech user guide could cause unintended insulin delivery by instructing users to verify the infusion set is connected to the body, when it should be confirmed as not connected. This could lead to hypoglycemia.
Industry Context
This recall is not indicated as part of a broader industry pattern.
Real-World Impact
The recall highlights the risk of user-facing documentation causing incorrect device operation. Consumers should stop using affected pumps and await manufacturer guidance to avoid hypoglycemia.
Practical Guidance
How to identify if yours is affected
- Check model version and UDI on device label.
- Review the Czech user guide for translation accuracy related to infusion-set connection.
Where to find product info
On device label, packaging, recall letter, or the manufacturer’s website
What timeline to expect
Timelines vary; expect 4-8 weeks for remedy processing in typical cases
If the manufacturer is unresponsive
- Document all communications with the manufacturer
- Escalate to the regulator if the company is unresponsive
- Consult healthcare providers for interim insulin management
How to prevent similar issues
- Verify manuals before use and ensure the language matches your reading comprehension
- Request updated instructions if you operate in a non-native language region
- Keep a copy of recall communications and model numbers
Documentation advice
Keep the recall notification, purchase receipts, model numbers, and all correspondence with the manufacturer
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Product Details
Model: Version 7.8.1 / UDI: (01)008500066132625 Sold internationally in the Czech Republic and Slovakia Recall date: 2026-01-30 Reported date: 2026-04-01 Price: Unknown Quantity: 1,380 units
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Countries affected: Czech Republic, Slovakia
- Hazard: unintended insulin delivery and potential hypoglycemia
- No injuries reported
- Recall status: ACTIVE
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