tandem diabetes care, inc.medicalHigh PriorityActive

Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).

Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). was recalled because 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.. If you have this product, stop using it until you verify your lot or model details.

By RecallRadar Editorial Team

Sourced from FDA. Last verified April 8, 2026.

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Key facts

Date announced: April 1, 2026
Source agency: FDA

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

What's Being Recalled

Quoted source excerpt from the official notice.

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.

Quick Info

Key facts from the official notice, kept in the article flow for easy cross-checking.

Brand: Tandem diabetes care, inc.
Category: medical
Source agency: FDA
Announced: April 1, 2026
Country: US
Status: Active

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

Version 7.8.1/ UDI: (01)008500066132625

#	Model
1	Version 7.8.1/ UDI: (01)008500066132625

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

What You Should Do

Follow the remedy path from the official notice using the exact model and serial details above.

1Stop using the affected product until you verify whether your item is impacted.
2Check the official recall notice and match your model, lot, or serial details.
3Follow the official instructions for repair, replacement, refund, or disposal.

Open Official Recall Notice

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source: FDA
Announced by source: April 1, 2026
Last reviewed by RecallRadar: April 8, 2026

Frequently Asked Questions

Am I affected by this recall?

Check the affected models section on this page. The official notice currently lists Version 7.8.1/ UDI: (01)008500066132625.

What is the remedy for this recall?

Follow the official instructions for repair, replacement, refund, or disposal on the tandem diabetes care, inc. recall page.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://api.fda.gov/device/enforcement.json?search=recall_number:Z-1636-2026&limit=1

Keep browsing with these internal hubs: tandem diabetes care, inc. recall hub and Medical recall hub.