---
title: "Tandem pumps are battery-operated infusion pumps capable of both basal and bo... — FDA record Z-1636-2026 | Is It on Recall"
description: "The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infus"
url: https://isitonrecall.com/recall/fda-device-z-1636-2026-tandem-pumps-are-battery-operated-infusion-pumps-capable-of-both-basal-and-bolus-delivery-of-insulin/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utili... — FDA record Z-1636-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jan 30, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: 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).
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: Tandem Diabetes Care, Inc.
- **Quantity**: 1,380 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1636-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1636-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Version 7.8.1/ UDI: (01)008500066132625 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

International distribution in the countries of Czech Republic, Slovakia.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Apr 1, 2026
- **Recall initiation date**: Jan 30, 2026
- **Center classification date**: Mar 25, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1636-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Tandem Diabetes Care Inc records](https://isitonrecall.com/brand/tandem-diabetes-care-inc/)