Class II recallOngoing

Tandem pumps recall — FDA event 98478

FDA · FDA event 98478 · Posted Mar 25, 2026

Published Mar 25, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

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.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

On January 30, 2026, Tandem Diabetes Care issued a Urgent Medical Device Recall Notice to affected consignees via E-Mail. Tandem ask consignees to take the following actions:
1. Discard your existing User Guide. 2. Refer to the corrected User Guide version 7.8.1 which is available online at www.tandemdiabetes.com/cs-cz/support/resources/documents for accurate instructions on using your t:slim X2 Insulin Pump. 3. Physical copies of the corrected User Guide are being produced to replace the incorrect versions. If you would like a physical copy of the corrected User Guide, you may contact A. Import s customer service line to arrange for a replacement. 4.As requested above, please complete the online form acknowledging receipt of this notice. 5. Should you experience any device-related serious incidents, please report them to your distributor, a local contact point, or the State Institute for Drug Control.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Tandem pumps by Tandem Diabetes Care, Inc..

Products affected by FDA event 98478
Model	Description	Lot / serial range	Manufactured	Status
Z-1636-2026	Z-1636-2026	Version 7.8.1/ UDI: (01)008500066132625	Not provided in the normalized record	Ongoing

Distribution: International distribution in the countries of Czech Republic, Slovakia.
Units affected: See official FDA record
Category: Insulin pumps

Timeline

Jan 30, 2026
Recall initiated
Date recorded by the FDA.
Mar 25, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 98478
Published: Mar 25, 2026
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

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Tandem pumps recall — FDA event 98478

FDA · FDA event 98478 · Posted Mar 25, 2026

Published Mar 25, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

Products affected by FDA event 98478
Model	Description	Lot / serial range	Manufactured	Status
Z-1636-2026	Z-1636-2026	Version 7.8.1/ UDI: (01)008500066132625	Not provided in the normalized record	Ongoing

Distribution

International distribution in the countries of Czech Republic, Slovakia.

Units affected

See official FDA record

Tandem pumps recall — FDA event 98478

Follow Tandem pumps

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Tandem pumps recall — FDA event 98478

Follow Tandem pumps

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline