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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98478

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 30, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Tandem Diabetes Care, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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).

Z-1636-2026
Recall number
Z-1636-2026
Initiated
January 30, 2026
Classification
Class II
Status
Ongoing
Quantity
1,380 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

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Inspect official wording and provenance

Reason for recall

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.

Code information

Version 7.8.1/ UDI: (01)008500066132625

Distribution pattern

International distribution in the countries of Czech Republic, Slovakia.