In the agency's Nov 11, 2026 enforcement report · Ongoing
Tandem Mobi Insulin Pump, Models: 1004004, 1010750, 1012676, 1012719, 1013655, 1013656, 1013501, 1013700, 1014081,…
Tandem Diabetes Care, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tandem Diabetes Care, Inc. · 12400 High Bluff Dr · San Diego, CA · 92130-3077
Is this the product you have?
- Tandem Mobi Insulin Pump
- Models
10040041010750101267610127191013655101365610135011013700101408110148011014811101481310149361016911101691210169131016914101807510180771018078
- Lot codes and dates
- UDI-DIAll affected pump models and serial numbers may be affected. Pump serial numbers with frequent false-positive
003891520750130038915227191000389152350110003891523655100038915236561900389152370019003891524801140038915248111100389152481319.
- occlusion alarms to be exchanged
4,605 of 4,605 codes
119859911991441201048120177712021071202156120450012049351207112120940512098621211585121814312201211220201122047012204711221343122134712217751221783122211112233461223487122348812238861223906122394012243631224978122501712250241225158122517112251941225204122558912256021225682122635912263601226365122667112267211226748122685912269891227008122702112272271227375122744212293001229807122996912300641231839123332612335151233517
- UDI-DI
- Amount recalled
- 80,938 (77,559 US, 3,379 OUS)
Where it was sold
Why it was recalled
Stop using this product now
Tandem Diabetes Care, Inc. ( Tandem ) has identified that certain Tandem Mobi insulin pumps may generate false-positive occlusion alarms when no actual insulin flow obstruction is present. Investigation determined that increased friction within the drive module can reduce available motor power and, under certain conditions, cause motor speed to fall below the occlusion detection threshold. As a result, the pump may incorrectly detect an occlusion condition and suspend insulin delivery. When an occlusion alarm occurs, insulin delivery remains suspended until the user acknowledges the alarm and resumes therapy. Repeated false-positive occlusion alarms, if not addressed promptly, may result in interruptions of insulin delivery that can increase the risk of elevated blood glucose levels. In severe cases, hyperglycemia may require medical intervention or hospitalization.
Using this product could cause serious injury, illness or death — stop using it now.
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