FDA recall, , High risk
Tandem Diabetes Care Tandem Mobi Insulin Pump
Tandem Mobi insulin pumps may generate false-positive occlusion alarms, suspending insulin delivery and potentially causing elevated blood glucose levels.
Summary by Recall Canary from the FDA notice
What happened
Tandem Diabetes Care, Inc., of San Diego, California, is voluntarily recalling certain Tandem Mobi Insulin Pump, Models: 1004004, 1010750, 1012676, 1012719, 1013655, 1013656, 1013501, 1013700, 1014081, 1014801, 1014811, 1014813, 1014936, 1016911, 1016912, 1016913, 1016914, 1018075, 1018077, 1018078. The recall began September 23, 2026, and covers 80,938 pumps (77,559 US, 3,379 OUS). The FDA added it to the Enforcement Report and classified it on October 30, 2026.
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. Distribution is nationwide in the US and worldwide including Canada.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number and UDI-DI are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Tandem Mobi Insulin Pump
- Model number
- 1004004
- 1010750
- 1012676
- 1012719
- 1013655
- 1013656
- 1013501
- 1013700
- 1014081
- 1014801
- 1014811
- 1014813
- 1014936
- 1016911
- 1016912
- 1016913
- 1016914
- 1018075
- 1018077
- 1018078
- UDI-DI
- 00389152075013
- 00389152271910
- 00389152350110
- 00389152365510
- 00389152365619
- 00389152370019
- 00389152480114
- 00389152481111
- 00389152481319
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
Worldwide - US Nationwide distribution including in the states of CA, FL, NC, OK, UT, WA, IL, PA, MN, VA, NY, IN, HI, OR, GA, MI, KS, CO, WI, SC, null, TX, NE, AZ, OH, NM, NV, MA, SD, IA, TN, ID, MD, RI, CT, NJ, ME, KY, MT, WV, VT, MS, AR, AL, DC, LA, MO, NH, PR, ND, AK, DE, WY and the country of Canada.
- Recalled by
- Tandem Diabetes Care, Inc.San Diego, California
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- FDA event number
- 99851
- Recall number
- Z-0316-2027
- Quantity recalled
- 80,938 (77,559 US, 3,379 OUS)
- Recall type
- Voluntary: Firm initiated
All recalls from Tandem Diabetes Care, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Tandem Diabetes Care began the recall
FDA posted the recall to its Enforcement Report and rated it Class I (high risk)
Added to Recall Canary