Recall Z-0316-2027 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Tandem Diabetes Care, Inc.
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
| Date | Oct 30, 2026 (initiated Sep 23, 2026) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Process change control |
| Action | On 9/23/2026, "URGENT MEDICAL DEVICE CORRECTION" recall and correction notices were emailed to customers who were asked to do the following: Correction notices: Continue to use pump while following the instructions below. 1) Always respond to an occlusion alarm and follow the recommended troubleshooting steps in the User Guide. Acknowledge the alarm, inspect the cartridge, tubing, and infusion site for signs of damage or blockage, correct any identified condition, and resume insulin delivery. 2)Ensure that your Tandem Mobi mobile app has push notifications enabled so if the alarm does occur, |
| Quantity | 80,938 (77,559 US, 3,379 OUS) |
| Distribution | 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 Ca |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223213 | Tandem Mobi Insulin Pump with Interoperable Technology Tandem Diabetes Care, Inc., Jul 10, 2023 |
| K233044 | Tandem Mobi insulin pump with interoperable technology Tandem Diabetes Care, Inc., Oct 5, 2023 |
| K240309 | Tandem Mobi insulin pump with interoperable technology Tandem Diabetes Care, Inc., Mar 21, 2024 |
| K241078 | Tandem Mobi Insulin Pump with interoperable technology Tandem Diabetes Care, Inc., Jul 26, 2024 |
| K253074 | Tandem Mobi insulin pump with interoperable technology Tandem Diabetes Care, Inc., Nov 6, 2025 |