iLet Bionic Pancreas recall — FDA event 98517

What happened

The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock Screen, no screen transition occurs, and the user remains on the Lock Screen. Because the user cannot exit the Lock Screen, the user is unable to perform a cartridge change or meal announcement. If this occurs and therapy is in progress, therapy will continue normally until the insulin cartridge is depleted. The user will be unable to perform a cartridge change or a meal announcement and will be stuck on the screen until the battery fully drains. This can lead to hyperglycemia.

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 to do

Affected products and models

Distribution

US: WI, HI, OH, ME, CO, NJ, NE, KY, SC, CA, TX, NH, NY, WA, PA, MD, FL, IA, GA, MI, VT, TN, IL, IN, KS, MA, LA, MS, NC, CT, MN, VA, OK, AR, AZ, MO, MT, RI, DC, NM, OR, ID, NV, AK, ND, DE, WV, WY, SD, UT, AL

Units affected

See official FDA record

Category

Insulin pumps

Timeline

1. Sep 23, 2025

   Recall initiated

   Date recorded by the FDA.

2. Jun 18, 2026

   Posted by FDA

   The recall event appeared in the FDA source.

3. Oct 8, 2026

   Last checked

   MedWatcher last reconciled this record with the openFDA export.