Key facts
| Recalling firm | Beta Bionics, Inc. |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software |
| Classification | Class II |
| Recall number | Z-1809-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery. |
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software -- and the recall number Z-1809-2026. If it matches, stop using or distributing it and contact Beta Bionics, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Beta Bionics, Inc. and the affected product is described in FDA's record as: iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software. FDA's stated reason for the recall is: it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-1809-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
Beta Bionics, Inc.’s FDA history
Argus HQ has recorded 3 total FDA actions tied to Beta Bionics, Inc.: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- How serious is this recall?
- FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
- What should someone who has this product do?
- Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software) and recall number Z-1809-2026, then follow Beta Bionics, Inc.'s recall instructions.
- Has Beta Bionics, Inc. had other FDA recalls or enforcement actions?
- Yes. Argus HQ has recorded 3 total FDA actions tied to Beta Bionics, Inc., including 3 recalls and 0 warning letters.
- What is the FDA recall number for this event?
- FDA recall number Z-1809-2026.
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Related enforcement actions
Full FDA history for Beta Bionics, Inc.Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Class II Recall: iLet Ace Pump Kit REF: BB1001 iLet Dosing… by Beta Bionics, Inc. — Recall Details. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-beta-bionics-inc-z-1809-2026
"FDA Class II Recall: iLet Ace Pump Kit REF: BB1001 iLet Dosing… by Beta Bionics, Inc. — Recall Details." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-beta-bionics-inc-z-1809-2026.
Argus HQ Research. "FDA Class II Recall: iLet Ace Pump Kit REF: BB1001 iLet Dosing… by Beta Bionics, Inc. — Recall Details." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-beta-bionics-inc-z-1809-2026.
@misc{argushq_argushq_ai_recall_fda_recall_beta_bionics_inc_z_1809_2026_2026,
title = {FDA Class II Recall: iLet Ace Pump Kit REF: BB1001 iLet Dosing… by Beta Bionics, Inc. — Recall Details},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/recall/fda-recall-beta-bionics-inc-z-1809-2026},
note = {Accessed: July 13, 2026}
}Source: FDA.gov — Recalls ↗