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FreeStyle Precision NeoRecalls & reported problems across all models

Abbott Diabetes Care Inc · 5 models in the FDA device registry

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
280
Deaths reported
0
Injuries reported
6
Recalls
0

We found 5 models of FreeStyle Precision Neo by Abbott Diabetes Care Inc in the FDA's device registry (GUDID). Together they are named in 280 adverse event reports in the FDA's MAUDE database, received between Dec 28, 2016 and Apr 9, 2026 — classified as 6 injuries, 274 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (253 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Nov 2023: 7 reportsDec 2023: 3 reportsJan 2024: 6 reportsFeb 2024: 2 reportsMar 2024: 5 reportsApr 2024: 6 reportsMay 2024: 3 reportsJun 2024: 2 reportsJul 2024: 4 reportsAug 2024: 1 reportsSep 2024: 2 reportsOct 2024: 3 reportsNov 2024: 1 reportsDec 2024: 1 reportsJan 2025: 6 reportsFeb 2025: 8 reportsMar 2025: 2 reportsApr 2025: 4 reportsMay 2025: 2 reportsJun 2025: 1 reportsJul 2025: 5 reportsAug 2025: 4 reportsSep 2025: 1 reportsOct 2025: 2 reportsNov 2025: 4 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 2 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520268
Last 36 months. The most recent month may be incomplete.

Most reported FreeStyle Precision Neo problems

Device problems

  • Failure to Power Up253
  • Incorrect, Inadequate or Imprecise Result or Readings22
  • Low Readings3
  • Device Displays Incorrect Message2
  • Unable to Obtain Readings2

Patient problems

  • No Clinical Signs, Symptoms or Conditions188
  • No Known Impact Or Consequence To Patient84
  • Loss of consciousness4
  • Convulsion/Seizure2
  • Dizziness2
  • Hyperglycemia2
  • Hypoglycemia2
  • Fatigue1

FreeStyle Precision Neo models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent FreeStyle Precision Neo adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Abbott Diabetes Care Inc products

All Abbott Diabetes Care Inc devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page