FreeStyle 70469Recalls & reported problems
Abbott Diabetes Care Inc · FreeStyle Lancets 28 Gauge · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Mar 16, 2021Open, Classified
Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Z-1929-2021 · Root cause: Environmental control · FDA record ↗
Other Single use only blood lancet without an integral sharps injury prevention feature devices
- Accu-Chek Softclix 05181186001Roche Diabetes Care GmbH · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature133 reports
- OneTouch Delica Plus Lancet 02400801Asahi Polyslider Company,Limited · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature1 recall0 reports
- OneTouch Delica Plus Lancet 02401101Asahi Polyslider Company,Limited · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature1 recall0 reports
- Accu-Chek Softclix 11893238160Roche Diabetes Care GmbH · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature8 reports
- Accu-Chek Softclix 05509661001Roche Diabetes Care GmbH · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature5 reports
- TRUEplus TRUEplus Sterile LancetsTrividia Health, Inc. · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature4 reports
- Accu-Chek Softclix 03144844001Roche Diabetes Care GmbH · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature2 reports
- TRUEplus TRUEplus Sterile LancetsTrividia Health, Inc. · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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