FreeStyle Precision H Blood Glucose and Ketone Monitoring System — Class II medical device recall Z-1558-2020
Terminated recall by Abbott Diabetes Care, Inc., reported 2020-04-01, distributed in AL, CA, CT, DC, FL, GA, ID, IL…. Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters w
| Recall number | Z-1558-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Diabetes Care, Inc., Alameda, CA, United States |
| Recall initiated | 2019-11-14 |
| Classified | 2020-03-23 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2021-04-28 |
| Distributed | AL, CA, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, ME, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 00093815711810 |
Product
FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
Reason for recall
Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to inappropriate meter disinfection or improper handling of contaminated meters, which may cause infection or exacerbation of an existing infection.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1558-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.