CLASS II Device recall · Reported 1 Apr 2020 · FDA Enforcement Report
FreeStyle Precision H Blood Glucose and Ketone Monitoring System recalled
Abbott Diabetes Care is recalling FreeStyle Precision H Blood Glucose and Ketone Monitoring System, distributed in 32 states. The recall was initiated on 14 Nov 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1558-2020
- FDA event ID
- 84866
- Recalling firm
- Abbott Diabetes Care, Alameda, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Nov 2019
- FDA classified
- 23 Mar 2020
- Reported
- 1 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 14 Nov 2019 | Recall initiated by company | |
| 23 Mar 2020 | Classified by FDA | +130 days |
| 1 Apr 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
Where it was distributed
U.S.: KY, NY, TN, MA, IL, SC, VT, FL, CA, NC, MS, NJ, TX, AL, GA, OK, CT, PA, NE, ND, MT, MO, DC, ME, LA, KS, ID, OH, MN, NM, VA, IN
AlabamaCaliforniaConnecticutDistrict of ColumbiaFloridaGeorgiaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaineMinnesotaMissouriMississippiMontanaNorth CarolinaNorth Dakota
Questions about this recall
Is FreeStyle Precision H Blood Glucose and Ketone Monitoring System recalled?
Yes. Abbott Diabetes Care recalled FreeStyle Precision H Blood Glucose and Ketone Monitoring System on 14 Nov 2019. The recall is Class II and its status is Terminated. Recall number Z-1558-2020.
Why was it recalled?
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.
Which lots are affected?
All lots.
Where was it sold?
U.S.: KY, NY, TN, MA, IL, SC, VT, FL, CA, NC, MS, NJ, TX, AL, GA, OK, CT, PA, NE, ND, MT, MO, DC, ME, LA, KS, ID, OH, MN, NM, VA, IN
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Abbott Diabetes Care
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|---|---|---|---|---|---|
| Device | CLASS II | FreeStyle Libre 3 App, part of Continuous Glucose recalled | Abbott Diabetes Care | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | FreeStyle Libre 2 Readers recalled by Abbott Diabetes Care | Abbott Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS I | FreeStyle Libre Reader recalled by Abbott Diabetes Care | Abbott Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS I | FreeStyle Libre Reader recalled by Abbott Diabetes Care | Abbott Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS I | FreeStyle Libre Reader recalled by Abbott Diabetes Care | Abbott Diabetes Care | Device Malfunction | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 459| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Lead & Heavy Metals | Nationwide |