FreeStyle Libre 3 Sensor
Medical device recall Z-1020-2026. Published in FDA’s Enforcement Report on Jan 21, 2026.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 21, 2026. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- 36 states named in where it went
- 1,060,723 sensors how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
1,060,723 sensors, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number: 72081-01 UDI-DI Code: 00357599818005 Product with Expiry Date 12/31/2025 Kit Lot Numbers: T60003054 Pack Serial Numbers: 0HYCDDYCC 0HYCDDYC1 0HYCDDY3A 0HYCDDYCE 0HYCDDY32 0HYCDDY3D 0HYCDDYC2 0HYCDDY34 0HYCDDY3F 0JAET01AW…
Every code shown here, 1,995 characters
Model Number: 72081-01 UDI-DI Code: 00357599818005 Product with Expiry Date 12/31/2025 Kit Lot Numbers: T60003054 Pack Serial Numbers: 0HYCDDYCC 0HYCDDYC1 0HYCDDY3A 0HYCDDYCE 0HYCDDY32 0HYCDDY3D 0HYCDDYC2 0HYCDDY34 0HYCDDY3F 0JAET01AW 0HYCDDY33 0HYCDDY3H 0HYCDDY3E 0HYCDDY35 0HYCDDYKL 0HYCDDYKK 0JAET02A8 0JAET029Z 0HYCDDYK9 0JAET02A7 0JAET02AA 0JAET029Y 0JAET02A9 0HYCDDYKP 0JAET02A0 0HYCDDYKN 0HYCDDYKR 0JAET02A2 0HYCDDYKD 0HYCDDYKQ 0JAET02AE 0JAET02A4 0HYCDDYKF 0JAET02AD 0JAET02AG 0JAET02A6 0JAET02A3 0JAET02AF 0HYCDDY2N 0HYCDDY2C 0JAET02A5 0HYCDDY2M 0JAET01AZ 0JAET01AV 0HYCDDY2A 0HYCDDY2P 0JAET01AX 0JAET01L3 0JAET01AU 0JAET01C0 0JAET01K3 0JAET01JT 0JAET01C1 0HYCDDY2U 0HYCDDY2H 0JAET01L2 0HYCDDY2T 0JAET01L1 0JAET01KU 0HYCDDY2G 0JAET019H 0JAET01KT 0JAET01KY 0JAET01KV 0JAET01L0 0JAET01JY 0JAET01KZ 0JAET01KR 0HYCDDZKC 0HYCDDZKN 0JAET039T 0HYCDDZKA 0HYCDDZKE 0HYCDDZKQ 0HYCDDZKM 0HYCDDZKD 0JAET03AL 0JAET03AX 0HYCDDZKP 0JAET0E3M 0JAET0E3A 0JAET0E3L 0JAET0E39 0JAET0E96 0JAET0E97 0JAET0E9J 0JAET0E98 0JAET0E9K 0JAET0E99 0JAET0E9L 0JAET0E9A 0JAET0E9M 0JAET0A33 0JAET0A2M 0JAET0EA2 0JAET0EAD 0JAET0EA3 0JAET0EAE 0JAET0E9C 0JAET0E9N 0JAET0E9D 0JAET0E9P 0JAET0E9E 0JAET0E9Q 0JAET0E9F 0JAET0E9R 0JAET0E9G 0JAET0A2Y 0JAET0A2T 0JAET09JW 0HU6K8LCE 0HU6K8LC4 0HU6K8LC5 0HU6K8LC6 0HU6K8LCJ 0JAET09RA 0JAET09JQ 0HU6K8LC8 0HU6K8LC9 0HU6K8LCC 0HU6K8LCN 0HU6K8LCD 0HU6K8LCP 0JAET09RG 0JAET0E2A 0JAET0E29 0JAET0E2F 0JAET0E2K 0JAET0E2J 0JAET0E24 0JAET0E2H 0JAET0E23 0JAET09T8 0JAET09RZ 0JAET09T9 0JAET09T0 0JAET09TA 0JAET09T1 0JAET09TC 0JAET09TD 0JAET0E38 0JAET09HZ 0JAET0E28 0JAET0E2D 0JAET0E27 0JAET0E2C 0JAET04RR 0JAET04TA 0JAET04T2 0JAET04RZ 0JAET04T9 0HYCDE1JF 0JAET04T1 0JAET04TC 0HYCDE1JU 0HYCDE1J9 0JAET04T3 0JAET04TG 0HYCDE1JN 0HYCDE1JE 0HYCDE197 0HYCDE1JM 0HYCDE1A3 0HYCDE19V 0HYCDE1AF 0HYCDE1A4 0HYCDE19G 0HYCDE19T 0HYCDE1AD 0HYCDE1A2 0HYCDE19E 0HYCDE19N 0HYCDE19U 0HYCDE19F 0JAET04JU 0HYCDE19R 0HYCDE19D 0JAET04JG 0JAET04JR 0JAET04JV 0JAET04JH 0JAET04JE 0JAET04J6 0JAET04JT 0JAET04JF 0JAET04HW…
FDA’s list runs to 5,255,794 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
U.S.: AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, WI, WV, and WY. O.U.S.: Andorra, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, New Zealand, Norway, Qatar, San Marino, Spain, Sweden, Switzerland, and United Kingdom.
The states and territories these words name
36 states and territories.
Every one of them
- Alaska
- Alabama
- Arizona
- California
- Colorado
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Pennsylvania
- South Carolina
- South Dakota
- Texas
- Utah
- Virginia
- Wisconsin
- West Virginia
- Wyoming
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 24, 2025.
- FDA classified it on Jan 13, 2026.
- FDA’s Enforcement Report published it on Jan 21, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Abbott Diabetes Care, Inc., of Alameda, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,255,794 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.