FreeStyle Libre 3 Plus Sensor
Medical device recall Z-1021-2026. 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
- 1,663,241 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 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
1,663,241 sensors, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number: 78768-01 UDI-DI Code:00357599844011 Product Expiry Date: 12/31/2025 Kit Pack Lot Number: T60003138 Pack Serial Numbers: 0HWDCHEU5 0HWD9FV3H 0HWD9FV36 0HWDCHEUG 0HWD9FV3J 0HWD9FV34 0HWD9FV37 0HWD9FV3G 0HWD9FUVX 0HWD9FV40…
Every code shown here, 1,994 characters
Model Number: 78768-01 UDI-DI Code:00357599844011 Product Expiry Date: 12/31/2025 Kit Pack Lot Number: T60003138 Pack Serial Numbers: 0HWDCHEU5 0HWD9FV3H 0HWD9FV36 0HWDCHEUG 0HWD9FV3J 0HWD9FV34 0HWD9FV37 0HWD9FV3G 0HWD9FUVX 0HWD9FV40 0HWD9FV35 0HWD9FV3K 0HWD9FUVZ 0HWD9FV3Y 0HWD9FV38 0HWD9FUVY 0HWD9FV3W 0HWD9FV32 0HWD9FV3Z 0HWD9FUW0 0HWD9FV2Q 0HWD9FV30 0HWD9FUW1 0HWD9FV2R 0HWD9FUW2 0HWD9FV3V 0HWD9FV31 0HWD9FV3E 0HWD9FV43 0HWD9FV33 0HWD9FUW3 0HWDCHEAD 0HWDCHEAQ 0HWDCHEAE 0HWD9FULN 0HWD9FULP 0HWD9FULM 0HWD9FULC 0HWD9FULL 0HWD9FULA 0HWDCHEAR 0HWD9FULK 0HWDCHEAT 0HWDCHEAG 0HWDCHEAU 0HWDCHEAH 0HWDCHEAV 0HWDCHEAJ 0HWDCHEAW 0HWDCHEAK 0HWD9FULH 0HWD9FULJ 0HWD9FULG 0HWD9FULD 0HWD9FULF 0HWD9FUL5 0HWD9FUL8 0HWD9FULE 0HWD9FUKR 0HWD9FUL2 0HWD9FUKQ 0HWD9FUL1 0HWD9FUKP 0HWD9FUL0 0HWD9FUKN 0HWD9FUKZ 0HWD9FUKM 0HWD9FUKY 0HWDCHEC9 0HWDCHEAX 0HWDCHECA 0HWDCHEAY 0HWD9FUL3 0HWDCHEAZ 0HWD9FUKL 0HWD9FUKX 0HWD9FUKK 0HWD9FUKW 0HWD9FUKV 0HKCMAM2P 0HKCMAM2E 0HKCMAM2N 0HKCMAM2D 0HKCMAM2M 0HKCMAM2C 0HPCNHMJT 0HKCMAM2A 0HPCNHMJX 0HPCNHMJG 0HPCNHMJW 0HPCNHN24 0HPCNHN1T 0HPCNHN23 0HPCNHN1R 0HPCNHN22 0HPCNHN1Q 0HPCNHN21 0HKCMAMK8 0HKCMAMKK 0HKCMAMK7 0HKCMAMKJ 0HKCMAMK6 0HKCMAMKH 0HKCMAM02 0HKCMAMKG 0HKCMAM01 0HKCMAM81 0HKCMAM0A 0HKCMAM82 0HKCMAM09 0HKCMAM8K 0HKCMAM88 0HKCMAM8L 0HKCMAM8M 0HKCMAM8A 0HKCMAM8N 0HKCMAM8C 0HKCMAM84 0HKCMAM8D 0HKCMAM85 0HKCMAM06 0HKCMAM86 0HKCMAM05 0HKCMAM87 0HKCMAM04 0HKCMAM8Q 0HKCMAM8E 0HKCMAM8R 0HKCMAM8T 0HKCMAM8G 0HKCMAM8U 0HKCMAM8H 0HKCMAM8P 0HKCMAM8J 0HPCNHMU7 0HPCNHMTX 0HPCNHMU8 0HPCNHMTY 0HPCNHMTZ 0HPCNHMUA 0HPCNHMU0 0HPCNHMUD 0HPCNHMU1 0HPCNHMRD 0HPCNHMT9 0HPCNHMTT 0HKCMAN0Z 0HKCMAN18 0HPCNHNR4 0HPCNHNRA 0HKCMAN0X 0HKCMAN16 0HKCMAN19 0HKCMAN0V 0HKCMAN0N 0HKCMAN17 0HKCMAN0W 0HKCMAN0A 0HWD9FW2Z 0HWD9FW2N 0HWD9FW30 0HWD9FW31 0J8A18P31 0HWD9FW32 0J8A18P32 0J8A18P3C 0J8A18P33 0J8A18P3D 0HWD9FW2R 0J8A18P3E 0HWD9FW2T 0HWD9FW33 0HWD9FW2U 0HWD9FW34 0HWD9FW2V 0HWD9FW2W 0HWD9FW36 0J8A18P3F 0HWD9FW37 0J8A18P3G 0HWD9FW3V 0HWD9FW3X 0HU6HAW21 0HU6HAW1N 0HU6HAW20 0HU6HAW1M…
FDA’s list runs to 1,333,471 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 1,333,471 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.