Class I U.S. Food and Drug Administration

Abbott Diabetes Care, Inc. FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code recall: Due to a manufacturing process issue that may cause carbon build

Recall published 9 months ago

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1021-2026
Published
January 21, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Abbott Diabetes Care, Inc.
Product type
Medical devices
Units affected
1,663,241 sensors
Distribution
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
Made in
United States
Lot / code info
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 0HU6HAW1Z 0HU6HAW1Y 0HU6HAW1K 0HU6HAW1X 0HWD9FW3D 0HWD9FW3Q 0HWD9FW3U 0HWD9FW3N 0HWD9FW3T 0HWD9FW3F 0J8A18P43 0J8A18P3R 0J8A18P3H 0J8A18P3T 0J8A18P3U 0J8A18P3K 0J8A18P3V 0HWD9FW38 0J8A18P3W 0HWD9FW39 0HWD9FW3A 0HWD9FW3L 0J8A18P3L 0HWD9FW3M 0J8A18P3M 0J8A18P3X 0J8A18P3N 0J8A18P3Y 0J8A18P3P 0J8A18P3Q 0J8A18P42 0HWD9FW3E 0HWD9FWJY 0HWD9FWJZ 0HWD9FWK8 0HWD9FWKA 0HWD9FWLG 0HWD9FWL5 0HWD9FWLH 0HWD9FWL6 0HWD9FWLJ 0HWD9FWKC 0HWD9FWK3 0HWD9FWKE 0HWD9FWKG 0HWD9FWLM 0HWD9FWLA 0HWD9FWLN 0HWD9FWLC 0HWD9FWLP 0HWD9FWLD 0HKCN6KMA 0HKCN6KLZ 0HKCN6KM9 0HPCNHRTG 0HPCNHRTU 0HPCNHRTH 0HPCNHRTV 0HPCNHRTJ 0HPCNHRTW 0HPCNHRTK 0HKCN6KLX 0HPCNHRTL 0HKCN6KLW 0HKCN6KM6 0HKCN6KM5 0HKCN6KM4 0HPCNHRTN 0HPCNHRU0 0HPCNHRTP 0HPCNHRU1 0HPCNHRTQ 0HPCNHRTX 0HPCNHRTR 0HPCNHRUE 0HPCNHRU3 0HPCNHRUF 0HPCNHRU4 0HPCNHRUG 0HPCNHRU5 0HPCNHRUH 0HPCNHRU6 0HPCNHRUJ 0HPCNHRU7 0HPCNHRV1 0HPCNHRV2 0HPCNHRUR 0HPCNHRU2 0HPCNHRUK 0HPCNHRU8 0HPCNHRUL 0HPCNHRU9 0HPCNHRUM 0HPCNHRUA 0HPCNHRUN 0HPCNHRUC 0HPCNHRUP 0HPCNHRUD 0HPCNHRV6 0HPCNHRUW 0HPCNHRV7 0HPCNHRW5 0HPCNHT3Y 0HPCNHRW7 0HPCNHT42 0HPCNHT47 0HPCNHT41 0HPCNHRW4 0HPCNHRVN 0HPCNHRVC 0HPCNHRVP 0HPCNHRVD 0HPCNHRVF 0HPCNHRVE 0HPCNHRVG 0HPCNHRVR 0HKCN6KKH 0HPCNHRVT 0HKCN6KKG 0HKCN6KK6 0HPCNHT3X 0HKCN6KK5 0HPCNHT3W 0HPCNHT46 0HPCNHRVV 0HPCNHRVH 0HPCNHRVW 0HPCNHRVJ 0HPCNHRVK 0HPCNHRVM 0HWD9FUKH 0HWD9FUKU 0HWD9FUKT 0HWDCHECF 0HWDCHEC2 0HWDCHECG 0HWDCHECC 0HWDCHEC4 0HWD9FUL9 0HWDCHEC0 0HWDCHEC1 0HWDCHECX 0HWDCHECY 0HWDCHECM 0HWDCHECZ 0HWDCHECN 0HWDCHECQ 0HWDCHECP 0HWD9FUKF 0HWDCHED1 0HWDCHECJ 0HWDCHECH 0HWDCHECV 0HWDCHEC6 0HWDCHECK 0HWDCHEC7 0HWDCHED2 0HWDCHECR 0HWDCHED3 0HWDCHECT 0HWDCHED4 0HWDCHECU 0HWDCHECW 0HWD9FUK8 0HWDCHED6 0HWD9FUKE 0HWD9FUJY 0HWD9FUKD 0HWD9FUK1 0HWD9FUK9 0HWD9FUK2 0HWD9FUJZ 0HWDCHED9 0HWD9FUKA 0HWDCHED8 0HWDCHEM5 0HWD9FUK0 0HWDCHED7 0HWDCHEDA 0HWDCHEM3 0HWDCHEM6 0HWD9FUK6 0HWDCHEM4 0HWD9FUJW 0HWD9FUK7 0HWDCHE1V 0HWDCHEHK 0HWDCHEJ0 0HWDCHEJC 0HWDCHEHZ 0HWDCHEJA 0HWD9FUU8 0HWDCHEJ9 0HWDCHEHJ 0HWD9FUUL 0HWDCHEH6 0HWDCHEHH 0HWDCHEH5 0HWDCHEHG 0HWDCHEH4 0HWDC…
UPC codes
00357599844011

Products covered by this recall

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.

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00357599844011

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 12
  • 31

Package size

Match the net weight or the piece count on the front of the pack.

  • 8 L
  • 3 L

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Abbott Diabetes Care, Inc. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Abbott Diabetes Care, Inc. — 1360 S Loop Rd, Alameda, CA, 94502-7000

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Abbott Diabetes Care, Inc. medical devices recalled?

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00357599844011; best-by date 12 or 31. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Which states were affected?

The notice lists Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas and others.

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