Class I U.S. Food and Drug Administration

Abbott Diabetes Care, Inc. FreeStyle Libre 3 Plus Sensor REF 78769-01 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

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

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-1022-2026
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
258,913 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: 78769-01 UDI-DI Code: 00357599843014 Product Expiry Date: 01/31/2026 Kit Pack Lot Number: T60003166 Pack Serial Numbers: 0HPCMWH9Y 0HPCMWHAV 0HPCMWHA9 0HPCMWHA0 0HPCMWHAK 0HPCMWHAR 0HPCMWHAU 0HPCMWHAJ 0HPCMWHAG 0J8A08TUA 0HPCMWHAQ 0HPCMWHAF 0J8A08TTZ 0J8A08TUD 0HPCMWHAT 0J8A08TTY 0J8A08TU1 0HPCMWHAZ 0J8A08TUC 0J8A08TU0 0HPCMWHC9 0HPCMWHAX 0J8A08TUE 0J8A08TU2 0HPCMWHAM 0J8A08TUG 0HPCMWHAW 0HPCMWHAL 0J8A08TU5 0J8A08TUJ 0HPCMWHAY 0J8A08TU3 0J8A08TU8 0HPCMWHC4 0J8A08TUH 0J8A08TU7 0HPCMWHL8 0J8A08TW4 0HPCMWHLL 0HPCMWHL9 0J8A08U3T 0J8A08U45 0J8A08TW3 0J8A08U3U 0J8A08U3Q 0J8A08U3N 0J8A08TW5 0J8A08U3R 0J8A08U3C 0J8A08U3L 0J8A08TW1 0J8A08U39 0J8A08U31 0J8A08U3M 0J8A08U3A 0J8A08U2Q 0J8A08U2Z 0J8A08U3K 0J8A08U2N 0J8A08U3H 0J8A08U30 0J8A08U2P 0J8A08U36 0J8A08U43 0J8A08TV2 0J8A08U34 0J8A08U2W 0J8A08U3G 0J8A08U35 0J8A08U2K 0J8A08U2U 0J8A08U3E 0J8A08U38 0J8A08U2H 0J8A08U2L 0J8A08U2V 0J8A08U2J 0HPCMWHKW 0J8A08U2Y 0J8A08U2X 0HPCMWHL5 0HPCMWHKU 0J8A18G45 0J8A18G29 0J8A18G20 0J8A18G3W 0J8A18G3Y 0J8A18G2C 0J8A18G22 0J8A18G1Z 0J8A18G2A 0J8A18FWA 0J8A18G40 0J8A18G21 0HPD38KT2 0HPD38KTF 0HPD38KTG 0HPD38KTR 0HPD38KTH 0HPD38KTT 0HPD38KTJ 0JH6L4FC0 0JH6L4FAP 0JH6L4FC1 0JH6L4FAQ 0HPD38KRW 0JH6L4FAR 0HPD38KT8 0HPD38KT7 0HPD38KTL 0HPD38KTK 0HPD38KTM 0HPD38KTA 0HPD38KTN 0HPD38KTC 0HPD38KTP 0HPD38KTD 0JH6L4FAV 0JH6L4FC6 0JH6L4FAW 0JH6L4FC2 0JH6L4FAX 0JH6L4FC3 0HPD38KR5 0J8A18G1R 0J8A18G1K 0HPD38KRK 0J8A18G1T 0J8A18G1V 0J8A18G1H 0J8A18G1L 0J8A18G1W 0J8A18G82 0J8A18G8R 0J8A18G1J 0J8A18G1U 0J8A18G85 0J8A18G8U 0J8A18G8Q 0J8A18G84 0J8A18G88 0J8A18G1E 0J8A18G1P 0J8A18G1C 0J8A18G1F 0J8A18G1Q 0JH6L4FAT 0JH6L4FC4 0JH6L4FAU 0HPD38KUV 0HPD38KUJ 0HPD38KUW 0HPD38KUX 0HPD38KUL 0HPD38KUY 0HPD38KUM 0HPD38KUZ 0HPD38KUN 0JH6L4FC7 0J8A18GLT 0JH6L4FC8 0JH6L4Q11 0JH6L4Q0Y 0JH6L4Q19 0JH6L4Q0Z 0JAEYKEHA 0JAEYKEHQ 0JAEYKEHN 0JAEYKEHC 0JAEYKEHE 0JAEYKEH5 0JAEYKEHR 0JAEYKEHF 0JAEYKERA 0JAEYKEH3 0JAEYKEHP 0JAEYKEHD 0JAEYKERD 0JAEYKER3 0JAEYKEH4 0JAEYKERC 0JAEYKERF 0JAEYKEHK 0JAEYKER2 0JAEYKERE 0JAEYKEH8 0JAEYKER4 0JAEYKEHL 0JAEYKEH9 0JAEYKERG 0JAEYKER6 0JAEYKEH6 0JAEYKERJ 0JAEYKER9 0JAEYKERH 0JAEYKERL 0JH6L4Q0V 0JAEYKER8 0JAEYKERK 0JH6L4Q0J 0JH6L4Q0T 0JH6L4Q0X 0JH6L4Q0K 0JH6L4Q0G 0JAEYKET8 0JH6L4Q0U 0JH6L4Q0H 0JAEYKETK 0JAEYKETA 0JH6L4Q0R 0JH6L4Q0F 0JAEYKETM 0JH6L4Q0P 0JAEYKET9 0JAEYKETL 0JH6L4Q0D 0JH6L4Q0M 0JH6L4Q0Q 0JH6L4Q0E 0JH6L4Q0A 0JAEYKETE 0JH6L4Q0N 0JH6L4Q0C 0JAEYKETQ 0JH6L4Q0L 0JH6L4Q09 0JAEYKETT 0JAEYKETD 0JAEYKETF 0JAEYKETR 0JAEYKETP 0JAEYKERN 0JAEYKETC 0JAEYKETN 0JAEYKERZ 0JAEYKERQ 0JAEYKERM 0JAEYKERY 0JAEYKET1 0JAEYKETW 0JH6L4M8M 0JH6L4M8Z 0JH6L4M93 0JH6L4M02 0JH6L4M8P 0JH6L4M91 0JH6L4M8C 0JH6L4M81 0JH6L4M8R 0JH6L4M8A 0JH6L4M88 0JH6L4M03 0JH6L4M01 0JH6L4M86 0JH6L4M9F 0JH6L4M04 0JH6L4M89 0JH6L4M9H 0JH6L4M97 0JH6L4M94 0JH6L4M9G 0JH6L4M9K 0J8A18NCP 0JH6L4M96 0JH6L4M9J 0JH6L4M8E 0JH6L4M83 0JH6L4M98 0JH6L4M8D 0JH6L4M9L 0JH6L4M9A 0JH6L4M82 0JH6L4M8F 0JH6L4M9N 0JH6L4M9D 0JH6L4M99 0JH6L4M9M 0JH6L4M9Q 0J8A18NCW 0JH6L4M9C 0JH6L4M9P 0JH6L4N2D 0JH6L4N22 0JH6L4N25 0JH6L4N2E 0HPD2HD46 0JH6L4N23 0HPD2HD47 0JH6L4N2C 0JH6L4N21 0HPD2HD3V 0HPD2HCW0 0JH6L4N29 0JH6L4N1Z 0HPD2HD49 0JH6L4N2A 0JH6L4N27 0JH6L4N1X 0JH6L4N20 0JH6L4N28 0HPD2HD3Z 0HPD2HD3M 0JH6L4N1Y 0HPD2HD40 0HPD2HD44 0HPD2HD3Q 0HPD2HD3N 0HPD2HCV0 0HPD2HCVC 0HPD2HD3T 0HPD2HD41 0HPD2HCV3 0HPD2HCVE 0HPD2HD3P 0HPD2HCV1 0HPD2HCV5 0HPD2HCVG 0HPD2HCVD 0HPD2HCV4 0JH6L4LRF 0J8A18N3X 0J8A18N3E 0JH6L4LRT 0J8A18N3Y 0J8A18N3R 0J8A18N3H 0J8A18N3F 0J8A18N3W 0JH6L4LRU 0JH6L4LT5 0JH6L4LRW 0JH6L4LT7 0JH6L4LT4 0JH6L4LRV 0JH6L4LRY 0JH6L4LTR 0JH6L4LT6 0JH6L4LRX 0JH6L4LTG 0JH6L4LR2 0JH6L4LT8 0JH6L4LTF 0JH6L4LRZ 0JH6L4LTA 0J8A18N3D 0J8A18N3Q 0JH6L4LT1 0JH6L4LTD 0JH6L4LT9 0JH6L4LT0 0JH6L4LT3 0JH6L4LTC 0JH6L4LT2 0JH6L4LTM 0JH6L4LTU 0JH6L4LTE 0JH6L4LTL 0J8A18N1L 0J8A18N1F 0JH6L4LW6 0JH6L4M49 0J8A18N1N 0J8A18N1G 0JH6L4LW4 0J8A18N1M 0J8A18N1Q 0J8A18N22 0J8A18N21 0J8A18N1P 0JH6L4LWA 0J8A18N1H 0JH6L4LWC 0J8A18N1R 0J8A18N1X 0JH6L4LW1 0J8A18N1U 0J8A18N1Z 0JH6L4LVZ 0J8A18N1T 0J8A18N1W 0J8A18N27 0J8A18N1Y 0J8A18N1V 0J8A18N2F 0J8A18N24 0J8A18N20 0J8A…
UPC codes
00357599843014

Products covered by this recall

FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

Check your product

The notice names 8 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.

  • 00357599843014

Best-by / use-by date

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

  • 01
  • 31

Package size

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

  • 3 L
  • 2 L
  • 1 L
  • 0 L
  • 9 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. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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 00357599843014; best-by date 01 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?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

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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