Class I U.S. Food and Drug Administration

Abbott Diabetes Care, Inc. FreeStyle Libre 3 Sensor REF 72081-01 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-1020-2026
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
1,060,723 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: 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 0JAET04J4 0JAET04JD 0JAET04HU 0JAET04JN 0JAET04J5 0JAET04HV 0JAET04JA 0JAET04JL 0JAET04JP 0JAET04JC 0JAET04J1 0JAET04JM 0JAET04J9 0JAET04HQ 0JAET04HZ 0JAET04J7 0JAET04RQ 0JAET041P 0JAET04J0 0JAET04RP 0JAET041N 0JAET041R 0JAET041Q 0JAET041V 0JAET041L 0JAET0418 0JAET041T 0JAET041M 0JAET040Y 0JAET0416 0JAET040Z 0JAET04KV 0JAET04K4 0JAET04KL 0JAET04KW 0JAET04JY 0JAET04K2 0JAET04KH 0JAET04JZ 0HYCDDZKF 0JAET039N 0JAET039M 0HYCDDZKH 0HYCDDZKV 0JAET039Y 0HYCDDZKK 0HYCDDZKT 0HYCDDZKJ 0JAET03AR 0JAET03C2 0HYCDDZKW 0HYCDDZKL 0JAET03AZ 0HYCDDZKZ 0JAET03AM 0JAET03AQ 0JAET03C1 0JAET03AP 0HYCDDZV9 0HYCDDZUY 0JAET03C0 0HYCDDZVA 0HYCDDZUW 0HYCDDZV6 0HYCDDZUZ 0HYCDDZV8 0JAET03AU 0JAET03C4 0HYCDDZV7 0JAET03AT 0JAET03AW 0JAET03C6 0JAET03C3 0JAET03AV 0HYCDDZV4 0HYCDDZUT 0JAET03C5 0HYCDDZV5 0HYCDDZUQ 0HYCDDZV0 0HYCDDZV3 0JAET03UY 0HYCDE03C 0JAET03UX 0JAET03V8 0JAET03UA 0JAET03V6 0JAET03UZ 0HYCDE035 0JAET03V0 0HYCDE033 0JAET03V1 0JAET03V9 0HYCDE036 0JAET03A1 0JAET03AH 0JAET03VC 0JAET03A0 0JAET03A3 0JAET03AK 0JAET03AG 0JAET03A2 0JAET039A 0JAET039P 0JAET03AJ 0JAET03A4 0JAET039E 0JAET039R 0JAET031P 0JAET039C 0JAET03A6 0JAET03AC 0JAET039Q 0JAET03A5 0JAET03A8 0JAET03AE 0JAET03AA 0JAET03A7 0JAET0AAR 0JAET0AAH 0JAET0AAJ 0JAET0AAV 0JAET0AAK 0JAET0AAW 0JAET0EHH 0JAET0EH6 0JAET0EHA 0JAET0EH9 0JAET0EHK 0JAET0EH8 0JAET0EHJ 0JAET0EH7 0JAET0ERD 0JAET0ER3 0JAET0ERE 0JAET0ER4 0JAET0ERF 0JAET0ER5 0JAET0ERG 0JAET0EHG 0JAET0EH4 0JAET0EHE 0JAET0EH3 0JAET0EHD 0JAET0EH2 0JAET0ERK 0JAET0ER8 0JAET0ER7 0JAET0ERA 0JAET0ERM 0JAET0ERJ 0JAET0ER9 0JAET0ERL 0JAET09T3 0JAET09TE 0JAET09T5 0JAET09TG 0JAET09T6 0JAET09TH 0JAET09T7 0JAET09TJ 0JAET0E33 0JAET0E2Y 0JAET0E2X 0JAET0E2W 0JAET0E35 0JAET0E2V 0JAET0E34 0JAET0E2U 0JAET09TW 0JAET09TL 0JAET09TX 0JAET09TY 0JAET09TN 0JAET0E2T 0JAET0E32 0JAET0E2R 0JAET0E31 0JAET0E2Q 0JAET0E30 0JAET0E2P 0JAET0E2Z 0JAET0A3P 0JAET0A3D 0JAET0A3N 0JAET0A3C 0JAET0A3M 0JAET0A3A 0JAET0A3L 0JAET09VN 0JAET09VZ 0JAET09VP 0JAET09W0 0JAET09VQ 0JAET09W1 0JAET0A3K 0JAET0A38 0JAET0A3J 0JAET0A37 0JAET0A3H 0JAE…
UPC codes
00357599818005

Products covered by this recall

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.

Check your product

The notice names 7 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.

  • 00357599818005

Best-by / use-by date

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

  • 12
  • 31

Model or item number

On the rating label, the box or the instruction sheet.

  • 31

Package size

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

  • 3 L
  • 9 L
  • 041 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. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

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 00357599818005; best-by date 12 or 31; model number 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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