Abbott Diabetes Care, Inc.

Complete recall history across all FDA and CPSC categories — 18 total recalls

Abbott Diabetes Care, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (18)

FDA medical device enforcement actions by Abbott Diabetes Care, Inc.

Date Product Reason Class
Nov 24, 2025 FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The F... Due to a manufacturing process issue that may cause carbon build up in the se... Class I
Nov 24, 2025 FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The F... Due to a manufacturing process issue that may cause carbon build up in the se... Class I
Nov 24, 2025 FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The F... Due to a manufacturing process issue that may cause carbon build up in the se... Class I
Nov 24, 2025 FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeSt... Due to a manufacturing process issue that may cause carbon build up in the se... Class I
Jul 24, 2024 FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 ... Users of the FreeStyle Libre 3 sensors reported situations where they were re... Class I
Jul 12, 2023 FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Li... If blood glucose monitoring system users attempt to start a new sensor, when ... Class II
Feb 13, 2023 FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the ... Lithium-ion batteries in glucose monitoring system readers may swell, overhea... Class I
Feb 13, 2023 FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the ... Lithium-ion batteries in glucose monitoring system readers may swell, overhea... Class I
Feb 13, 2023 FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the ... Lithium-ion batteries in glucose monitoring system readers may swell, overhea... Class I
Feb 9, 2023 FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when use... If using affected glucose monitoring app on Android 13 Operating System, exte... Class II
Nov 14, 2019 FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 000938... Instructions sent in a letter or in instructions for use for disinfecting blo... Class II
Nov 14, 2019 Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653 Instructions sent in a letter or in instructions for use for disinfecting blo... Class II
Nov 14, 2019 Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023,... Instructions sent in a letter or in instructions for use for disinfecting blo... Class II
Feb 19, 2014 FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Dis... Abbott Diabetes Care has identified through internal testing and investigatio... Class I
Feb 19, 2014 FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. S... Abbott Diabetes Care has identified through internal testing and investigatio... Class I
Nov 18, 2013 FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. ... Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produc... Class I
Nov 18, 2013 FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 co... Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produc... Class I
Apr 15, 2013 FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic ... AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle ... Class I

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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