Recall Register

Food, drugs, devices › Firms

Abbott Diabetes Care, Inc.

FDA recalling firm · 9 enforcement events · 18 product records · 2013–2025 · CA

Abbott Diabetes Care, Inc. has 9 FDA enforcement events on this register (18 product records) between 2013 and 2025: 9 device; the busiest year was 2023 with 3.

67% of its events are Class I; the most common class is Class I (6). 4 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
24 Nov 2025FreeStyle 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.DeviceClass I4Ongoing
24 Jul 2024FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring SystemDeviceClass I1Ongoing
12 Jul 2023FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 SystemDeviceClass II1Ongoing
13 Feb 2023FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring SystemDeviceClass I3Ongoing
9 Feb 2023FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating SystemDeviceClass II1Completed
14 Nov 2019Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144DeviceClass II3Terminated
19 Feb 2014FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system operating temperature range as outlined in your Owner's Booklet. Meter made in China; Distributed by Abbott Diabetes Care, Alameda, CA The…DeviceClass I2Terminated
18 Nov 2013FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips; for Institutional Use only 50 count: UPC 6 99073 70792 5 Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Blood Glucose test strip is intended for use in the…DeviceClass I2Terminated
15 Apr 2013FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to…DeviceClass I1Terminated

By type and class

Device9
Class I6
Class II3

Class I: 67% of this firm's events; 18% of all events on the register.

Events by year

13
15
17
19
21
23
25
Enforcement events for Abbott Diabetes Care, Inc. by year initiated.

Questions and answers

How many FDA recalls has Abbott Diabetes Care, Inc. had?

9 enforcement events (18 product records) on this register, 2013–2025: 9 device.

Are any Abbott Diabetes Care, Inc. recalls ongoing?

4 events are listed as ongoing in the current openFDA export.

What class are Abbott Diabetes Care, Inc. recalls?

6 Class I, 3 Class II. 67% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.