Abbott
21 federal recalls on file, showing the 15 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Abbott and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-06-17FDA-DeviceClass IIAbbott Merlin PCS 3650 programmer software recalled for test termination malfunction
Abbott's Merlin PCS 3650 programmer software (versions 25.0.1 through 28.7.1) may malfunction during pacing capture threshold tests on pacemakers. When this occurs, the programmer may fail to successfully send the command to stop the test.
- 2026-03-25FDA-DeviceClass IIStop using Abbott ID NOW flu test kit
Abbott Diagnostics has recalled certain lots of the ID NOW Influenza A & B 2 test kit because they produce an unusually high number of invalid results compared to what the instructions say to expect. Invalid results mean the test does not give a clear positive or negative answer, requiring a retest.
- 2026-01-21FDA-DeviceClass IStop using recalled FreeStyle Libre 3 Plus sensors
Abbott Diabetes Care is recalling certain FreeStyle Libre 3 Plus continuous glucose monitoring sensors due to a manufacturing issue that may cause carbon buildup inside the sensor. This buildup could lead to incorrect low blood sugar readings, which may not alert you when your glucose is actually low.
- 2026-01-21FDA-DeviceClass IStop using affected FreeStyle Libre 3 Plus sensors
Abbott has recalled certain FreeStyle Libre 3 Plus glucose sensors due to a manufacturing issue that may cause carbon buildup inside the sensor. This buildup can result in the sensor showing incorrect low blood sugar readings when your actual glucose is normal or higher. The recall affects specific lot numbers with expiration date of 01/31/2026.
- 2026-01-21FDA-DeviceClass IStop using Abbott FreeStyle Libre 3 Plus sensors
Abbott has recalled certain FreeStyle Libre 3 Plus glucose sensors due to a manufacturing issue that may cause carbon buildup inside the sensor. This buildup could result in the sensor showing incorrect low blood sugar readings when your actual glucose is normal or high.
- 2026-01-21FDA-DeviceClass IStop using Abbott FreeStyle Libre 3 sensors
Abbott is recalling certain FreeStyle Libre 3 sensors due to a manufacturing defect that may cause carbon buildup inside the sensor. This buildup can result in the sensor showing incorrect low blood sugar readings when your actual glucose level is normal or higher. The recall affects sensors with specific lot and serial numbers expiring by December 31, 2025.
- 2025-12-24FDA-DeviceClass IIUpdate your Abbott Alinity ci-series software
Abbott Laboratories is recalling certain Alinity ci-series System Control Modules with software version 3.6.1 or lower due to a performance issue that could produce inaccurate lab test results. The issue affects multiple analytes and was discovered during Abbott's internal testing.
- 2025-11-19FDA-DeviceClass IIBrand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No
Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
- 2025-11-19FDA-DeviceClass IILiberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).
- 2025-11-19FDA-DeviceClass IIEterna SCS IPG (Implantable Pulse Generator), Model Number 32400
There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).
- 2025-10-22FDA-DeviceClass ITactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- 2025-10-22FDA-DeviceClass ITactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- 2025-10-22FDA-DeviceClass ITactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- 2025-10-22FDA-DeviceClass ITactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- 2025-10-22FDA-DeviceClass ITactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
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