Abbott recalls
12 federal recalls on file, showing the 7 from the last 12 months. We read every CPSC, FDA, USDA and NHTSA notice for Abbott and put it in plain English.
Recent recalls
Abbott Amplatzer Amulet occluder needs updated instructionsAbbott has updated the instructions for use for certain Amplatzer Amulet left atrial appendage occluder devices to address a risk of pulmonary artery injury during the procedure. This is a precautionary update affecting multiple model numbers across all lots and serial numbers.
ModerateFDAOct 16, 2026
- Abbott 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.
ModerateFDAJun 17, 2026
- Stop 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.
ModerateFDAMar 25, 2026
- Abbott FreeStyle Libre 3 sensors recalled for false low readings
Abbott is recalling four FreeStyle Libre 3 and Libre 3 Plus glucose sensor models, about 3 million sensors in total. A manufacturing problem may cause carbon buildup in the sensor, which can lead to incorrect low glucose results. No injuries have been reported.
SeriousFDAJan 21, 20264 products
- Update 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.
SeriousFDADec 24, 2025
- Brand 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.
FDANov 19, 2025
- Abbott Eterna and Liberta RC implants recalled for communication loss
Abbott is recalling two implantable neurostimulator models, the Eterna SCS Model 32400 and the Liberta RC DBS Model 62400, because the devices may lose communication with the clinician programmer or patient controller. The recall covers 2 products, with about 21,437 units affected worldwide. No injuries have been reported.
ModerateFDANov 19, 20252 products