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Abbott Laboratories

Abbott Laboratories Recalls

All product recalls associated with Abbott Laboratories.

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Recall Summary

Total Recalls

154

Past Year

19

Class I (Serious)

41

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 154 recalls

Alinity ci-series System Control Module (SCM), REF: 03R70... (Abbott Laboratories) – abbott laboratories is recalling thei... (2025)

Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.

FDANov 13, 2025Nationwide• Abbott Laboratories

Eterna SCS IPG (Abbott) – potential device issue (2025)

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).

FDAOct 6, 2025Nationwide• Abbott Medical

Liberta RC DBS IPG (Abbott) – potential device issue (2025)

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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).

Moderate

FDAOct 6, 2025Nationwide• Abbott Medical

Alinity hq Analyzer (Abbott) – Result Flagging Issue (2025)

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.

FDASep 18, 2025Nationwide• Abbott Laboratories

TactiFlex Ablation Catheter (Abbott) – Tip Detachment Risk (2025)

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

FDASep 10, 2025Nationwide• Abbott

i-STAT CG4+ Cartridge (Abbott) – Measurement Range Issue (2025)

Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.

FDAAug 21, 2025Nationwide• Abbott Point Of Care Inc.

i-STAT EG6+ Cartridge (Abbott) – Sample Type Issue (2025)

Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.

FDAAug 21, 2025Nationwide• Abbott Point Of Care Inc.

i-STAT EG7+ Cartridge (Abbott) – Sample Type Issue (2025)

Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.

FDAAug 21, 2025Nationwide• Abbott Point Of Care Inc.

i-STAT CG8+ Cartridge (Abbott) – Sample Type Problem (2025)

Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.

FDAAug 21, 2025Nationwide• Abbott Point Of Care Inc.

Alinity m Resp-4-Plex Kit (Abbott) – Test Result Anomalies (2025)

There were reports of an increase in reactive negative controls and false positive results.

FDAApr 28, 2025Nationwide• Abbott Molecular, Inc.

Alinity m Resp-4-Plex Kit (Abbott) – Test Result Anomalies (2025)

There were reports of an increase in reactive negative controls and false positive results.

FDAApr 28, 2025Nationwide• Abbott Molecular, Inc.

Alinity m System (Abbott Molecular) – liquid waste risk (2025)

The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.

FDAMar 20, 2025Nationwide• Abbott Molecular, Inc.

CELL-DYN Ruby (Abbott) – reagent expiration error (2025)

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

FDAMar 18, 2025Nationwide• Abbott Laboratories

Amplatzer TorqVue LP Catheter (Abbott) – shaft breach (2025)

Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.

FDAMar 17, 2025Nationwide• Abbott

Amplatzer TorqVue LP Delivery System (Abbott) – shaft breach (2025)

Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.

FDAMar 17, 2025Nationwide• Abbott

ID NOW RSV Test (Abbott) – High Invalid Rate (2025)

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

FDAMar 4, 2025Nationwide• Abbott Diagnostics Scarborough, Inc.

ID NOW Influenza A/B Test (Abbott) – High Invalid Rate (2025)

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

FDAMar 4, 2025Nationwide• Abbott Diagnostics Scarborough, Inc.

ID NOW COVID-19 Test (Abbott) – High Invalid Rate (2025)

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

FDAMar 4, 2025Nationwide• Abbott Diagnostics Scarborough, Inc.

Aveir DR Leadless Pacemaker (Abbott) – Battery Temperature Risk (2025)

Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.

FDAFeb 15, 2025Nationwide• Abbott Medical

Merlin PCS Programmer (Abbott) – Software Anomaly (2024)

Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing.

FDANov 21, 2024Nationwide• Abbott Medical