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Abbott

US Last updated 30 May 2026

Devices
703
Registries
FDA 510(k)FDA PMAFDA
FDA recalls
4116 ongoing

Catalogue703

Page 15 of 15

Showing 701-703 of 703

FDA recalls41

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

Showing the 10 most recent of 41 recalls.

  • 2026

    • 10 Sep 2026 Z-0191-2027 Not yet classified Ongoing Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).via FDA establishment ABBOTT GmbH

  • 2025

    • 10 Sep 2025 Z-0109-2026 Class I Ongoing Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.via FDA establishment ABBOTT GmbH
    • 10 Sep 2025 Z-0110-2026 Class I Ongoing Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.via FDA establishment ABBOTT GmbH
    • 10 Sep 2025 Z-0111-2026 Class I Ongoing Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.via FDA establishment ABBOTT GmbH
    • 10 Sep 2025 Z-0112-2026 Class I Ongoing Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.via FDA establishment ABBOTT GmbH
    • 10 Sep 2025 Z-0113-2026 Class I Ongoing Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.via FDA establishment ABBOTT GmbH
    • 17 Mar 2025 Z-1643-2025 Class II Ongoing 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.via FDA establishment ABBOTT GmbH
    • 17 Mar 2025 Z-1644-2025 Class II Ongoing 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.via FDA establishment ABBOTT GmbH

  • 2024

    • 4 Mar 2024 Z-1479-2024 Class II Ongoing Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).via FDA establishment ABBOTT GmbH
    • 4 Mar 2024 Z-1480-2024 Class II Ongoing Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).via FDA establishment ABBOTT GmbH
Show the 25 most recent of 41 recalls

  • 2023

    • 28 Sep 2023 Z-0209-2024 Class II Ongoing Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure.via FDA establishment ABBOTT GmbH
    • 12 Jun 2023 Z-2110-2023 Class I Ongoing There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.via FDA establishment ABBOTT GmbH

  • 2022

    • 9 Jun 2022 Z-1344-2022 Class II Terminated When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter."via FDA establishment ABBOTT GmbH
    • 28 Apr 2022 Z-1213-2022 Class II Terminated Incorrect product labeling.via FDA establishment ABBOTT GmbH
    • 24 Mar 2022 Z-0956-2022 Class II Terminated Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.via FDA establishment ABBOTT GmbH
    • 24 Mar 2022 Z-0957-2022 Class II Terminated Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.via FDA establishment ABBOTT GmbH

  • 2021

    • 16 Nov 2021 Z-0420-2022 Class II Terminated As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.via FDA establishment ABBOTT GmbH
    • 9 Nov 2021 Z-0895-2022 Class II Terminated Instructions for use were updated.via FDA establishment ABBOTT GmbH

  • 2020

    • 19 Jun 2020 Z-2701-2020 Class II Terminated Quality Control results were not properly evaluated for QC failures.via FDA establishment ABBOTT GmbH
    • 22 May 2020 Z-2541-2020 Class II Terminated High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Cathetervia FDA establishment ABBOTT GmbH
    • 12 May 2020 Z-2401-2020 Class II Terminated There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.via FDA establishment ABBOTT GmbH
    • 24 Apr 2020 Z-2117-2020 Class II Ongoing Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show interaction when processed directly after the ARCHITECT iGentamicin (LN 1P31) assay and patient results might be impacted.via FDA establishment ABBOTT GmbH
    • 9 Mar 2020 Z-1728-2020 Class II Terminated An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.via FDA establishment ABBOTT GmbH
    • 28 Feb 2020 Z-1700-2020 Class II Terminated Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained.via FDA establishment ABBOTT GmbH
    • 24 Jan 2020 Z-1580-2020 Class II Terminated Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.via FDA establishment ABBOTT GmbH

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • ABBOTT GmbH Wiesbaden Hesse · DE FEI 3002809144

What Abbott makes

The company produces in vitro diagnostic (IVD) laboratory instruments and software, including analysers for spectrophotometry and chemiluminescent immunoassays, as well as related reagents and kits for testing hepatitis A, hepatitis B, and gamma-glutamyltransferase (GGT). It also manufactures single-use cardiac mapping catheters for percutaneous procedures and buffered sample diluents for diagnostic use, alongside glucose and carbon dioxide (CO₂) testing kits.

These products are regulated under Class I and Class II classifications in the US, with some devices exempt from classification (N). They are listed in the FDA’s Unique Device Identifier (UDI) database, reflecting their authorised status for commercial distribution in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US
Website
abbott.com
Phone
+1(650)681-3470
DUNS number
080174723