Abbott recalls

15 official recalls and safety alerts involving Abbott since 2022-01, from CFIA, FDA · Device, FSA. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Abbott or the relevant agency.

1. 2025-10-22
2. US
   Drugs & medicalClass I

   Abbott recalls TactiFlex 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.

   FDA · DeviceAbbottWorldwideOfficial notice →
3. 2025-04-30
4. US
   Drugs & medicalClass II

   Abbott recalls Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080

   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…

   FDA · DeviceAbbottWorldwide - US Nationwide distribution.Official notice →
5. 2024-06-14
6. UK
   Food & drinkAllergy alert

   Abbott recalls Ensure NutriVigor Plant-Based Almond flavour Nutritional Shake because of undeclared milk

   Of undeclared milk

   FSAOfficial notice →
7. 2024-04-10
8. US
   Drugs & medicalClass II

   Abbott GmbH recalls ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35

   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…

   FDA · DeviceAbbott GmbHUS Nationwide distribution.Official notice →
9. 2023-11-08
10. US
    Drugs & medicalClass II

    Abbott recalls Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator

    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.

    FDA · DeviceAbbottUS, Taiwan, and ColombiaOfficial notice →
11. 2023-07-19
12. US
    Drugs & medicalClass I

    Abbott recalls Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).

    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.

    FDA · DeviceAbbottWorldwide distribution - US Nationwide and the countries of Slovakia, Czech…Official notice →
13. 2022-10-14
14. CA
    Food & drinkClass 3

    Abbott brand Similac Sterilized Water recalled due to spoilage

    Non harmful (quality or spoilage)

    CFIAOfficial notice →
15. 2022-07-13
16. US
    Drugs & medicalClass II

    Abbott recalls Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during…

    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."

    FDA · DeviceAbbottUS Nationwide distribution.Official notice →
17. 2022-06-19
18. CA
    Food & drinkClass 1

    Certain Abbott brand powdered infant formula products recalled due to possible Cronobacter sakazakii and Salmonella

    Salmonella - Other

    CFIAOfficial notice →
19. 2022-06-08
20. US
    Drugs & medicalClass II

    Abbott recalls FIRMap" Catheter, 60mm Basket

    Incorrect product labeling.

    FDA · DeviceAbbottUS Nationwide Distribution to states of: MO, CA, OH, WA and OUS…Official notice →
21. 2022-04-27
22. US
    Drugs & medicalClass II

    Abbott recalls Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.

    Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.

    FDA · DeviceAbbottWorldwide distribution - US Nationwide - there was government distribution but…Official notice →
23. 2022-04-13
24. US
    Drugs & medicalClass II

    Abbott recalls Amplatzer Steerable Delivery Sheath

    Instructions for use were updated.

    FDA · DeviceAbbottOUS distribution onlyOfficial notice →
25. 2022-02-20
26. UK
    Food & drinkProduct recall

    Abbott recalls two infant formula powders because of the possible presence of Salmonella

    Of the possible presence of salmonella

    FSAOfficial notice →
27. 2022-02-17
28. CA
    Food & drinkClass 1

    Certain Abbott brand powdered infant formula products recalled due to Cronobacter sakazakii and Salmonella

    Salmonella - Other

    CFIAOfficial notice →
29. 2022-01-05
30. US
    Drugs & medicalClass II

    Abbott recalls Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM

    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…

    FDA · DeviceAbbottWorldwide distribution - US Nationwide distribution in the state of Missouri…Official notice →