The Recall Desk

Manufacturer

Abbott Laboratories

86 recalls in our database name Abbott Laboratories as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 86

  • ModerateFDA (Devices)·Z-0961-2026·2025-12-24

    Abbott Alinity Chemistry Analyzer Software Corrected for Erroneous Results

    Abbott is correcting software in Alinity ci-series chemistry analyzers (versions 3.6.1 and lower) that could produce erroneous results for multiple analytes. The issue was discovered during internal testing.

    Product
    Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2026·2025-11-19

    Medical Device Software Bug Prevents Proper Result Flagging in Laboratory Analyzer

    The Alinity hq Analyzer has a software defect that fails to properly flag test results when saturation is present, potentially resulting in incorrect laboratory findings.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1653-2025·2025-04-30

    Medical device software malfunction may use expired reagents

    Abbott's CELL-DYN Ruby hematology analyzer contains a software flaw that masks expired reagent warnings, potentially allowing use of expired reagents in patient testing.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1656-2025·2025-04-30

    Abbott CELL-DYN Ruby Hematology Analyzer Recall for Expired Reagent Handling Defect

    Abbott is recalling CELL-DYN Ruby hematology analyzers that silently accept expired reagents without user notification, potentially allowing inaccurate laboratory test results.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1655-2025·2025-04-30

    Abbott CELL-DYN Ruby analyzer silently accepts expired reagents

    Abbott's CELL-DYN Ruby analyzer has a software defect where expired reagents cause it to change their expiration dates without alerting operators, risking inaccurate test results.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1652-2025·2025-04-30

    Medical analyzer software permits expired reagent use without notification

    Abbott's CELL-DYN Ruby analyzer has a software defect allowing expired reagents to be used without notification. The system incorrectly changes expiration dates to current or future dates.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1654-2025·2025-04-30

    CELL-DYN Ruby Hematology Analyzer Fails to Warn of Expired Reagents

    Abbott's CELL-DYN Ruby hematology analyzers contain a software bug that automatically changes expired reagent dates without notifying users, potentially allowing use of outdated reagents.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2681-2024·2024-08-28

    Alinity hq Analyzer May Generate Incorrect Blood Test Results

    Abbott's Alinity hq Analyzer has been recalled due to software issues that can produce incorrect blood cell counts and hemoglobin measurements in certain circumstances. No illnesses have been reported.

    Product
    Alinity hq Analyzer, REF: 09P68-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1476-2024·2024-04-10

    Abbott ARCHITECT STAT Myoglobin Reagent Kit recalled due to manufacturing defect

    Abbott is recalling certain myoglobin test kits because of manufacturing defects that could lead to incorrect results and delayed heart attack diagnosis.

    Product
    ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0680-2024·2024-01-17

    Abbott Alinity i Processing Module Recalled for Unlabeled Latex Subcomponent

    Abbott Laboratories is recalling 1,325 Alinity i Processing Module systems due to unlabeled dry natural rubber (latex) subcomponents. Users with latex allergies may be at risk of exposure.

    Product
    Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology.
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0681-2024·2024-01-17

    Abbott Alinity c Chemistry Analyzer Contains Unlabeled Latex Subcomponent

    Abbott Laboratories is recalling 1,127 Alinity c Processing Module chemistry analyzers because unlabeled latex subcomponents are present. Users with latex allergies may experience serious allergic reactions upon contact.

    Product
    Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinit
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0682-2024·2024-01-17

    ARCHITECT c4000 Processing Module recalled for unlabeled latex component

    Abbott ARCHITECT c4000 Processing Module laboratory analyzers are recalled due to unlabeled dry natural rubber (latex) subcomponents. Individuals with latex allergies may experience allergic reactions if exposed to the undisclosed component.

    Product
    ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0613-2024·2024-01-03

    Alinity ci-series System Control Module Software Performance Issues Recalled

    Abbott Laboratories is recalling 8,424 Alinity ci-series System Control Module units due to software performance issues that could produce erroneous test results. Affected systems are used in clinical laboratories throughout the United States and 90+ countries.

    Product
    Alinity ci-series System Control Module, REF: 03R70-01
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0604-2024·2023-12-27

    Abbott Hematology Analyzers Recalled for Unlabeled Latex Component

    Abbott CELL-DYN Ruby and Sapphire hematology analyzers contain latex that is not labeled on the device, posing a risk to users with latex allergies. The recall affects 670 devices distributed across 33 states, Puerto Rico, and Brazil.

    Product
    Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Food)·F-0328-2024·2023-11-15

    Infant Probiotic Supplement Recall: Abbott Similac Tri-Blend Unsafe Additive

    Abbott Laboratories has recalled Similac Probiotic Tri-Blend infant supplement packets due to regulatory violations: the product was marketed without FDA approval as a new drug and contains an unsafe food additive.

    Product
    Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0698-2023·2023-04-19

    Zone Perfect Fudge Graham bars recalled for hard plastic fragments

    Abbott Laboratories is recalling Zone Perfect Fudge Graham bars due to potential hard plastic fragments in the product. Affected bars were distributed to 36 U.S. states.

    Product
    Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton
    Category
    Food
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-0958-2023·2023-01-25

    Abbott Alinity Reaction Vessels Recalled for Potential Contaminant

    Abbott Laboratories recalled 70 cases of Alinity Reaction Vessels due to potential contamination that could affect optical performance. Units were distributed across multiple U.S. states.

    Product
    Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Food)·F-0160-2023·2022-11-23

    Similac Neosure Infant Formula Recalled Due to Compromised Seal Integrity

    Abbott Laboratories is recalling Similac Neosure 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. Approximately 14.5 million bottles distributed nationwide and internationally are affected.

    Product
    Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0154-2023·2022-11-23

    Pedialyte Unflavored Electrolyte Solution Recalled for Seal Integrity Issues

    Abbott Laboratories is recalling Pedialyte Unflavored Electrolyte Solution 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. The recall affects 14,588,544 bottles distributed in the US and internationally.

    Product
    Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0158-2023·2022-11-23

    Similac Infant Formula Recalled Due to Compromised Seal Integrity

    Abbott Laboratories is recalling Similac 360 Total Care Sensitive infant formula in 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. Approximately 15.9 million bottles are affected across the United States and international locations.

    Product
    Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0156-2023·2022-11-23

    Similac 360 infant formula recalled for compromised seal integrity

    Abbott Laboratories is recalling Similac 360 Total Care infant formula in 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. The affected product has been widely distributed domestically and internationally.

    Product
    Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0162-2023·2022-11-23

    Similac Special Care infant formula recalled for compromised seal

    Abbott Laboratories is recalling Similac Special Care 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. Affected bottles have batch number 41861N200 with a best-by date of 06/01/23.

    Product
    Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count carton
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0159-2023·2022-11-23

    Similac 360 Total Care Sensitive infant formula recalled due to compromised seal integrity

    Abbott Laboratories is recalling Similac 360 Total Care Sensitive infant formula due to compromised seal integrity that could lead to spoilage. Affected consumers should not use the product and contact Abbott for further instructions.

    Product
    Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count carton
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0164-2023·2022-11-23

    Similac Stage 1 infant formula recalled for seal integrity compromise

    Abbott Laboratories is recalling Similac Stage 1 infant formula due to compromised seal integrity that could lead to product spoilage. Affected batches were distributed across the U.S., Canada, and Latin America.

    Product
    Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0161-2023·2022-11-23

    Similac Total Comfort infant formula recalled for compromised seal integrity

    Abbott Laboratories is recalling Similac Total Comfort 2 fl oz bottles due to compromised seal integrity that could allow spoilage. Approximately 14.5 million bottles are affected across the US and international markets.

    Product
    Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 count case
    Category
    Food
    Distribution
    1 state