Abbott Laboratories: 68 recalls on record

Recalls filed with 1 agency: FDA (68).

First recall on record: June 27, 2012. Most recent: December 24, 2025.

Risk classification: Class I: 25 · Class II: 38 · Class III: 5

Most recent recalls

DateAgencyProduct
December 24, 2025FDAAlinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20Z-0961-2026
April 30, 2025FDABrand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 S…Z-1652-2025
August 28, 2024FDAAlinity hq Analyzer, REF: 09P68-01Z-2681-2024
April 10, 2024FDAARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.Z-1476-2024
January 17, 2024FDAARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56…Z-0682-2024
January 17, 2024FDAAlinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully …Z-0680-2024
January 17, 2024FDAAlinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully …Z-0681-2024
January 3, 2024FDAAlinity ci-series System Control Module, REF: 03R70-01Z-0613-2024
November 15, 2023FDASimilac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets p…F-0328-2024
April 19, 2023FDAZone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wra…F-0698-2023
November 23, 2022FDASimilac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 coun…F-0158-2023
November 23, 2022FDASimilac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, …F-0156-2023
November 23, 2022FDASimilac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packag…F-0159-2023
November 23, 2022FDASimilac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose ab…F-0157-2023
November 23, 2022FDASimilac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count cartonF-0162-2023
November 23, 2022FDASimilac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged…F-0165-2023
November 23, 2022FDASimilac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a…F-0161-2023
November 23, 2022FDASimilac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count caseF-0160-2023
August 31, 2022FDAAbbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding conta…F-1575-2022
August 3, 2022FDAREF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL…Z-1456-2022
August 3, 2022FDAREF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, …Z-1454-2022
June 29, 2022FDAPedialyte with Immune Support***+Zinc/Selenium & Magnesium***Peach Mango Natural & Artifi…F-1343-2022
June 22, 2022FDAPedialyte***Replaces Electrolytes***Great for Kids and Adults***Strawberry Lemonade Natur…F-1312-2022
March 16, 2022FDAAbbott Similac Sensitive 34oz. plastic jar. 6 jars per case. Abbott Similac Sensitive I…F-0938-2022
March 16, 2022FDAAbbott Similac Organic with A2 Milk Toddler Drink 23.2oz plastic jar. 4 jars per case. A…F-0944-2022

Questions about this company

How many recalls does Abbott Laboratories have?
Recalert has 68 U.S. recalls on record for Abbott Laboratories, published between June 27, 2012 and December 24, 2025.
What was the most recent Abbott Laboratories recall?
FDA recall Z-0961-2026, published December 24, 2025: Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Which agencies have handled Abbott Laboratories recalls?
Abbott Laboratories appears as the recalling firm in recalls from: FDA (68).

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