PlainRecalls

Abbott Laboratories

104 recalls on record · Latest: Dec 24, 2025

Abbott Laboratories Recall Insight

Abbott Laboratories appears on 104 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.124% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Dec 24, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 16 critical, 32 moderate, and 2 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 4 distinct product categories, with issuing agencies dominated by FDA Food (32), FDA Devices (18). The date window on this page runs from Mar 16, 2022 to Dec 24, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Dec 24, 2025

Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20

FDA Devices Moderate Nov 19, 2025

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 …

FDA Devices Moderate Apr 30, 2025

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description:…

FDA Devices Moderate Apr 30, 2025

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Description:…

FDA Devices Moderate Apr 30, 2025

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description:…

FDA Devices Moderate Apr 30, 2025

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description:…

FDA Devices Moderate Aug 28, 2024

Alinity hq Analyzer, REF: 09P68-01

FDA Devices Moderate Apr 10, 2024

ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.

FDA Devices Moderate Jan 17, 2024

Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuo…

FDA Devices Moderate Jan 17, 2024

Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous…

FDA Devices Moderate Jan 17, 2024

ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed…

FDA Devices Moderate Jan 3, 2024

Alinity ci-series System Control Module, REF: 03R70-01

FDA Devices Moderate Dec 27, 2023

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, au…

FDA Food Moderate Nov 15, 2023

Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.

FDA Food Moderate Apr 19, 2023

Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton

FDA Devices Low Jan 25, 2023

Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

FDA Food Moderate Nov 23, 2022

Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case

FDA Food Moderate Nov 23, 2022

Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case

FDA Food Moderate Nov 23, 2022

Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case

FDA Food Moderate Nov 23, 2022

Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kit

FDA Food Moderate Nov 23, 2022

Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 count case

FDA Food Moderate Nov 23, 2022

Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count carton

FDA Food Moderate Nov 23, 2022

Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case

FDA Food Moderate Nov 23, 2022

Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count carton

FDA Food Moderate Nov 23, 2022

Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose able plastic bottle Packaged as: 48 count case

FDA Food Moderate Nov 23, 2022

Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case

FDA Food Moderate Nov 23, 2022

Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case

FDA Devices Moderate Sep 7, 2022

ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27

FDA Food Moderate Aug 31, 2022

Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding container 1.5 Cal (for tube feeding) 1000 mL 8-33.8 FL OZ (1L) …

FDA Devices Moderate Aug 3, 2022

REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL

FDA Devices Moderate Aug 3, 2022

REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL

FDA Devices Moderate Aug 3, 2022

REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL

FDA Food Moderate Jun 29, 2022

Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Peach Mango Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT) 1L***INGREDIENTS: WATER, D…

FDA Food Low Jun 22, 2022

Pedialyte***Replaces Electrolytes***Great for Kids and Adults***Strawberry Lemonade Natural Flavor with Other Natural Flavor*** 6 0.6 OZ (17g) PACKET…

FDA Food Critical Mar 16, 2022

Abbott Similac Advance Infant Formula with Iron 12.4oz. can, 23.2oz. plastic jar, 20.6oz. plastic jar. 6 units per case. Abbott Similac Pro-Adva…

FDA Food Critical Mar 16, 2022

Abbott Alimentum, Abbott Similac Alimentum, Abbott Similac Alimentum HMO, Abbott Alimentum Similac, Abbott Similac Gold Alimentum HMO 400g can. 6 c…

FDA Food Critical Mar 16, 2022

Abbott Similac for Supplementation 22oz. plastic jar. 4 jars per case. Item numbers: 63013 Retail UPCs: 070074629506 70074629506

FDA Food Critical Mar 16, 2022

Abbott Similac Pro-Advance 23oz. and 34oz. plastic jar. 6 jars per case. Item numbers: 6720413 6721313 Retail UPCs: 055325002567 05532500…

FDA Food Critical Mar 16, 2022

Abbott Similac For Spit Up Infant Formula with Iron 22.5oz plastic jar. 6 jars per case. Item numbers: 5372976 Retail UPCs: 070074537306

FDA Food Critical Mar 16, 2022

Abbott Similac Human Milk Fortifier 0.9g Pouch / Sachet, 50 Pouch / Sachet per retail unit. 3 retail units per case Item numbers: 54598 5459813 …

FDA Food Critical Mar 16, 2022

Abbott Similac For Spit Up Infant Formula with Iron 7oz. can and 19.5oz. plastic jar. 6 units per case. Item numbers: 67927 68086 Retail UPCs…

FDA Food Critical Mar 16, 2022

Abbott Similac Organic 7oz. can. 6 cans per case. Abbott Similac Organic with A2 Milk Infant Formula with Iron 20.6oz. plastic jar. 4 jars per case.…

FDA Food Critical Mar 16, 2022

Abbott Similac Sensitive Infant Formula with Iron 22.5oz. plastic jar. 6 jars per case. Item numbers: 5081776 Retail UPCs: 070074508184

FDA Food Critical Mar 16, 2022

Abbott Similac Sensitive 34oz. plastic jar. 6 jars per case. Abbott Similac Sensitive Infant Formula with Iron 12.5oz. can and 20.1oz. plastic jar.…

FDA Food Critical Mar 16, 2022

Abbott Similac Alimentum Eye Q Plus 400g. can. Abbott Alimentum Eye Q 400g. can. Abbott Alimentum Eye Q Hypoallergenic 400g. can. 6 cans per case. …

FDA Food Critical Mar 16, 2022

Abbott Similac Advance Step-2 22.5oz. plastic jar. 6 jars per case. Abbott Similac Advance 34oz. can. 6 cans per case. Abbott Similac Pro-Advance …

FDA Food Critical Mar 16, 2022

Abbott Similac Pro-Advance 20.6oz., 30.3oz., 34oz., and 658g plastic jar. 6 jars per case. 7oz. can. 6 cans per case. Item numbers: 6720113 672…

FDA Food Critical Mar 16, 2022

Abbott Similac 360 Total Care Sensitive Infant Formula with Iron 7oz. can. 6 cans per case. 20.1oz. and 29.5oz. plastic jar. 4 jars per case. Item…

FDA Food Critical Mar 16, 2022

Abbott Similac Alimentum Allergies & Colic Hypoallergenic Infant Formula 400g. can. 6 cans per case. Item numbers: 5707713 Retail UPCs: 05…

FDA Food Critical Mar 16, 2022

Abbott Similac Advance Step-1 22oz. plastic jar and 34 oz. can. 6 units per case. Item numbers: 6499213 6698213 Retail UPCs: 055325000808 …

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds