Brand
Abbott Laboratories Recalls
99 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Abbott Laboratories.
99Total Recalls
36Critical
174.8MUnits Affected
Nov 13, 2025Most Recent
All Recalls
Every Abbott Laboratories Recall
Sorted by most recent. Click any recall for full details.
99 recalls
High RiskFDA
Abbott Laboratories
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Medical Devices11,653 affectedNov 13, 2025
High RiskFDA
Abbott Laboratories
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for O...
Medical Devices833 affectedSep 18, 2025
High RiskFDA
Abbott Laboratories
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product ...
Medical Devices2,947 affectedMar 18, 2025
High RiskFDA
Abbott Laboratories
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product ...
Medical Devices19 affectedMar 18, 2025
High RiskFDA
Abbott Laboratories
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product ...
Medical Devices1 affectedMar 18, 2025
High RiskFDA
Abbott Laboratories
Alinity hq Analyzer, REF: 09P68-01
Medical Devices816 affectedJun 14, 2024
High RiskFDA
Abbott Laboratories
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Diagnostic Devices7,482 affectedFeb 21, 2024
High RiskFDA
Abbott Laboratories
Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
Food226,650 affectedOct 31, 2023
High RiskFDA
Abbott Laboratories
Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random ...
Diagnostic Devices1,325 affectedOct 19, 2023
High RiskFDA
Abbott Laboratories
Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random an...
Diagnostic Devices1,127 affectedOct 19, 2023
High RiskFDA
Abbott Laboratories
Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-p...
Medical Devices670 affectedOct 19, 2023
High RiskFDA
Abbott Laboratories
ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module...
Medical Devices995 affectedOct 19, 2023
High RiskFDA
Abbott Laboratories
Alinity ci-series System Control Module, REF: 03R70-01
Medical Devices8,424 affectedMay 30, 2023
High RiskFDA
Abbott Laboratories
Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton
Food646,668 affectedMar 28, 2023
RecallFDA
Abbott Laboratories
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Medical Devices70 affectedNov 24, 2022
High RiskFDA
Abbott Laboratories
Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
Food14,588,544 affectedOct 13, 2022
High RiskFDA
Abbott Laboratories
Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case
Food14,588,544 affectedOct 13, 2022
High RiskFDA
Abbott Laboratories
Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
Food15,865,104 affectedOct 13, 2022
High RiskFDA
Abbott Laboratories
Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kit
Food14,588,544 affectedOct 13, 2022
High RiskFDA
Abbott Laboratories
Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 count case
Food14,588,544 affectedOct 13, 2022
High RiskFDA
Abbott Laboratories
Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count carton
Food14,588,544 affectedOct 13, 2022
High RiskFDA
Abbott Laboratories
Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
Beverages14,588,544 affectedOct 13, 2022
High RiskFDA
Abbott Laboratories
Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count carton
Food14,588,544 affectedOct 13, 2022
High RiskFDA
Abbott Laboratories
Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
Food14,588,544 affectedOct 13, 2022
High RiskFDA
Abbott Laboratories
Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case
Food14,588,544 affectedOct 13, 2022
High RiskFDA
Abbott Laboratories
Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case
Food14,588,544 affectedOct 13, 2022
High RiskFDA
Abbott Laboratories
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Diagnostic Devices2,451 affectedJul 26, 2022
High RiskFDA
Abbott Laboratories
Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding container 1.5 Cal (for tube feeding) 1000 mL 8-33.8...
Food179 affectedJul 3, 2022
High RiskFDA
Abbott Laboratories
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
Diagnostic Devices64 affectedJun 9, 2022
High RiskFDA
Abbott Laboratories
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
Medical Devices103,316 affectedJun 9, 2022
High RiskFDA
Abbott Laboratories
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
Diagnostic Devices7,391 affectedJun 9, 2022
RecallFDA
Abbott Laboratories
Pedialyte***Replaces Electrolytes***Great for Kids and Adults***Strawberry Lemonade Natural Flavor with Other Natural Flavor*** 6 0.6 OZ ...
Produce789 affectedJun 3, 2022
High RiskFDA
Abbott Laboratories
Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Peach Mango Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT) 1L***INGREDIEN...
Beverages50,502 affectedJun 3, 2022
CriticalFDA
Abbott Laboratories
Abbott Similac Advance Infant Formula with Iron 12.4oz. can, 23.2oz. plastic jar, 20.6oz. plastic jar. 6 units per case. Abbott Simi...
Baby Food & Formula3,491,684 affectedFeb 17, 2022
CriticalFDA
Abbott Laboratories
Abbott Alimentum, Abbott Similac Alimentum, Abbott Similac Alimentum HMO, Abbott Alimentum Similac, Abbott Similac Gold Alimentum HMO 40...
Food209,857 affectedFeb 17, 2022
CriticalFDA
Abbott Laboratories
Abbott Similac for Supplementation 22oz. plastic jar. 4 jars per case. Item numbers: 63013 Retail UPCs: 070074629506 70074629506
Supplements22,074 affectedFeb 17, 2022
CriticalFDA
Abbott Laboratories
Abbott Similac Pro-Advance 23oz. and 34oz. plastic jar. 6 jars per case. Item numbers: 6720413 6721313 Retail UPCs: 0553250025...
Food26,035 affectedFeb 17, 2022
CriticalFDA
Abbott Laboratories
Abbott Similac For Spit Up Infant Formula with Iron 22.5oz plastic jar. 6 jars per case. Item numbers: 5372976 Retail UPCs: 070...
Baby Food & Formula21,126 affectedFeb 17, 2022
CriticalFDA
Abbott Laboratories
Abbott Similac Human Milk Fortifier 0.9g Pouch / Sachet, 50 Pouch / Sachet per retail unit. 3 retail units per case Item numbers: 545...
Dairy104,146 affectedFeb 17, 2022
CriticalFDA
Abbott Laboratories
Abbott Similac For Spit Up Infant Formula with Iron 7oz. can and 19.5oz. plastic jar. 6 units per case. Item numbers: 67927 68086 ...
Baby Food & Formula138,075 affectedFeb 17, 2022
CriticalFDA
Abbott Laboratories
Abbott Similac Organic 7oz. can. 6 cans per case. Abbott Similac Organic with A2 Milk Infant Formula with Iron 20.6oz. plastic jar. 4 ja...
Dairy52,663 affectedFeb 17, 2022
CriticalFDA
Abbott Laboratories
Abbott Similac Sensitive Infant Formula with Iron 22.5oz. plastic jar. 6 jars per case. Item numbers: 5081776 Retail UPCs: 0700...
Baby Food & Formula46,757 affectedFeb 17, 2022
CriticalFDA
Abbott Laboratories
Abbott Similac Sensitive 34oz. plastic jar. 6 jars per case. Abbott Similac Sensitive Infant Formula with Iron 12.5oz. can and 20.1oz. ...
Baby Food & Formula2,046,814 affectedFeb 17, 2022
CriticalFDA
Abbott Laboratories
Abbott Similac Alimentum Eye Q Plus 400g. can. Abbott Alimentum Eye Q 400g. can. Abbott Alimentum Eye Q Hypoallergenic 400g. can. 6 cans...
Food40,943 affectedFeb 17, 2022
CriticalFDA
Abbott Laboratories
Abbott Similac Advance Step-2 22.5oz. plastic jar. 6 jars per case. Abbott Similac Advance 34oz. can. 6 cans per case. Abbott Similac ...
Food103,025 affectedFeb 17, 2022
CriticalFDA
Abbott Laboratories
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: ...
Food135,652 affectedFeb 17, 2022
CriticalFDA
Abbott Laboratories
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 c...
Baby Food & Formula227,970 affectedFeb 17, 2022
CriticalFDA
Abbott Laboratories
Abbott Similac Alimentum Allergies & Colic Hypoallergenic Infant Formula 400g. can. 6 cans per case. Item numbers: 5707713 Retai...
Baby Food & Formula45,223 affectedFeb 17, 2022