Abbott Laboratories
104 recalls on record · Latest: Dec 24, 2025
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