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Abbott Laboratories FDA Recalls
86 recalls on file across devices, food, 41 of them Class I and 68 still open. Matched by name to ABT.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
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| Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20Class IINov 13, 2025Abbott Laboratories is recalling their Alinity ci-series Sys |
| Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.Class IISep 18, 2025Software issue for hq analyzer results in system not visibly |
| Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software vClass IIMar 18, 2025When expired reagents are scanned or manually entered, the s |
| Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software vClass IIMar 18, 2025When expired reagents are scanned or manually entered, the s |
| Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software vClass IIMar 18, 2025When expired reagents are scanned or manually entered, the s |
| Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software vClass IIMar 18, 2025When expired reagents are scanned or manually entered, the s |
| Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software vClass IIMar 18, 2025When expired reagents are scanned or manually entered, the s |
| Alinity hq Analyzer, REF: 09P68-01Class IIJun 14, 20241)If Complete Blood Count with differential and reticulocyte |
| ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.Class IIFeb 21, 2024The reason for the recall is the failure of calibration and |
| Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.Class IIOct 31, 2023Marketed towards preterm infants without approval as a new d |
| Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer Class IIOct 19, 2023The devices contain a dry natural rubber (latex) subcomponen |
| ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Class IIOct 19, 2023The devices contain a dry natural rubber (latex) subcomponen |
| Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number Class IIOct 19, 2023The devices contain a dry natural rubber (latex) subcomponen |
| Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer alClass IIOct 19, 2023The devices contain a dry natural rubber (latex) subcomponen |
| Alinity ci-series System Control Module, REF: 03R70-01Class IIMay 30, 2023There are potential performance issues found in the Alinity |
| Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard cartonClass IIMar 28, 2023Potential of foreign material (hard plastic) within product |
| Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction VesselsClass IIINov 24, 2022Reaction vessels may contain a potential contaminant that co |
| Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count cartonClass IIOct 13, 2022Compromised seal integrity which could lead to spoilage |
| Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count caseClass IIOct 13, 2022Compromised seal integrity which could lead to spoilage |
| Similac Stage 1 (Export Colombia) 2 fl oz reclose able plastic bottle Packaged as: 48 count caseClass IIOct 13, 2022Compromised seal integrity which could lead to spoilage |
| Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose able plastic bottle Packaged as: 48 count caseClass IIOct 13, 2022Compromised seal integrity which could lead to spoilage |
| Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count cartonClass IIOct 13, 2022Compromised seal integrity which could lead to spoilage |
| Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count caseClass IIOct 13, 2022Compromised seal integrity which could lead to spoilage |
| Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a caseClass IIOct 13, 2022Compromised seal integrity which could lead to spoilage |
| Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as:Class IIOct 13, 2022Compromised seal integrity which could lead to spoilage |
| Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count caseClass IIOct 13, 2022Compromised seal integrity which could lead to spoilage |
| Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 cClass IIOct 13, 2022Compromised seal integrity which could lead to spoilage |
| Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count caseClass IIOct 13, 2022Compromised seal integrity which could lead to spoilage |
| Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 count caseClass IIOct 13, 2022Compromised seal integrity which could lead to spoilage |
| ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27Class IIJul 26, 2022One lot of reagent was manufactured with insufficient quanti |
| Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding container 1.5 Cal (for tube feeding)Class IIJul 3, 2022Potential leaking/pinholes in bottle |
| 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 mLClass IIJun 9, 2022There is a potential for falsely elevated Hemoglobin %A1c an |
| 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 mLClass IIJun 9, 2022There is a potential for falsely elevated Hemoglobin %A1c an |
| 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 mLClass IIJun 9, 2022There is a potential for falsely elevated Hemoglobin %A1c an |
| Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Raspberry Lemonade Natural & Artificial Flavor, 33.8 FL OZ Class IIJun 3, 2022These products are being recalled due to the potential of le |
| Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Peach Mango Natural & Artificial Flavor, 33.8 FL OZ (1.05 QClass IIJun 3, 2022These products are being recalled due to the potential of le |
| Pedialyte***Replaces Electrolytes***Great for Kids and Adults***Strawberry Lemonade Natural Flavor with Other Natural FlClass IIIJun 3, 2022The third party contract manufacturer used a dextrose ingred |
| ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration ofClass IIMar 8, 2022This calibrator lot did not meet acceptance criteria during |
| Abbott Similac For Spit Up Infant Formula with Iron 12.5oz. can. 6 cans per case. Item numbers: 5095976 Retail UPClass IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott EleCare Jr Amino Acid-Based Nutrition Powder Chocolate 14.1oz. can. 6 cans per case. Item numbers: 66273 Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott EleCare Amino Acid-Based Powder Infant Formula with Iron 14.1oz. can, Abbott Elecare 400g. can, Abbott Elecare UnClass IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac EleCare HMO, Abbott Similac EleCare, Abbott EleCare Similac Gold, Abbott EleCare Similac 400g can. 6 cansClass IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Sensitive 34oz. plastic jar. 6 jars per case. Abbott Similac Sensitive Infant Formula with Iron 12.5oz.Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Sensitive Lactose Sensitivity 22oz. plastic jar. 6 jars per case. Item numbers: 6499813 Retail UPClass IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Infant Formula Powder 12.6oz. can. 6 cans per case. Item numbers: Clinical Retail UPCs: N/A - ClinicalClass IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Total Comfort 638g. plastic jar and 8oz. can. 6 units per case. Abbott Similac Advance Step-2 34oz. canClass IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Advance Step-2 22.5oz. plastic jar. 6 jars per case. Abbott Similac Advance 34oz. can. 6 cans per case.Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Alimentum Allergies & Colic Hypoallergenic Infant Formula 400g. can. 6 cans per case. Item numbers: Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Alimentum 400g. can. 6 cans per case. Item numbers: 5705806 Retail UPCs: 8699548994869Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Advance Step-1 22oz. plastic jar and 34 oz. can. 6 units per case. Item numbers: 6499213 6698213 Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Advance Infant Formula with Iron 12.4oz. can, 23.2oz. plastic jar, 20.6oz. plastic jar. 6 units per case.Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac For Spit Up Infant Formula with Iron 22.5oz plastic jar. 6 jars per case. Item numbers: 5372976 RClass IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Sensitive Infant Formula with Iron 22.5oz. plastic jar. 6 jars per case. Item numbers: 5081776 ReClass IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Alimentum Eye Q Plus 400g. can. Abbott Alimentum Eye Q 400g. can. Abbott Alimentum Eye Q Hypoallergenic 4Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Pro-Advance 20.6oz., 30.3oz., 34oz., and 658g plastic jar. 6 jars per case. 7oz. can. 6 cans per case. Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac 360 Total Care Infant Formula with Iron 20.6oz. and 30.3oz. palstic jar. 4 jars per case. 7oz. can. 6 canClass IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Total Comfort Infant Formula with Iron 12.6oz. can. 6 cans per case. Item numbers: 62599 Retail UPClass IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Alimentum with 2'-FL HMO, Abbott Similac Alimentum HMO, Abbott Alimentum HMO, Abbott Similac Alimentum inClass IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott EleCare Junior Vanilla 14.1oz. can and Abbott EleCare Jr Similac Vanilla 14.1oz. can. 6 cans per case. Item Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott EleCare Jr Amino Acid-Based Nutrition Powder Banana 14.1oz. can. 6 cans per case. Item numbers: 66275 ReClass IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott EleCare, EleCare LCP Hypoallergenic, Similac EleCare 400g. can. 6 cans per case. Item numbers: 5351034 5351Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Total Comfort 12.6oz. can. 6 cans per case. Item numbers: 6259962 Retail UPCs: 070074119953Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Organic with A2 Milk Infant Formula with Iron 8oz. and 7oz. can. 6 cans per case. 20.6oz. plastic jar. 4Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac PM 60/40 Low Iron Infant Formula, 14.1oz. can. 6 cans per case. Item numbers: 00850 Retail UPCs: Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott EleCare Jr Amino Acid-Based Nutrition Powder Unflavored 14.1oz. can. 6 cans per case. Item numbers: 55253 Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Alimentum Infant Formula with Iron 12oz. can. 6 jars per case; 19.8oz. can. 4 cans per case; 7oz. can. 6Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott EleCare Infant Formula Unflavoured 400g can. 6 cans per case. Item number 5466539 Retail unit UPC 07007410459Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Pro-Advance Infant Formula with Iron 20.6oz. and 23.2oz. plastic jar. 4 jars per case; 34oz. plastic jar.Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Pro-Sensitive Infant Formula with Iron 20.1oz. and 22.5oz. plastic jar. 4 jars per case; 34oz. plastic jaClass IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Organic 7oz. can. 6 cans per case. Abbott Similac Organic with A2 Milk Infant Formula with Iron 20.6oz. Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Pro-Total Comfort Infant Formula with Iron 20.1oz. and 22.5oz. plastic jar. 4 jars per case. 34oz. plastiClass IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Alimentum Toddler Drink 12.1oz. can. 6 cans per case. Item numbers: 68398 Retail UPCs: 07007468Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Alimentum, Abbott Similac Alimentum, Abbott Similac Alimentum HMO, Abbott Alimentum Similac, Abbott Similac GoldClass IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Pro-Advance 23oz. and 34oz. plastic jar. 6 jars per case. Item numbers: 6720413 6721313 Retail UClass IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Organic with A2 Milk Toddler Drink 23.2oz plastic jar. 4 jars per case. Abbott Similac Organic Toddler wClass IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac 360 Total Care Sensitive Infant Formula with Iron 7oz. can. 6 cans per case. 20.1oz. and 29.5oz. plastic Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac for Supplementation 22oz. plastic jar. 4 jars per case. Item numbers: 63013 Retail UPCs: 070074Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac Human Milk Fortifier 0.9g Pouch / Sachet, 50 Pouch / Sachet per retail unit. 3 retail units per case IClass IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| Abbott Similac For Spit Up Infant Formula with Iron 7oz. can and 19.5oz. plastic jar. 6 units per case. Item numbers:Class IFeb 17, 2022Consumer complaints related to Cronobacter sakazakii or Salm |
| ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 andClass IISep 29, 2021Twelve software-related issues affecting software version 9. |
| ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-0Class IISep 29, 2021Twelve software-related issues affecting software version 9. |
| Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model Class IIJul 26, 2021Due to potential performance issues with software version 3. |
| REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866Class IIJun 10, 2021There is a potential for >10% under-recovery on Activated Al |
| REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866Class IIJun 10, 2021There is a potential for >10% under-recovery on Activated Al |
| REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859Class IIJun 10, 2021There is a potential for >10% under-recovery on Activated Al |
| REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine AminotransfeClass IIJun 10, 2021There is a potential for 15% under-recovery on Activated Ala |