PlainRecalls

Abbott Laboratories

Compiled from official public sources by the publisher.

124 recalls on record · Latest: Dec 24, 2025

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Agency notice ledger

Federal filing book Abbott Laboratories HEAVY-BOOK · MULTI-AGENCY

#128 of 14,151 · 124 notices · 0.119% archive

  • BOOK 124 notices
  • RANK #128 of 14,151
  • SHARE 0.119% archive
  • AGENCY FDA Food (61)
  • CAT medical devices
  • CATS 5 categories
  • LATEST Dec 24, 2025
  • PHOTO Pfizer Inc.

Nearest notice-volume peer: Pfizer Inc. (1 notice gap)

Abbott Laboratories accounts for about 0.119% of the 104,423-notice archive on 124 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Abbott Laboratories compares to 14,151 recalling firms

Abbott Laboratories ranks 128th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Abbott Laboratories vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

124 128th of 14151 higher than 14,023 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Abbott Laboratories in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Abbott Laboratories holds about 0.119% of archive notices alongside 124 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026

How the 124 notices break down

Same federal filing book as the hero total — split by issuing agency, no new counts.

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 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No
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: CELL-DYN Ruby Component: No
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: CELL-DYN Ruby Component: No
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: CELL-DYN Ruby Component: No
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: CELL-DYN Ruby
FDA Devices Moderate Apr 30, 2025

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
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 continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
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 access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c Processing Module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential
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 to perform automated chemistry tests, utilizing photometry and potentiometric technology.
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, automated hematology analyzer.
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 Food Moderate Nov 23, 2022

Similac Stage 1 (Export Colombia) 2 fl oz reclose able plastic bottle Packaged as: 48 count 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) Bottles 270 FL OZ (8L) Liter UPC: 7007462681 62681
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, DEXTROSE*** Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219-3034 USA
FDA Food Moderate Jun 29, 2022

Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Raspberry Lemonade Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT) 1L*** INGREDIENTS: WATER, DEXTROSE***Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219-3034 USA
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) PACKETS/NET WT. 3.6 OZ (102g)***INGREDIENTS: ANHYDROUSE DEXTROSE, CITRIC ACID, POTASSIUM CITRATE***Manufactured for: Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219
FDA Devices Moderate Apr 13, 2022

ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.
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-Advance 34oz. plastic jar. 6 jars per case. Item numbers: 53359 68084 5595776 6748701 Retail UPCs: 070074533605 070074680859 070074559582 070074122373
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 cans per case. Item numbers: 674845 6748406 6748408 6748412 6748425 6748426 6748430 6748453 6748484 Retail UPCs: 0070074122250 8699548994869 070074122311 0070074124131 070074122359 070074122274 070074123349 070074123325
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 055325002581
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 5459814 5459820 5459886 6771009 Retail UPCs: 70074545998 070074545998 055325545996 070074109404 070074103297 070074671833
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: 070074679280 070074680873
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. 23.2oz plastic jar. 6 jars per case. Item numbers: 68013 68092 5082178 Retail UPCs: 070074680156 070074680934 070074508221
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. 6 units per case. Item numbers: 68082 5753978 6748901 674891L Retail UPCs: 070074680835 070074575414 070074122380
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. Item numbers: 6208407 6208418 6208481 6208482 6208483 Retail UPCs: 070074110431 070074123905 070074110356 070074111834 070074110271
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 20.6oz. and 859g. plastic jar. 6 jars per case. Item numbers: 6499113 6698313 6818113 6818313 Retail UPCs: 055325000808 055325001645 055325002864 055325002888

Abbott Laboratories carries an outsized archive share

Food and dietary-supplement firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (124 here — heavy-book).

Pfizer Inc. 123 Philips North America 126 Lupin Pharmaceuticals Inc. 122 Subaru 122 Roche Diagnostics Operations, Inc. 127

Similar medical devices volume

Nearest multi-notice firms sharing this firm's wide category mix.

Philips North America 126 Roche Diagnostics Operations, Inc. 127 Assurance Infusion 118 Covidien, LP 131

Frequently Asked Questions

How many federal recall notices name Abbott Laboratories? ▼
PlainRecalls indexes 124 distinct federal recall events naming Abbott Laboratories, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Abbott Laboratories sit among other recalling firms? ▼
Abbott Laboratories ranks #128 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Abbott Laboratories's notices? ▼
FDA Food accounts for 61 of this firm's 124 indexed notices across 3 issuing agencies.
What product category dominates Abbott Laboratories's filing book? ▼
Filings for Abbott Laboratories span 5 product categories, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Abbott Laboratories: 124 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Food). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Abbott Laboratories; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026