Abbott Laboratories recalls
Every recall we track for Abbott Laboratories — 111 in all, from 2012–2025 — plus the complaints and injury reports the public filed about them. 39 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Abbott Laboratories more than tripled in 2025 (7, up from 2 in 2024). 37% rated “stop using now”.
All FDA recall records for Abbott Laboratories since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 15 | 0 | 15 |
| 2020 | 0 | 0 | 1 | 3 | 4 |
| 2021 | 0 | 0 | 7 | 0 | 7 |
| 2022 | 39 | 2 | 20 | 2 | 63 |
| 2023 | 0 | 0 | 7 | 0 | 7 |
| 2024 | 0 | 0 | 2 | 0 | 2 |
| 2025 | 0 | 0 | 7 | 0 | 7 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Abbott Laboratories recalls before 2017
Recalls on record by year.
Most common reasons for Abbott Laboratories recalls
What to do if you have a recalled Abbott Laboratories product
- Match the lot code, UPC and best-by date on your package to the recall; only those lots are affected.
- Don’t eat it. Return it for a refund or throw it away sealed, and clean surfaces it touched.
- If you feel unwell after eating it, call your doctor and mention the recall.
All Abbott Laboratories recalls
34 shown- Lower riskMedical device
Abbott Laboratories recalls Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Abbott Laboratories is a global leader in medical devices, diagnostics, and healthcare products. We provide innovative solutions for healthcare professionals and patients worldwide.
Abbott LaboratoriesNov 13, 2025 - Lower riskMedical device
Abbott Laboratories recalls Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0
Abbott recalls Alinity hq Analyzer models 09P68-01 software versions 5.0 to 5.10.1 (US) and 5.7 to 5.10.1 (OUS) due to potential incorrect results when saturation occurs. Affected units may need software update.
AbbottSep 18, 2025 - Lower riskMedical device
Abbott Laboratories recalls Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software
Abbott recalls CELL-DYN Ruby analyzers with model 08H67-01 software. Expired reagents scanned or manually entered may change expiration dates to current or future dates without warning, violating operator guidelines.
Abbott LaboratoriesMar 18, 2025 - Lower riskMedical device
Abbott Laboratories recalls Alinity hq Analyzer, REF: 09P68-01
Abbott recalls Alinity hq Analyzer (REF: 09P68-01) with software versions 5.7 (US) and 5.6 and below (OUS) due to potential false low red blood cell count results when running specific blood tests in sequence.
AbbottJun 14, 2024 - Lower riskMedical device
Abbott Laboratories recalls ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Abbott recalls ARCHITECT STAT Myoglobin Reagent Kits with specific lot numbers due to potential incorrect myoglobin test results, risking delayed heart attack diagnosis.
AbbottFeb 21, 2024 - Lower riskFood
Abbott Laboratories recalls Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
Abbott recalls Similac Probiotic Tri-Blend foil packets for preterm infants due to unsafe marketing and food additive concerns. Learn about affected products and safety steps.
AbbottOct 31, 2023 - Lower riskMedical device
Abbott Laboratories recalls Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number
Abbott recalls two blood analyzers due to unlabeled natural rubber latex in components. Affected models include CD-Ruby and CD Sapphire with specific serial numbers. Consumers should check their devices for latex content.
AbbottOct 19, 2023 - Lower riskMedical device
Abbott Laboratories recalls Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer
Abbott recalls Alinity i Processing Module REF 03R65-01 due to dry natural rubber (latex) subcomponent not being labeled. Affected units have specific serial numbers listed in the recall notice.
AbbottOct 19, 2023 - Lower riskMedical device
Abbott Laboratories recalls Alinity ci-series System Control Module, REF: 03R70-01
Abbott recalls Alinity ci-series System Control Module software versions 3.4.0 and lower due to potential erroneous test results. Affected users should check their software version and contact Abbott for updates.
AbbottMay 30, 2023 - Lower riskFood
Abbott Laboratories recalls Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton
Abbott recalls Zone Perfect Fudge Graham bars due to potential hard plastic foreign material. Consumers should check lot numbers on packaging for affected items.
Abbott LaboratoriesMar 28, 2023 - Lower riskMedical device
Abbott Laboratories recalls Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Abbott recalls Alinity Reaction Vessels (REF: 06P1401) for use with Alinity i Systems and ARCHITECT systems due to potential contaminant affecting optical performance. No remedy specified in recall notice.
AbbottNov 24, 2022 - Use cautionFood
Abbott Laboratories recalls Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
Abbott Laboratories recalls Similac 360 Total Care 2 fl oz bottles due to compromised seals that may cause spoilage. Check batch numbers and best-by dates.
SimilacOct 13, 2022 - Lower riskMedical device
Abbott Laboratories recalls ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Abbott recalls ARCHITECT STAT Tropon: Reagent Kit REF 2K41-27 with insufficient heterophilic blocking agents. Stop using if you have the specific lot number.
AbbottJul 26, 2022 - Use cautionFood
Abbott Laboratories recalls Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding container 1.5 Cal (for tube
Abbott recalls 1000mL Jevity feeding bottles due to potential leaks. This could cause spills or contamination in tube feeding. Consumers should check product details and contact Abbott for guidance.
AbbottJul 3, 2022 - Lower riskMedical device
Abbott Laboratories recalls 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
Abbott recalls Alinity c Hemoglobin Reagent Kit (REF: 08P4377) due to potential false high A1c results. Affected units include specific lot numbers and sizes. Consumers should contact Abbott for details.
AbbottJun 9, 2022 - Lower riskFood
Abbott Laboratories recalls Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Peach Mango Natural & Artificial Flavor, 33.8 FL OZ (1.05
Abbott recalls Pedialyte with Immune Support due to potential leakage from the 1L container. This may cause spills or contamination. Consumers should check product codes and contact Abbott for details.
AbbottJun 3, 2022 - Lower riskFood
Abbott Laboratories recalls Pedialyte***Replaces Electrolytes***Great for Kids and Adults***Strawberry Lemonade Natural Flavor with Other Natural
Abbott recalls Pedialyte Strawberry Lemonade powder due to unlabeled wheat-derived dextrose in one lot. This may cause allergic reactions for those with wheat allergies. Consumers should check product codes and contact Abbott for details.
AbbottJun 3, 2022 - Lower riskMedical device
Abbott Laboratories recalls ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of
Abbott recalls ARCHITECT STAT Myoglobin Calibrators (RES 2K4:01) due to potential calibration errors. Controls may exceed specified ranges if used with this lot, affecting test accuracy.
AbbottMar 8, 2022 - Stop using nowFood
Abbott Laboratories recalls Abbott Similac Advance Infant Formula with Iron 12.4oz. can, 23.2oz. plastic jar, 20.6oz. plastic jar. 6 units per
Abbott recalls Similac Advance infant formula with iron due to Cronobacter sakazakii contamination risks in infants. 12.4oz cans and 23.2oz jars affected.
AbbottFeb 17, 2022 - Lower riskMedical device
Abbott Laboratories recalls ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17
Abbott recalls ARCHITECT i1000SR, i2000SR, and i2000 analyzers with software version 9.41 and earlier due to software issues that may cause inaccurate test results for cardiac, metabolic, and other analytes.
AbbottSep 29, 2021 - Lower riskMedical device
Abbott Laboratories recalls Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model
Abbott recalls Alinity ci-series System Control Module units with software versions 3.2.3 and earlier due to potential performance issues including incorrect reagent status displays, damaged connectors, and sample processing errors. Affected units have specific serial numbers and model numbers.
AbbottJul 26, 2021 - Lower riskMedical device
Abbott Laboratories recalls REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866
Abbott recalls specific Activated Alanine Aminotransferase test kits for potential incorrect patient results due to under-recovery in high sample concentrations. Affected lots may cause inaccurate bilirubin results.
AbbottJun 10, 2021 - Lower riskMedical device
Abbott Laboratories recalls Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system
Abbott recalls Accelerator APS Aliquoter Module (List 07L40) due to potential sample dilution from AQM clot detection errors, which could cause incorrect lab results. Affected units include all field serial numbers.
AbbottApr 2, 2020 - UnratedMedical device
Abbott Laboratories recalls ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal
Abbott recalls ARCHITECT C Peptide Calibrators due to Mexico license renewal documentation error. All units until new license is obtained are affected. No immediate action needed.
AbbottApr 1, 2020 - Lower riskFood
Abbott Laboratories recalls Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a 13.2 oz. can, with 6 cans per case.
Abbott recalls low-calcium vitamin D-free infant formula with iron powder in 13.2 oz cans due to off-color and odor from compromised can seams.
Abbott LaboratoriesSep 13, 2019 - Lower riskMedical device
Abbott Laboratories recalls ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem
Abbott recalls ARCHITECT BNP Calibrators due to stability drift causing inaccurate BNP test results. Affected units include specific lot numbers from July 2019 to January 2020. Consumers should contact Abbott for details.
AbbottMay 24, 2019 - Lower riskMedical device
Abbott Laboratories recalls "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use
Abbott recalls HbA1c calibrators that may have incorrect manufacturing, risking inaccurate blood sugar test results outside a specific concentration range. Affected units may need replacement to ensure accurate diabetes monitoring.
AbbottMay 22, 2019 - Lower riskMedical device
Abbott Laboratories recalls Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm
Abbott recalls Emerald Diluent Tubing (lot 2018-10-16) that may show cloudiness or powder, leading to false high platelet counts in blood tests. Affected units include specific instrument serial numbers.
AbbottMay 9, 2019 - Lower riskMedical device
Abbott Laboratories recalls ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the
Abbott recalls ARCHITECT Intact PTH Calibrators due to delivery without required dry ice. This affects lab equipment used for measuring intact PTH in blood tests.
AbbottApr 9, 2019 - Lower riskMedical device
Abbott Laboratories recalls CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro
Abbott recalls CELL-DYN Emerald analyzers with serial numbers below 7765 due to potential QC low results for RBC and PLT. Affected units may need correction to avoid inaccurate blood tests.
AbbottFeb 20, 2019 - Use cautionFood
Abbott Laboratories recalls Similac¿ Advance Complete Nutrition Infant Formula with Iron, 1.45lb plastic container.
Abbott Laboratories recalls Similac Advance Complete Nutrition Infant Formula due to incorrect Chinese labeling on containers distributed in the US.
SimilacJan 28, 2015 - Use cautionDrug
Abbott Laboratories recalls Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT
Abbott Laboratories recalled Synthroid 150 mcg tablets because the label declared 150 mcg but the product actually contained 75 mcg tablets.
AbbottDec 4, 2012 - Use cautionDrug
Abbott Laboratories recalls Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL
Abbott recalls Synthroid 112 mcg tablets due to a thin wall defect in the bottle bottom that may affect tablet stability.
Abbott LaboratoriesJul 19, 2012 - Use cautionDrug
Abbott Laboratories recalls Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira,
Abbott Laboratories recalls specific lots of Zemplar (paricalcitol) Injection due to CGMP deviations involving potentially incorrect vial stoppers.
Abbott LaboratoriesMay 14, 2012
Abbott Laboratories recall questions
How many recalls has Abbott Laboratories had?
111 recalls from Abbott Laboratories are on record with U.S. safety agencies, from 2012–2025 (61 food, 45 medical device, 5 drug).
What is the most recent Abbott Laboratories recall?
Abbott Laboratories recalls Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20, dated Nov 13, 2025. Every Abbott Laboratories recall is listed on this page, newest first.
Why are Abbott Laboratories products recalled?
The most common reasons on record: Compromised seal integrity which could lead to spoilage (12); Devices were delivered without the required dry ice. (9).
What should I do if I have a recalled Abbott Laboratories product?
Match the lot code, UPC and best-by date on your package to the recall; only those lots are affected. Don’t eat it. Return it for a refund or throw it away sealed, and clean surfaces it touched. If you feel unwell after eating it, call your doctor and mention the recall.
How do I get alerts for new Abbott Laboratories recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.