PlainRecalls

Abbott Laboratories

Compiled from official public sources by the publisher.

124 recalls on record · Latest: Dec 24, 2025

Subscribe to new Abbott Laboratories recalls (RSS)

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 Low May 22, 2019

Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
FDA Devices Low May 22, 2019

ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood.
FDA Devices Low May 22, 2019

ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood.
FDA Devices Low May 22, 2019

ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.
FDA Devices Moderate Apr 10, 2019

CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.
FDA Devices Moderate Jun 28, 2017

ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in the diagnosis of androgen disorders.
FDA Devices Moderate Mar 15, 2017

CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories
FDA Devices Moderate Nov 16, 2016

ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
FDA Devices Moderate Jun 8, 2016

The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
FDA Devices Moderate Apr 27, 2016

CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. The CELL-DYN Emerald Cleaner is an enzymatic cleaner used to clean the measurement system and the fluidics.
FDA Devices Moderate Jul 29, 2015

ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology.
FDA Devices Moderate Jul 8, 2015

ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
FDA Devices Moderate Jun 17, 2015

Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is shipped ready to use.
FDA Food Moderate Mar 18, 2015

Similac¿ Advance Complete Nutrition Infant Formula with Iron, 1.45lb plastic container.
FDA Devices Moderate Nov 5, 2014

HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to lyophilization, the calibrator matrix is an MES-buffered solution. Preservative: Ofloxacin. For use in the calibration of the Hemoglobin A1c assay on the ARCHITECT c 8000 and c 4000 Systems.
FDA Devices Moderate Jun 4, 2014

ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. Product Usage: The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human s
FDA Devices Moderate Jun 4, 2014

ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. Product Usage: The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.
FDA Devices Moderate Jan 30, 2013

Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); in vitro diagnostic.
FDA Drug Moderate Jan 9, 2013

Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A.
FDA Drug Moderate Oct 3, 2012

Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-9296-90
FDA Drug Moderate Oct 3, 2012

Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-5182-90.
FDA Drug Moderate Oct 3, 2012

Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-4552-90.
FDA Devices Moderate Jul 4, 2012

ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical m
FDA Drug Moderate Jun 27, 2012

Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott Laboratories, North Chicago, IL 60064, USA, NDC 0074-1658-05

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