Insights

Largest Product Recalls

The biggest product recalls on record by total units affected. Sorted from largest to smallest across CPSC, FDA, and USDA datasets.

480 recalls
High RiskFDA
Ajinomoto Foods North America Inc.
Item 5650233 Trader Joe's Vegetable Fried Rice, net wt. 1lb per bag. Retail bag UPC 00521482. Product packaging is flexible bags in a ma...
Produce·9,885,240 affected·Mar 3, 2026
CriticalFDA
Draeger, Inc.
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
Medical Devices·9,885,139 affected·Jun 16, 2025
High RiskFDA
B Braun Medical Inc
STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Mo...
Medical Devices·9,864,165 affected·Aug 15, 2024
High RiskFDA
Unomedical As
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm...
Diabetes Devices·9,782,880 affected·Nov 7, 2014
CriticalFDA
Adm Milling
Bulk flour
Food·9,697,409 affected·Sep 28, 2019
High RiskFDA
Lloyd Inc. Of Iowa
Lloyd Thyro-Tab 0.150 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the l...
Oral Drugs·9,575,108 affected·Apr 1, 2013
High RiskFDA
Becton Dickinson & Company
BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No. 367986
Medical Devices·9,568,900 affected·Feb 13, 2018
High RiskFDA
Becton Dickinson & Company
BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983
Medical Devices·9,568,900 affected·Feb 13, 2018
High RiskFDA
Lloyd Inc. Of Iowa
Lloyd Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the l...
Oral Drugs·9,545,718 affected·Apr 1, 2013
High RiskFDA
Abbott Point Of Care Inc.
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Medical Devices·9,067,050 affected·Aug 21, 2025
High RiskFDA
Abbott Point Of Care Inc.
i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge may be used for ...
Diabetes Devices·9,049,725 affected·Jan 15, 2020
High RiskFDA
Abbott Point Of Care Inc.
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Medical Devices·8,962,450 affected·Aug 21, 2025
High RiskFDA
Carefusion 213, Llc
SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0...
Drugs·8,960,000 affected·Mar 4, 2013
CriticalFDA
Coopersurgical, Inc.
Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646 To provide ...
Medical Devices·8,865,584 affected·Jan 26, 2015
High RiskFDA
Ultratab Laboratories, Inc.
DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Laboratories, Inc., Highland, ...
Oral Drugs·8,727,657 affected·Jan 26, 2022
High RiskFDA
Sanit Technologies, Llc Dba Durisan
Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net C...
Drugs·8,609,863 affected·Mar 10, 2021
CriticalFDA
Sanit Technologies, Llc Dba Durisan
Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net C...
Drugs·8,609,863 affected·Mar 10, 2021
High RiskFDA
Becton Dickinson & Company
BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematolo...
Medical Devices·8,494,000 affected·Aug 29, 2017
High RiskFDA
Oridion Medical 1987 Ltd.
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric,...
Medical Devices·8,435,772 affected·Feb 17, 2025
High RiskFDA
Medline Industries, Lp
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Medical Devices·8,267,150 affected·Sep 11, 2025
High RiskFDA
Vi-jon, Llc
Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Grape Flavor, 10 FL OZ (296 mL), a) Best Choice UPC 0 70038 66220 4 Proudly D...
Oral Drugs·8,064,834 affected·Jul 15, 2022
High RiskFDA
Carefusion 213, Llc
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10...
Drugs·7,990,100 affected·Mar 19, 2021
High RiskFDA
Ultratab Laboratories, Inc.
Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00
Oral Drugs·7,983,360 affected·Jan 26, 2022
CriticalFDA
United Dairymen Of Arizona
Low Heat Nonfat Dry Milk 25kg (EX25) Grade A
Dairy·7,941,025 affected·Mar 20, 2017
High RiskFDA
Innovagel
Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami,...
Oral Drugs·7,920,177 affected·Jan 5, 2017
High RiskFDA
Ultra Seal Corporation
Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH ...
Oral Drugs·7,858,690 affected·Jan 24, 2022
High RiskFDA
Perrigo Company Plc
Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma Solutions, 160 N Ph...
Drugs·7,775,813 affected·Sep 16, 2020
High RiskFDA
Teleflex Medical
Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Elcam Medical, Inc.
Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administrat...
Medical Devices·7,721,580 affected·Jul 19, 2015
High RiskFDA
Lloyd Inc. Of Iowa
Lloyd Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the l...
Oral Drugs·7,681,277 affected·Apr 1, 2013
High RiskFDA
Cardinal Health
AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599
Surgical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N
Medical Devices·7,659,634 affected·Jan 11, 2020