Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

6101–6125 of 52958

HighFDA (Devices)·Z-0583-2025·2024-12-11
Spectral CT Devices Pose Collision and Misdiagnosis Software Risks
Philips Spectral CT and Spectral CT Plus devices may fail to update plan positioning during interventional procedures, creating collision risks to operators and patients. A software defect may also assign incorrect patient IDs, potentially causing misdiagnosis.
Product
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0252-2025·2024-12-11
Jose Madrid Salsa Recalled for Undeclared Yellow Food Colorants
Jose Madrid Salsa Chipotle Con Queso is being recalled because it contains undeclared Yellow #5 and Yellow #6 food colorants. These additives must be labeled and can trigger sensitivities in some consumers.
Product
Jose Madrid Salsa Chipotle Con Queso, Net Wt. 13 oz. (369g), packaged in glass jars; 12 jars per case
Category
Food
Distribution
16 states
HighFDA (Food)·F-0243-2025·2024-12-11
Member's Mark Roasted Red Pepper Hummus Recalled for Potential Foreign Objects
Cedar's Mediterranean Foods is recalling Member's Mark Roasted Red Pepper Hummus due to potential presence of foreign objects. The recall affects 23,136 units distributed to retail locations in ten states.
Product
Member's Mark brand Roasted Red Pepper Hummus; 32 oz (907 g) Plastic Container with UPC# 193968044268
Category
Food
Distribution
10 states
HighFDA (Devices)·Z-0597-2025·2024-12-11
Siemens Atellica CI Analyzer may produce falsely elevated electrolyte test results
Siemens' Atellica CI Analyzer may display incorrect diluent volume levels, causing falsely elevated sodium, potassium, and chloride test results in 559 units distributed worldwide.
Product
Atellica CI Analyzer. Catalog Numbers: 10947347.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0607-2025·2024-12-11
GE Healthcare CT Imaging System May Produce Rotated Medical Images
GE Healthcare CT systems may produce progressively rotated images during helical, cine, and cardiac scans. The issue affects 4 units worldwide and can cause rotations up to 56 degrees.
Product
GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0078-2025·2024-12-11
Prescription Cinacalcet Tablets Recalled for N-Nitroso Impurity
Aurobindo Pharma USA Inc is recalling Cinacalcet 60mg tablets nationwide due to N-nitroso Cinacalcet impurity exceeding FDA recommended interim limits.
Product
Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0093-2025·2024-12-11
Diltiazem Hydrochloride Capsules Recalled Due to Manufacturing Impurity
Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride Extended-Release Capsules (60 mg) due to presence of N-nitroso-Desmethyl-Diltiazem impurity exceeding FDA limits. Approximately 34,848 bottles nationwide are affected.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0236-2025·2024-12-11
Fruit Punch Recalled Due to Metal Fragment Contamination Risk
Sysco Fruit Punch 24-ounce products are recalled due to metal fragments introduced during dextrose production. Consumers should not consume the affected product and contact their retailer for refund or replacement.
Product
SYSCO FRUIT PUNCH, NET WT. 24OZ, Case UPC 10074865093221, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
Category
Food
Distribution
30 states
HighFDA (Drugs)·D-0091-2025·2024-12-11
Genuine Joe Antibacterial Lotion Soap recalled for manufacturing quality issue
Midlab Incorporated is recalling Genuine Joe Antibacterial Lotion Soap (Lot 0711241) nationwide due to out-of-specification microbial test results found during manufacturing quality checks.
Product
Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, GA 30339
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0099-2025·2024-12-11
Duloxetine Delayed-Release Capsules Recalled Due to Manufacturing Quality Deviation
Amerisource Health Services LLC recalls Duloxetine 20 mg delayed-release capsules due to the presence of N-nitroso-duloxetine impurity above acceptable limits. The affected bottles were distributed in Pennsylvania, Ohio, and Puerto Rico.
Product
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06
Category
Drug
Distribution
3 states
HighFDA (Drugs)·D-0079-2025·2024-12-11
Cinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding FDA Safety Limit
Aurobindo Pharma USA recalls Cinacalcet 90 mg tablets nationwide due to N-nitroso impurity exceeding FDA's interim safety limit. The impurity is a known carcinogenic compound.
Product
Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 658
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0626-2025·2024-12-11
Medline recalls surgical convenience kits with defective smoke evacuation component
Medline is recalling five types of medical convenience kits because they contain the SafeAir Smoke Evacuation Pencil, which Stryker subsequently recalled.
Product
MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3) MAJOR VASCULAR PACK-LF, REF DYNJ0488546K; 4) PEDS CENTRAL LINE PACK, REF DYNJ84762; 5) PACK,CENTRAL LINE, REF DYNJ906907C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0241-2025·2024-12-11
Thirster Low Cal Fruit Recalled for Metal Fragment Contamination
Dyma Brands recalls Thirster Low Cal Fruit due to metal fragments in the product from a damaged sifter during dextrose production. The affected pouches were distributed across 29 states.
Product
THIRSTER LOW CAL FRUIT, NET WT. 8.6OZ, Case UPC 50758108397380, DISTRIBUTED BY US FOODS, INC. ROSEMONT, IL 60018
Category
Food
Distribution
30 states
HighFDA (Food)·F-0233-2025·2024-12-11
Sysco Pink Lemonade Drink Mix Recalled for Metal Fragment Contamination
Sysco Classic Pink Lemonade Drink Mix is recalled because a damaged sifter during production introduced metal fragments into the product. Products were distributed across 29 states.
Product
Sysco Classic Pink Lemonade Drink Mix Natural Flavor, NET WT. 24OZ(1 LB 8 OZ) 680 g, UPC 0 74865 09326 2, Case UPC 10074865093269, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
Category
Food
Distribution
30 states
HighFDA (Food)·F-0242-2025·2024-12-11
Chocolate Pudding Mix Recalled for Metal Fragment Contamination
Monarch Instant Chocolate Pudding & Pie Filling Mix is being recalled due to metal fragments introduced during production. The affected product was distributed to 29 states.
Product
MONARCH INSTANT CHOCOLATE PUDDING & PIE FILLING MIX NATURALLY AND ARTIFICIALLY FLAVORED, NET WT. 24OZ, Case UPC 50758108068983 DISTRIBUTED BY US FOODSS, INC ROSEMONT, IL 60018
Category
Food
Distribution
30 states
HighFDA (Devices)·Z-0596-2025·2024-12-11
Medical Device Breach: BACTEC 9240 System Faces Unauthorized Access Risk
Becton Dickinson recalled the BACTEC 9240 System after unauthorized actors accessed product service credentials. Until credentials are updated, there is risk of unauthorized access that may compromise system security and data integrity.
Product
BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0090-2025·2024-12-11
ROYALAB Germ Away Antibacterial Hand Soap Recalled for Failed Microbiological Testing
Midlab Incorporated is recalling ROYALAB Germ Away Antibacterial Hand Soap (1-gallon, Lot 0711241) due to out-of-specification microbiological test results. The product failed manufacturing quality standards.
Product
ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0585-2025·2024-12-11
BD EpiCenter Data Management System Credential Compromise Poses Unauthorized Access Risk
Service credentials for the BD EpiCenter Data Management System were accessed by an unauthorized actor. Until credentials are updated, system data and access controls are at risk.
Product
BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0231-2025·2024-12-11
Sysco Fruit Punch Drink Mix recalled for metal fragments
Sysco Classic Fruit Punch Drink Mix is being recalled due to metal fragments introduced by a damaged sifter during manufacturing. The affected product (Case UPC 00734730132709, Lot 263 EFA) was distributed across 29 states.
Product
Sysco Classic Fruit Punch Drink Mix Natural and Artificial Flavor, NET WT. 8.6OZ (244 G), Case UPC 00734730132709, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
Category
Food
Distribution
30 states
HighFDA (Devices)·Z-0586-2025·2024-12-11
Medical Device Data Management Software Affected by Unauthorized Service Credential Access
Service credentials for BD EpiCenter Data Management System were accessed by an unauthorized actor. This creates a risk of unauthorized access to the software and associated data until credentials are updated.
Product
BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0096-2025·2024-12-11
Prescription Drug Diltiazem Hydrochloride Recalled for Manufacturing Impurity
Glenmark Pharmaceuticals is recalling 5,232 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to an impurity that exceeds FDA safety limits. Patients currently taking this medication should contact their pharmacist or doctor.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0619-2025·2024-12-11
Medline MaxOrb Extra Alginate Wound Dressing Recalled for Packaging Defect
Advanced Medical Solutions is recalling 1,800 boxes of Medline MaxOrb Extra Alginate Wound Dressing due to defects in the primary packaging pouch that compromise sterile barrier integrity. Products affected were distributed in Illinois, Texas, and Virginia.
Product
MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0605-2025·2024-12-11
GE Healthcare Revolution Ascend CT System Recalled for Image Rotation
GE Healthcare Revolution Ascend CT systems can produce progressively rotated images during helical, cine, and cardiac scans. Images after the first may be rotated up to 56 degrees, potentially affecting diagnostic accuracy.
Product
GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0247-2025·2024-12-11
Ready-meal chicken tacos recalled due to Listeria monocytogenes
Albertsons ready-meal chicken street taco kits have been recalled due to potential Listeria monocytogenes contamination in the cooked chicken. The recall affects 2,374 units distributed across 21 U.S. states.
Product
(1) READY MEALS CHICKEN STREET TACOS SS COLD (UPC 27131600000) (2) READY MEALS ASADA STREET TACO MEAL SS COLD (UPC 29939100000) (3) READY MEALS CHICKEN STREET TACO MEAL SM SS COLD (UPC 27179600000)
Category
Food
Distribution
21 states
HighFDA (Devices)·Z-0577-2025·2024-12-11
Fluoroscopic X-ray System Hand Switch May Fail and Cause Unintended Radiation
The Ziehm Vision R fluoroscopic x-ray system has a hand switch that may fail under mechanical stress and cause unintended radiation. Ziehm Imaging, Inc. is recalling 5 affected units distributed in the U.S.
Product
Ziehm Vision R. Iterventional fluoroscopic x-ray system
Category
Medical Device
Distribution
1 state