Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

16301–16325 of 31567

HighFDA (Food)·F-0505-2024·2023-12-20
TYSON 2.0 Kava & Kratom Supplement Recalled for Unapproved Additive and pH Control Failure
LGNDS LLC is recalling TYSON 2.0 Kava & Kratom Blend supplement because the product contains kratom, an unapproved food additive, and has a pH above safe levels for an acidified product.
Product
TYSON 2.0, TYSON TONIC KAVA & KRATOM BLEND, FRUIT PUNCH, 2oz (60ml), Supplement Facts, Kava Root Extract (30%) 1200mg, Kratom Leaf Extract (30%) 120mg, (Providing 36mg Mitragynine), www.tyson20global.com, LGNDS, LLC, UPC: 850043583622, POWERED BY LGNDS, 12 bottles of 2oz each per
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0528-2024·2023-12-20
Sterile PVP Medical Solution Recalled for Non-Sterile Contents
Medline Industries is recalling 700 units of Sterile PVP solution because the labeling claims sterility but the contents are non-sterile. The affected products were distributed nationwide in eight states.
Product
STERILE PVP, REF DYNDA1649
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0535-2024·2023-12-20
Medical Device Recall: Medline Leg Bag with Undeclared Latex
Medline is recalling 144 Leg bag devices (model REF URO12573) distributed in the US and Panama due to undeclared latex that may cause allergic reactions in sensitive users.
Product
Medline Leg bag, REF URO12573
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0520-2024·2023-12-20
Medical Device Recall: Para-Pak Zn-PVA Stool Collection Vials for Leakage Risk
Meridian Bioscience is recalling Para-Pak Zn-PVA stool specimen collection vials due to a manufacturing defect that may cause leakage and risk exposure to biological hazards.
Product
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0573-2024·2023-12-20
Frozen and Refrigerated Cheese Products Recalled Due to Temperature Abuse
Ben E Keith Foods - Fort Worth is recalling frozen and refrigerated cheese products that were subjected to temperature abuse during storage and transport.
Product
CHEESE VELVEETA LOAF; CHEESE CHEDDAR SLICE MILD; CHEESE STICK MOZZ BATTERED; CHEESE CHEDDAR SLICE MILD
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0547-2024·2023-12-20
Laboratory Diagnostic System Software Malfunction Causes System Freezes and Delays
Ortho-Clinical Diagnostics recalls 216 VITROS XT 7600 laboratory systems running Software Version 3.8.0 due to software issues causing screen freezes and unresponsiveness. The defects delay test result reporting and could postpone patient treatment.
Product
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0521-2024·2023-12-20
Cardinal Health Stool Transportation System Recalled for Vial Leakage
Meridian Bioscience is recalling the Cardinal Health Clean Stool Transportation System due to a manufacturing defect that may cause Para-Pak vials to leak. Affected product: 38 cases with Lot Number 510020Q, distributed nationwide and to Italy.
Product
Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0658-2024·2023-12-20
Gaw's Italian Sub Recalled for Undeclared Sesame Allergen
Gaws Gourmet Foods is recalling Gaw's Classic Italian sub due to undeclared sesame. The recall affects 699 units distributed in Michigan; consumers who are allergic to sesame should not consume the product.
Product
Gaw's Classic Italian sub 8oz, Foam Tray with Clear Plastic Wrap package, UPC:1725600920
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0530-2024·2023-12-20
Non-sterile Betadine solution labeled and distributed as sterile
Medline Industries is recalling 1,800 units of Sterile Betadine (Ref DYNDA1998) because the foil sachet contents are non-sterile, despite labeling that claims sterility. The recall affects units nationwide in eight states.
Product
STERILE BETADINE, REF DYNDA1998
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0546-2024·2023-12-20
Chemistry System Software Malfunction Causes Freezes and Result Reporting Delays
Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to software issues causing screen freezes and system unresponsiveness. The problems can delay reporting of patient test results, including critical or STAT assays.
Product
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0555-2024·2023-12-20
CARDIOHELP-i Heart-Lung Support System: Incorrectly Documented Factory Settings
The CARDIOHELP-i Heart-Lung Support System is recalled because factory settings were incorrectly described in the manual. Healthcare providers should verify device settings with the manufacturer.
Product
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass Part Number: 701072780, (CARDIO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0580-2024·2023-12-20
Sienna Bakery Chocolate Decadent Brownies Recalled for Undeclared Peanuts
Sienna Bakery Chocolate Decadent Brownies are being recalled due to undeclared peanuts. Consumers with peanut allergies should not consume this product.
Product
Sienna Bakery Chocolate Decadent Brownies (Tray)
Category
Food
Distribution
14 states
HighFDA (Devices)·Z-0527-2024·2023-12-20
Sterile Prep Stick Recall: Non-Sterile Contents Despite Sterile Labeling
Medline Industries is recalling sterile prep sticks (REF DYNDA1134) labeled as sterile that contain non-sterile solution, posing infection risk in medical procedures.
Product
STERILE STERILE PREP STICK, REF DYNDA1134
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0524-2024·2023-12-20
Medical Device Recall: PHYSICA HPS Tibial Liner Incorrect Labeling
Limacorporate is recalling 33 PHYSICA HPS Tibial Liner units distributed in the U.S. due to incorrect product labeling. No adverse events have been reported.
Product
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0545-2024·2023-12-20
Laboratory Diagnostic System Software Defects Cause System Freezes and Result Delays
The VITROS 5600 laboratory analyzer is being recalled due to software issues causing screen freezes and printer disconnections that delay test result reporting, potentially affecting patient care.
Product
VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0553-2024·2023-12-20
X-ray system overhead suspension components may fall due to incorrect bolt torque
GE HealthCare Definium Tempo and Tempo Pro X-ray systems may have been assembled with incorrect bolt torque, creating a risk that Overhead Tube Suspension components could fall.
Product
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD sy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0516-2024·2023-12-20
FDA Recalls 4Kscore Prostate Cancer Diagnostic Test Over Model Concerns
BioReference Health is recalling the 4Kscore Test, a prostate cancer risk diagnostic test used nationwide. The recall follows mathematical modeling performed on over 3,000 specimens regarding digital rectal exam (DRE) information requirements.
Product
The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following i
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0533-2024·2023-12-20
FDA Recalls Medline Leg Bags for Undeclared Latex
Medline leg bags contain undeclared latex, creating a risk for users with latex allergies. The company is recalling 28,942 devices distributed in the US and Panama.
Product
Medline Leg bag, REF DYND12574
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0554-2024·2023-12-20
Sensica Urine Output System displays incorrect timestamps when connected to WiFi
The Sensica Urine Output System (SCCS1002) displays incorrect timestamps and monitoring data when connected to WiFi or internet due to a time synchronization issue. This malfunction affects the accuracy of patient monitoring records.
Product
Sensica Urine Output System, Catalog Number SCCS1002
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0544-2024·2023-12-20
FDA Recalls VITROS 4600 Chemistry System for Software-Related Freezes
Ortho-Clinical Diagnostics is recalling 51 units of the VITROS 4600 Chemistry System due to software defects causing system freezes and disconnections that could delay critical test result reporting.
Product
VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0657-2024·2023-12-20
Food recall: Gaw's Deluxe Italian sub due to undeclared sesame allergen
Gaws Gourmet Foods is recalling Gaw's Deluxe Italian sub sandwiches because sesame was not declared on the label. The recalled products were distributed in Michigan.
Product
Gaw's Deluxe Italian sub 12oz, Foam Tray with Clear Plastic Wrap package, UPC:1725600910
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0523-2024·2023-12-20
Collision Sensor Malfunction in Siemens ARTIS Icono Fluoroscopic X-Ray System
The ARTIS icono fluoroscopic x-ray system may falsely detect collisions for up to 30 minutes after startup, requiring manual override with reduced safety protection and limiting diagnostic use.
Product
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0510-2024·2023-12-20
Wilcox Premium Coffee Recalled Due to Listeria Contamination
Wilcox Premium Coffee products with Best By dates from September 14 to November 14, 2024, may be contaminated with Listeria monocytogenes. Products were distributed in Vermont, New Hampshire, Massachusetts, and New York.
Product
Wilcox Premium Coffee; 4 oz Cup; UPC 04372600403; Wilcox Premium Coffee in 1.5QT, Quart, Pint, 3 Gallon, and 1 Gallon sizes
Category
Food
Distribution
4 states
HighFDA (Food)·F-0567-2024·2023-12-20
Sheetz snack mix recalled for undeclared soy allergen
Sheetz M.T.go! Double Dipped Chocolatey Peanut Butter Peanuts Snax Mix is being recalled because it contains undeclared soy. The product was distributed in North Carolina, Virginia, and West Virginia.
Product
Top Label Reads: SHEETZ M.T.go! Made"To"Go DOUBLE DIPPED CHOCOLATEY PEANUT BUTTER PEANUTS SNAX MIX NET WT 6.55 OZ (186 G) Back Panel Reads: SWEET & SPICY SNAX MIX DISTRIBUTED BY SHEETZ DISTRIBUTION SERVICES, LLC. CLAYSBURG, PA 16625 UPC 7 59465 00629 3
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-0519-2024·2023-12-20
Para-Pak Clean Vial Stool Collection Kits Recalled for Manufacturing Defect
Meridian Bioscience is recalling Para-Pak Clean Vials used for stool specimen collection due to a manufacturing defect that increases leakage risk and may expose users to biological hazards.
Product
Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
Category
Medical Device
Distribution
Distributed nationwide

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16301–16325 of 31567