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

10876–10900 of 31361

HighFDA (Devices)·Z-0107-2025·2024-10-23
[pending] Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system ut
Pending LLM rewrite. Source: FDA_DEVICE Z-0107-2025.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which incl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0059-2025·2024-10-23
Monarch Inflation Device Recalled Due to Sterile Barrier Breaches
Merit Medical Systems is recalling 1,120 Monarch Inflation Devices due to manufacturing defects causing holes and breaches in the sterile Tyvek barrier. Affected devices distributed worldwide may pose contamination risk during cardiac interventions.
Product
Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measur
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0101-2025·2024-10-23
AVVIGO+ Medical Imaging System Grid Overlay Display Software Error
Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software anomaly that displays a 9-grid overlay instead of the correct 15-grid overlay during Live and Record modes. This incorrect display could affect imaging measurements during procedures.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalitie
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0061-2025·2024-10-23
Monarch Inflation Device Syringe Recalled for Sterile Barrier Defect
Merit Medical Systems is recalling 51,900 Monarch Inflation Device syringes due to manufacturing defects causing breaches in the sterile barrier. The devices are used in balloon angioplasty procedures. No injuries have been reported.
Product
Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty cathete
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0129-2025·2024-10-23
Rolling Walker Backrest May Disengage During Position Adjustment
Nova Ortho-Med is recalling 1,886 MONARCH ROLLATOR BLUE rolling walkers due to a potential fall hazard. The backrest may disengage when users shift from a slouched to upright seated position.
Product
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0089-2025·2024-10-23
Cryostat Model CM1950 Lacks Warning on Flammable Spray Use
Leica Biosystems is recalling the Cryostat Model CM1950 due to missing warnings about using flammable freezing sprays in the device. Flammable sprays can ignite inside the chamber, potentially causing serious injuries.
Product
Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and sectioning tissue samples
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0096-2025·2024-10-23
Boston Scientific Medical Device Software Error Affects Vessel Imaging Display
The Boston Scientific AVVIGO+ Guidance System displays an incorrect grid overlay when used with the OptiCross 18 catheter in Live or Record mode, potentially affecting depth reference settings. No injuries have been reported.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0062-2025·2024-10-23
Monarch Balloon Angioplasty Syringes Recalled Due to Sterile Barrier Defects
Merit Medical Systems is recalling 432 Monarch 30 ATM syringes used in balloon angioplasty procedures due to manufacturing defects creating holes in the sterile Tyvek barrier.
Product
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0050-2025·2024-10-23
Stir Fried Dried Shrimp Recalled for Undeclared Wheat Allergen
Lemonland Food Corp recalled stir-fried dried shrimp (Item FLD1971) distributed in Washington because wheat is not declared on the label, despite being present in the product.
Product
Item FLD1971, Stir Fried Dried Shrimp, distributed in plastic clamshell containers. Net wt. 0.165lb. The H-Mart label declares: Shrimp, Sesame Oil, Soy Sauce, Corn Syrup, Salt
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0071-2025·2024-10-23
Merit Medical basixSKY Inflation Device Recalled for Sterile Barrier Defect
Merit Medical is recalling the basixSKY Inflation Device because a sterile barrier defect could expose users to harmful pathogens and bacteria, risking infection.
Product
basixSKY Inflation Device, REF: SKY1802
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0091-2025·2024-10-23
Cue Health COVID-19 Test Cartridge Recalled for Unapproved Distribution
Cue Health Inc. is recalling 248,109 COVID-19 test kits (56 lots) that were modified and distributed without FDA approval or authorization. Users should discontinue use and contact the manufacturer.
Product
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0013-2025·2024-10-23
First Aid Antiseptic Ointment Recalled for Mislabeled Inactive Ingredients
Rugby Laboratories is recalling First Aid Antiseptic (Povidone-Iodine 10%) ointment because the product contains undeclared inactive ingredients not listed on the label.
Product
FIRST AID ANTISEPTIC — FIRST AID ANTISEPTIC (POVIDONE-IODINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0031-2025·2024-10-23
King Harvest Spinach Hummus Recalled for Potential Plastic Fragments
Pacific Coast Fresh CO is recalling 994 tubs of King Harvest Spinach Hummus due to potential plastic fragments. The hummus was distributed in Oregon and Washington with a use-by date of 10/08/24.
Product
King Harvest Spinach Hummus, perishable and refrigerated, packed in plastic tubs with tamper evident lids. Net wt. 10oz. Dist. Exclusively by Pacific Coast Fresh Co Portland, Oregon. UPC 0 25726 31108 7.
Category
Food
Distribution
2 states
HighFDA (Food)·F-0045-2025·2024-10-23
Stewed Lotus Root Recalled for Undeclared Wheat and Fish Allergens
Lemonland Food Corp is recalling Stewed Lotus Root for undeclared wheat and fish allergens. The product label does not declare wheat or fish (anchovy), which are present in the product.
Product
Item FLD1015A, Stewed Lotus Root, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares: Lotus Root, Salt, Soy Sauce, Corn Syrup
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0085-2025·2024-10-23
Leica Cryostat Model CM1100 Recalled for Fire Risk from Flammable Freezing Sprays
Leica Biosystems recalls its Cryostat Model CM1100 due to inadequate warnings about using flammable freezing sprays, which can ignite and cause serious injuries. The device labeling lacked required safety warnings prior to 2019.
Product
Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0029-2025·2024-10-23
Premium Grapenut Frozen Dessert Recalled for Undeclared Food Coloring
Today's Frozen Desserts is recalling Premium Grapenut frozen dessert products sold in Florida due to undeclared Yellow 5 and Yellow 6 food coloring additives not listed on product labels.
Product
Premium Grapenut, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen
Category
Food
Distribution
0 states
ModerateFDA (Food)·F-0051-2025·2024-10-23
El Gallo Azul Processed Cheese Recalled for Non-English Labeling
El Gallo Azul Cock Brand Queso Procesado processed cheese in 300g metal cans is recalled for non-English labeling. The product was distributed in Oregon.
Product
El Gallo Azul Cock Brand Queso Procesado/Processed Cheese 300g packaged in a metal can
Category
Food
Distribution
0 states
ModerateFDA (Devices)·Z-0102-2025·2024-10-23
Boston Scientific AVVIGO+ guidance system recalled for grid overlay display error
Boston Scientific's AVVIGO+ guidance system is recalled because a software glitch causes an incorrect grid overlay display when used with an OptiCross 18 catheter. The correct overlay appears in Review mode, and no patient injuries have been reported.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0032-2025·2024-10-23
Great Value Mixed Fruits Variety Pack Recalled for Undeclared Food Dye
Walmart is recalling Great Value Diced Peaches, Mandarin Segments, & Cherry Mixed Fruits Variety Pack because FD&C Red No. 3 was not declared on the label. The recall affects 511,164 units distributed nationwide.
Product
Great Value Diced Peaches, Mandarin Segments, & Cherry Mixed Fruits Variety Pack, 4 oz, 12 Pack
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0112-2025·2024-10-23
Medical imaging system software defect causes incorrect grid overlay display
Boston Scientific recalled the AVVIGO+ imaging guidance system due to a software defect that displays a 9-grid overlay instead of the correct 15-grid overlay when connected to OptiCross 18 catheters in Live or Record mode.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0011-2025·2024-10-23
Prescription Dapsone Gel 7.5% Recalled Due to Crystallization
Viona Pharmaceuticals has voluntarily recalled 2,544 pumps of Dapsone Gel 7.5% (Lot #T400512) due to crystallization. The affected product was distributed in New York.
Product
DAPSONE — DAPSONE (DAPSONE)
Category
Drug
Distribution
1 state
ModerateFDA (Food)·F-0026-2025·2024-10-23
Rum Raisin Ice Cream Recalled for Undeclared Yellow 5 and Yellow 6
Today's Frozen Desserts has recalled Rum Raisin ice cream distributed in Florida due to undeclared Yellow 5 and Yellow 6 food colorants. Approximately 1,363 units are affected.
Product
Rum Raisin Ice Cream, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen
Category
Food
Distribution
0 states
ModerateFDA (Food)·F-0033-2025·2024-10-23
Great Value Cherry Mixed Fruit Recalled for Undeclared Food Colorant
Walmart is recalling Great Value Cherry Mixed Fruit cups nationwide because FD&C Red No 3 was not declared as an ingredient on the label.
Product
Great Value Cherry Mixed Fruit, 4 oz, 4 Count and 12 count plastic cups sealed with clear film.
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0027-2025·2024-10-23
Rum Nut Ice Cream Recalled Due to Undeclared Yellow 5 and Yellow 6
Today's Frozen Desserts recalls Rum Nut Ice Cream distributed in Florida due to undeclared Yellow 5 and Yellow 6 food colorants. The recall affects 1,363 units with expiration dates from June 13 to September 13, 2025.
Product
Rum Nut Ice Cream, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen
Category
Food
Distribution
0 states
ModerateFDA (Devices)·Z-0123-2025·2024-10-23
Medical Device Kit Incorrectly Labeled With Wrong Model Number
Medline Industries recalls MEDLINE KIT CV I II vessel cannulae kits because product for model 30001 was incorrectly labeled as model 30000 during manufacturing.
Product
MEDLINE KIT CV I II, REF DYNJ906071B
Category
Medical Device
Distribution
Distributed nationwide

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10876–10900 of 31361