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

11001–11025 of 31361

HighFDA (Devices)·Z-0009-2025·2024-10-09
BD FACSDuet Sample Preparation System software defect causes inaccurate specimen volumes
The BD FACSDuet sample preparation system may dispense specimen volumes that are 3% to 20% higher in one tube versus another, leading to inaccurate blood counts, delayed test results, and potential additional blood collection. The defect affects 130 systems distributed across the US and internationally.
Product
BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-0006-2025·2024-10-09
Miami J Select Collar Recalled Due to Adhesive Failure
Ossur is recalling Miami J Select Collars due to pressure-sensitive adhesive hooks that may peel off during repeated use, potentially reducing cervical spine immobilization effectiveness.
Product
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-3309-2024·2024-10-09
Stryker Tornier Shoulder Implant Insert May Not Seat Securely
Tornier Inc. is recalling 38 Stryker Tornier Perform Humeral System Reversed Inserts (model REF DWP2393) due to inverted locking rings. The defect may prevent the insert from seating securely in the implant stem or spacer.
Product
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3304-2024·2024-10-09
ADVIA Centaur aTPO Assay kits recalled due to positive result bias
Siemens Healthcare is recalling 5,622 ADVIA Centaur aTPO Assay kits due to test accuracy issues. The affected lots produce results that are biased higher at and below the 60 U/mL threshold.
Product
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0018-2025·2024-10-09
Blueberry muffins recalled for undeclared milk and wheat allergens
The Posh Bakery, Inc. is recalling Whole Grains Blueberry Muffins (6 oz) due to undeclared milk (whey) and wheat flour, with missing allergen labeling and nutrition facts panel.
Product
Whole Grains Bakery labeled "Blueberry Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090 UPC"7 13583 05 102 3"
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-3313-2024·2024-10-09
Alcon contact lenses recalled for manufacturing quality defect
Alcon is recalling approximately 92,835 packs of contact lenses because a material quality issue may affect lens performance standards. Wearers may experience temporary eye irritation, redness, or blurred vision.
Product
DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
Category
Medical Device
Distribution
51 states
HighFDA (Food)·F-0013-2025·2024-10-09
Big Bottom Milk Chocolate Milk Recalled for Inadequate Pasteurization
Big Bottom Milk Company is recalling 701 units of Chocolate Milk Grade A (1-pint bottles) distributed in Georgia, North Carolina, and South Carolina due to failure to achieve required pasteurization temperatures.
Product
BIG BOTTOM MILK COMPANY, CHOCOLATE MILK GRADE A, 1 US Pint (0.473 liters), Big Bottom Milk Company 221 Hogan Rd, Forest City, NC, Expiration Date 09/09/2024 UPC code 850061506078
Category
Food
Distribution
3 states
HighFDA (Food)·F-0017-2025·2024-10-09
Chocolate chip muffins recalled for undeclared milk and wheat
The Posh Bakery is recalling Whole Grains chocolate chip muffins due to undeclared milk and wheat allergens with missing allergen labeling. Those with milk or wheat allergies should not consume this product.
Product
Whole Grains Bakery labeled "Choclate Chip Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090 UPC"7 13583 05 105 4"
Category
Food
Distribution
0 states
HighFDA (Food)·F-0021-2025·2024-10-09
Carrot Muffins Recalled for Undeclared Milk, Wheat, and Coconut Allergens
The Posh Bakery is recalling Carrot Muffins due to undeclared whey (milk), wheat flour, and coconut allergens, plus missing nutrition facts and allergen labeling. Consumers with allergies should not consume this product.
Product
Whole Grains Bakery labeled "Carrot Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090 UPC"7 13583 05 108 5"
Category
Food
Distribution
0 states
HighFDA (Drugs)·D-0001-2025·2024-10-09
Prescription atorvastatin bottles recalled for containing wrong medication
A carbamazepine (anticonvulsant) tablet was found in bottles of atorvastatin (cholesterol medication). The affected lot includes 2,328 bottles distributed nationwide.
Product
ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3305-2024·2024-10-09
Atellica IM aTPO Assay Diagnostic Test Recalled for Measurement Bias
Siemens Healthcare Diagnostics is recalling 9783 kits of the Atellica IM aTPO Assay diagnostic test due to positive bias in patient results below the 60 U/mL cut-off level, which may produce inaccurate test results.
Product
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0019-2025·2024-10-09
Hemodialysis console blood leak sensor may fail to trigger alarm
A component in certain Tablo Hemodialysis consoles may fail to detect small blood leaks promptly, potentially causing symptoms like hypotension, fatigue, and dizziness if undetected blood loss occurs.
Product
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Category
Medical Device
Distribution
46 states
HighNHTSA·24V668000·2024-10-09
Freightliner and Western Star brake lights may fail during emergency braking
Daimler Trucks is recalling certain Freightliner and Western Star trucks because brake lights may fail to illuminate during automatic emergency braking, increasing crash risk. Dealers will update software at no cost.
Product
FREIGHTLINER — 2025 FREIGHTLINER EM2
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0007-2025·2024-10-09
Pluvicto Radiopharmaceutical Drug Recalled Due to Manufacturing Quality Deviations
Advanced Accelerator Applications is recalling 99 doses of Pluvicto (lutetium LU-177 injection) due to manufacturing quality deviations. The affected lots were distributed to six states.
Product
Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61
Category
Drug
Distribution
6 states
HighNHTSA·23V650000·2024-10-09
2024 Hyundai Kona Seat Belt Retractor Malfunction Recall
Hyundai is recalling certain 2024 Kona vehicles because the rear seat belt retractors may not function properly. A defective seat belt could fail to restrain occupants in a crash, increasing injury risk.
Product
HYUNDAI — 2024 HYUNDAI KONA
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-0006-2025·2024-10-09
Sqwincher Electrolyte Beverage Mix recalled for potential metal contamination
Kent Precision Foods Group is recalling Sqwincher Electrolyte Beverage Mix (Orange powder, lot 2B0165712) due to potential metal contamination. The product was distributed in 11 states.
Product
Sqwincher Electrolyte Beverage Mix, Orange powder pack, Net Wt 47.66 oz (3lb) 1.35 kg: UPC 7588008834 / 16 per case / 5 gal yield item number 159016404
Category
Food
Distribution
11 states
HighFDA (Food)·F-0001-2025·2024-10-09
KARA BOONDHI Recalled for Undeclared Wheat Allergen
Grace Imports is recalling KARA BOONDHI due to undeclared wheat allergen on the label. The affected product was distributed to retail stores in Georgia.
Product
KARA BOONDHI INGREDIENTS: Gram flour, Edible beg oil (Refined Palmolein Oil), Chilly powder, Curry leaf, pepper, Asafoetida, Corn Flour, Urid dhall, Black salt. Natural Antioxidant (Mixed Tocopherol INS 305) ALLERGEN INFORMATION: Made in a FActory that Process Peanuts, Tree nuts,
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-3308-2024·2024-10-09
DVOT Rapid Antigen Test Kits Recalled for Lack of FDA Authorization
DVOT antigen test kits lack FDA authorization for US sale. Approximately 50,000 unauthorized kits were distributed. Users should discontinue use immediately due to unvalidated safety and accuracy.
Product
DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3312-2024·2024-10-09
Medical Display Unit Recalled for Unintended Touch Input During Patient Monitoring
Philips DIVA 24-inch touch display may generate unintended touch inputs, risking erroneous acknowledgement of patient alarms and delayed detection of patient condition changes. No injuries have been reported.
Product
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3306-2024·2024-10-09
DVOT SARS-CoV-2 Antigen Test Kit Recalled for Lack of FDA Authorization
The DVOT SARS-CoV-2 Antigen Test Kit (Model FCY-AGT-01) manufactured by Feng Chun Yuan Medical Equipment has been recalled from the U.S. market because it was not authorized for sale in the United States.
Product
DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-3307-2024·2024-10-09
DVOT SARS-CoV-2 and Influenza Antigen Test Kits lack FDA authorization
The DVOT SARS-CoV-2 & Influenza A+B Antigen Combo Test Kit (Model FAT01) has not obtained FDA authorization for sale in the United States. All lots distributed in the U.S. are subject to recall.
Product
DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-0006-2025·2024-10-09
Ryaltris Nasal Spray Recalled for Clogged Dip Tube
Ryaltris nasal spray is being recalled because the dip tube is clogged, preventing the spray from functioning. The recall affects 45,504 bottles distributed nationwide.
Product
RYALTRIS — RYALTRIS (OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0002-2025·2024-10-09
Ciclopirox Gel 0.77% Tubes Recalled Due to Broken Seals
Glenmark Pharmaceuticals is recalling Ciclopirox Gel 0.77% tubes nationwide due to broken seals. The recall affects 11,568 tubes; no illnesses or injuries have been reported.
Product
Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India, Manufactured f
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·23V591000·2024-10-08
Harley-Davidson Softail Motorcycles Recalled for Faulty Shock Absorber Fastener
Harley-Davidson is recalling certain 2018–2023 Softail motorcycles where a fastener securing the rear shock absorber may break, causing tire damage and loss of tire pressure. This can lead to loss of vehicle control and increased crash risk.
Product
HARLEY-DAVIDSON — 2021 HARLEY-DAVIDSON FXLRS
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·24V598000·2024-10-08
2020-2022 Ford Explorer Engine Compartment Fire Risk Recall
Certain 2020-2022 Ford Explorers may experience engine failures that release oil and fuel vapors, risking engine compartment fires. Ford will update the engine control software and inspect for bearing damage.
Product
FORD — 2020 FORD EXPLORER
Category
Vehicle
Distribution
Distributed nationwide

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11001–11025 of 31361