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

8576–8600 of 113902

HighFDA (Devices)·Z-2028-2025·2025-07-02
REMISOL Advance Medical Device Software Defect Affecting Reference Range Calculations
A software issue in REMISOL Advance may incorrectly process date-of-birth information from laboratory systems, causing incorrect reference range calculations and potentially auto-validating erroneous test result flags. The actual test results are not changed, but their evaluation may be affected.
Product
REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 con
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2029-2025·2025-07-02
GE Healthcare LOGIQ F R3 Ultrasound System Incorrect Fetal Weight Data Display
GE Healthcare is recalling the LOGIQ F R3 ultrasound system because it may display previous obstetric patient data in fetal weight measurements, potentially leading to incorrect clinical decisions about fetal size and growth.
Product
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2001-2025·2025-07-02
BD Insyte Autoguard Winged IV Catheter needle retraction failure recall
Becton Dickinson is recalling BD Insyte Autoguard Winged IV Catheters (Ref. 381533, Lot 4282452) because the catheter needle may be slow to retract or fail to retract entirely.
Product
REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1996-2025·2025-07-02
DxI 9000 Access Immunoassay Analyzer calibration system error recall
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer C11137 due to calibration issues where curves switch from passed to failed status due to system errors, potentially causing erroneous test results.
Product
DxI 9000 Access Immunoassay Analyzer C11137
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0070-2025·2025-07-02
Big O' Smokehouse Whitefish Spread recalled for plastic contamination
Big O' Smokehouse is recalling 4lb and 8oz containers of Whitefish Spread due to white plastic fragments found in the product. The affected spread was distributed to retail stores and distributors in Michigan and Illinois.
Product
Big O' Smokehouse 4lb Whitefish Spread Big O' Smokehouse 8oz Whitefish Spread Packaged in plastic containers
Category
Food
Distribution
2 states
ModerateFDA (Food)·H-0094-2025·2025-07-02
Probese Caps dietary supplement recalled for undeclared food dyes
Probese Caps, a dietary supplement with Iron sold in 90-count bottles, is being recalled because it contains undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) in the gelatin capsules.
Product
Probese Caps, dietary supplement with Iron. 90-count bottles. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2012-2025·2025-07-02
Caphosol Artificial Saliva sachets recalled for out-of-specification stability
Recordati Rare Diseases is recalling Caphosol Artificial Saliva 32-dose sachets because stability test results for Solution B were out of specification during process validation.
Product
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0090-2025·2025-07-02
Nootri Toto food product recalled due to insanitary conditions
East Africa Boutique, LLC is recalling Nootri Toto (1 kg packages) distributed to seven retailers in Indiana, Kentucky, Missouri, and Ohio due to products being held under insanitary conditions.
Product
Nootri Toto, Net Weight 1 kg, packaged in a cardboard box, packed 12 boxes per case
Category
Food
Distribution
4 states
ModerateFDA (Devices)·Z-2033-2025·2025-07-02
Jewel Precision Sterilization Container System Recalled for FDA Non-Clearance
Jewel Precision Reusable Rigid Sterilization Container System, Model JP-24-8, was not cleared by the FDA. The letter to file supporting the size change was insufficient.
Product
Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
Category
Medical Device
Distribution
1 state
ModerateFDA (Food)·H-0089-2025·2025-07-02
Super Cereal Plus fortified corn soya blend recalled for insanitary conditions
East Africa Boutique, LLC. is recalling Super Cereal Plus fortified corn soya blend (1.5 kg bags) distributed to retailers in four states because the products were held under insanitary conditions.
Product
Super Cereal Plus fortified corn soya blend, Net Weight 1.5 kg, packaged in a plastic foil bag, packed 9 bags per case
Category
Food
Distribution
4 states
ModerateFDA (Drugs)·D-0489-2025·2025-07-02
Dobutamine Injection Recall Due to Discoloration and Cracked Vials
Pfizer is recalling one lot of Dobutamine Injection (250 mg/20 mL) nationwide due to discoloration and discolored solution caused by cracked vials. Healthcare facilities should quarantine and return affected units.
Product
DOBUTAMINE — DOBUTAMINE (DOBUTAMINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2011-2025·2025-07-02
Altivate Reverse Torx Peripheral Screw package labeling mismatch
Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because the package labeling lists a different size than the actual product included inside.
Product
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthr
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-2027-2025·2025-07-02
Atellica CH Diluent Contaminated with Sodium Hypochlorite
Siemens Healthcare Diagnostics is recalling Atellica CH Diluent (SMN 11099300, Lot 0000195412) due to contamination with sodium hypochlorite, which may affect laboratory test results.
Product
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2026-2025·2025-07-02
Jewel Precision Reusable Rigid Sterilization Container System Instructions Mismatch
Jewel Precision Reusable Rigid Sterilization Container System (Model JP-24-6) is being recalled because the Instructions for Use do not match the FDA-cleared indications for use or sterility shelf life.
Product
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2009-2025·2025-07-02
Altivate Reverse Torx Peripheral Screw labeling mismatch recall
Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because package labeling lists a different size than the actual product included inside.
Product
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthr
Category
Medical Device
Distribution
18 states
ModerateFDA (Drugs)·D-0483-2025·2025-07-02
Tirzepatide Injections Pre-filled Syringe Recalled for Sterility Assurance
Thrive Health Solutions is recalling Tirzepatide Injections 20mg/mL pre-filled syringes due to lack of assurance of sterility. Approximately 826 syringes distributed nationwide are affected.
Product
Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0072-2025·2025-07-02
Nature Mills Sesame Rice Mix recalled for undeclared milk allergen
NatureMills US Incorporated is recalling Nature Mills Sesame Rice Mix, 200g, due to undeclared milk. The product was distributed in the USA via the firm's website.
Product
Nature Mills Sesame Rice Mix, 200g
Category
Food
Distribution
0 states
ModerateFDA (Food)·H-0093-2025·2025-07-02
Protrim Plus Dietary Supplement Recall for Undeclared Food Dyes
Protrim Plus dietary supplement 90-capsule bottles contain undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) in the gelatin capsules. The product was distributed nationwide and may pose a risk to consumers with dye sensitivities or allergies.
Product
Protrim Plus, dietary supplement. 90 capsule/bottles. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1995-2025·2025-07-02
Medline Umbilical Tray sterile packaging defect recall
Medline is recalling umbilical trays due to a possible packaging defect in the outer Tyvec pouch that protects the sterile product. The defect may compromise sterility.
Product
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0060-2025·2025-07-02
Madeline's Patisserie Butter Croissant Buns recalled for undeclared wheat
Element 112, LLC is recalling Madeline's Patisserie 4.25 Inch Butter Croissant Buns because they contain undeclared wheat, a major food allergen.
Product
Madeline's Patisserie 4.25 Inch Butter Croissant Bun, Net Wt. 4 lbs. 6 oz (1,984.47 g), packaged in a food safe polypropylene bag and packed in a food service case; 24 per case
Category
Food
Distribution
2 states
ModerateFDA (Food)·H-0088-2025·2025-07-02
Carley's Soft Baked Iced Lemon Cookies recalled for misbranded color
Carley's Inc. is recalling Soft Baked Iced Lemon Cookies because the label incorrectly identifies an artificial yellow color instead of listing it as FD&C Yellow #5 as required.
Product
Carley s Soft Baked Iced Lemon Cookies, 5.34oz Plastic Tray, clear film overwrap w/ Label, 12 units per case
Category
Food
Distribution
15 states
ModerateFDA (Food)·H-0091-2025·2025-07-02
Prothin Dietary Supplement Recall for Undeclared Food Dyes
Preventics, Inc. is recalling Prothin dietary supplement packets because they contain undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) in the gelatin capsules, which may affect consumers with dye sensitivities or allergies.
Product
Prothin, dietary supplement. Seven Packets containing 2 tablets and 4 capsules. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0059-2025·2025-07-02
Madeline's Patisserie Raspberry Croissants Recalled for Undeclared Wheat
Element 112, LLC is recalling Madeline's Patisserie Raspberry Croissants because they contain undeclared wheat, a major allergen. The recall affects approximately 194 cases distributed to four distributors in Michigan and Ohio.
Product
1) Madeline's Patisserie 2.5 ounce Raspberry Croissant, Net Wt. 4 lbs. (1,814.37 g), packaged in a food safe polypropylene bag and packed in a food service case; 24 per case 2) Madeline's Patisserie 3.5 ounce Raspberry Croissant, Net Wt. 6 lbs. 10 oz. (3,005.05 g), packaged in a
Category
Food
Distribution
2 states
ModerateFDA (Food)·H-0092-2025·2025-07-02
Super ProTHIN Plus Dietary Supplement Recalled for Undeclared Dyes
Preventics, Inc. dba Legere Pharmaceuticals is recalling Super ProTHIN Plus dietary supplement because gelatin capsules contain undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) food colorings.
Product
Super ProTHIN Plus, dietary supplement. Seven Packets with 2 tablets & 4 Capsules and 1 packet with 14 Nutrilean capsules. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1998-2025·2025-07-02
LUCAS Chest Compression System demonstration units recalled
Jolife AB is recalling LUCAS 2, 3, and 3.1 chest compression system demonstration units that may have been provided to customers for clinical use instead of demonstration purposes only.
Product
LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.
Category
Medical Device
Distribution
Distributed nationwide

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8576–8600 of 113902