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

9051–9075 of 113902

HighFDA (Food)·F-0811-2025·2025-06-04
Mauna Loa Dark Chocolate Covered Macadamias Recalled for Undeclared Nuts
Hawaiian Host Candies is recalling Mauna Loa Dark Chocolate Covered Macadamias due to undeclared almond and cashew. The product label does not list these allergens and may pose a risk to consumers with tree nut allergies.
Product
Mauna Loa Dark Chocolate Covered Macadamias product is a snack product and packaged in 0.6oz and 4oz plastic flexible pouch. Dist. By Mauna Loa Macadamia Nut Corp. Kea au, Hawaii 96749, USA. Label declares Contains: Tree Nuts (Macadamia), Milk and Soy. Each master case contains
Category
Food
Distribution
17 states
HighFDA (Devices)·Z-1826-2025·2025-06-04
Cholestech LDX Lipid Profile and Glucose Test Kits Recalled
McKesson Medical-Surgical is recalling Cholestech LDX Lipid Profile+Glucose test kits due to transit delays and severe thunderstorms that may have exposed products to improper storage conditions, risking incorrect or delayed test results.
Product
ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1873-2025·2025-06-04
Umbilical Vessel Catheter 5 French Single Lumen Packaging Defect Recall
Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise sterility, risking infection in newborns if non-sterile products are used.
Product
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1863-2025·2025-06-04
GM Helix Acqua Implant dental implant size misidentification recall
Straumann USA LLC is recalling the GM Helix Acqua Implant (Article Number 140.985) because some packages labeled as 11.5 mm implants may contain 13 mm implants instead.
Product
GM Helix Acqua Implant, Article Number: 140.985
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1857-2025·2025-06-04
ELEOS Male-Female Midsection 40MM Orthopedic Component Recall
Onkos Surgical is recalling the ELEOS Male-Female Midsection 40MM component (Part Number 25001040E) of the ELEOS Limb Salvage System due to a potential assembly defect that could affect surgical positioning during implantation.
Product
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1816-2025·2025-06-04
Affinity 4 Birthing Bed Recalled for Faulty Actuator Signal Wires
Baxter Healthcare is recalling Affinity 4 Birthing Beds due to improper crimps on actuator signal wires that could prevent the bed or foot section from lowering. The defect affects 164 units distributed worldwide.
Product
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E100443, P3700E100444, P3700E100445, P3700E100446, P3700E100448, P3700E100449, P37
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1872-2025·2025-06-04
Cardinal Health Umbilical Vessel Catheter recalled for sterility defect
Cardinal Health is recalling Umbilical Vessel Catheters (Catalog No. 8888160333, 3.5 French single lumen) due to a packaging defect that may compromise sterility. Use of a non-sterile product could lead to infection in neonates.
Product
Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1875-2025·2025-06-04
Umbilical Vessel Catheter 5 French Triple Lumen Recall
Cardinal Health is recalling Umbilical Vessel Catheter 5 French triple lumen devices due to a packaging defect that may compromise sterility. Non-sterile catheters could lead to infection in neonates.
Product
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1864-2025·2025-06-04
NxStage PureFlow-B Solution Bags Perimeter Seal Failure Risk
NxStage Medical Inc is recalling NxStage PureFlow-B Solution bags nationwide due to potential perimeter seal failure on the small chamber, which could cause electrolyte fluid to splash into the user's face when opening the peel seam to mix chambers before treatment.
Product
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1879-2025·2025-06-04
Segmental Stem Components for ELEOS Limb Salvage System Recalled
Onkos Surgical is recalling segmental stem components of the ELEOS Limb Salvage System due to potential for breach of Tyvek seals. The affected components were distributed across multiple states.
Product
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-1823-2025·2025-06-04
Cardiohelp System HKH 8820 Wall Holder Mounting Bracket Recall
The Cardiohelp System HKH 8820 Wall Holder, a mounting bracket for the CARDIOHELP-i system used in interhospital transport, does not comply with standard DIN EN 1789:20 and may detach during use.
Product
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1877-2025·2025-06-04
BioFire Respiratory Panel 2.1 plus Kit recalled for manufacturing defect
BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1 plus Kit (Lot# 1475424) due to a manufacturing error that may cause elevated control failures and false negative test results.
Product
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Category
Medical Device
Distribution
0 states
HighNHTSA·25V324000·2025-06-04
2025 Nissan Frontier rear display may blank in reverse
The 2025 Nissan Frontier's center information display may show a blank screen in reverse, violating federal rear-visibility standards. This could reduce driver visibility and increase crash risk.
Product
NISSAN — NISSAN FRONTIER, KICKS
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1848-2025·2025-06-04
Abbott Diagnostics Vitamin D Calibrator Transit Storage Conditions Issue
The Abbott Diagnostics Architect Vitamin D 6-Level Calibrator was exposed to improper storage conditions during transit due to severe thunderstorms, which may result in incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1844-2025·2025-06-04
Abbott Diagnostics ARC T-Uptake Assay Reagent Recalled for Storage Excursion
Abbott Diagnostics ARC T-Uptake Assay reagent is being recalled because severe thunderstorms caused certain units to be stored outside recommended temperature conditions, which may result in incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1874-2025·2025-06-04
Umbilical Vessel Catheter 5 French Dual Lumen Packaging Defect Recall
Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise product sterility. Use of non-sterile catheters could lead to infection in neonates.
Product
Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1833-2025·2025-06-04
Ortho Clinical Diagnostics Vancomycin Reagent Cold Chain Recall
Mckesson Medical-Surgical is recalling Ortho Clinical Diagnostics Vancomycin reagent (Catalog No. 6801709) distributed nationwide due to transit delays and severe thunderstorms that may have caused storage outside recommended conditions, risking incorrect or delayed test results.
Product
ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1849-2025·2025-06-04
Abbott Diagnostics Architect Total T36X4ML Calibrator Cold Chain Excursion
Abbott Diagnostics Architect Total T36X4ML Calibrator units experienced transit delays during severe thunderstorms that may have caused storage outside recommended temperature conditions, potentially resulting in incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1871-2025·2025-06-04
Cardinal Health Umbilical Vessel Catheter Recall for Sterility Defect
Cardinal Health is recalling 1,710 units of Umbilical Vessel Catheter 2.5 French single lumen due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in neonates.
Product
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1881-2025·2025-06-04
Segmental Stem, Canal Filling, Straight 120MM recalled for seal breach
Onkos Surgical is recalling segmental stems used in the ELEOS LIMB SALVAGE SYSTEM due to potential breach of Tyvek seals. The breach could compromise the sterility of the medical device.
Product
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-1850-2025·2025-06-04
Abbott Diagnostics Architect Free T4 Calibrator Recall
Abbott Diagnostics Architect Free T4 Calibrator units may have been exposed to improper storage conditions due to transit delays from severe thunderstorms, potentially causing incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0813-2025·2025-06-04
Hummingbird Organic Roasted Salted Cashews recalled for undeclared hazelnut
Honey Heaven Wholesale Inc is recalling 6-oz bags of Hummingbird Organic Roasted Salted Cashews because the product contains hazelnut but the label does not declare it, creating a hazard for consumers with hazelnut allergies.
Product
Kraft package is labeled as Hummingbird Organic Roasted Salted Cashews, net wt. 6oz.
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-1870-2025·2025-06-04
Cardinal Health Umbilical Vessel Catheter Insertion Tray Recall
Cardinal Health is recalling one lot of umbilical vessel catheter insertion trays due to a packaging defect that may compromise sterility. Use of a non-sterile product on neonates could lead to infection.
Product
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1843-2025·2025-06-04
Abbott Diagnostics ARC Anti-TPO Assay Reagent Affected by Transit Delays
Abbott Diagnostics ARC Anti-TPO Assay 100TST B Reagent is being recalled because transit delays due to severe thunderstorms may have caused products to be stored outside recommended temperature conditions, increasing the risk of incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1830-2025·2025-06-04
Abbott HbA1c Hemoglobin Afinion Test Kit Cold Chain Failure
Abbott HbA1c Hemoglobin Afinion test kits are being recalled due to transit delays caused by severe thunderstorms that may have exposed products to storage temperatures outside the manufacturer's recommended range, potentially causing incorrect or delayed test results.
Product
ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
Category
Medical Device
Distribution
Distributed nationwide

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9051–9075 of 113902