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

3626–3650 of 13449

HighFDA (Devices)·Z-1317-2025·2025-03-19
ZOLL Powerheart G5 AED May Fail Self-Test After Environmental Exposure
ZOLL Powerheart G5 AED devices may fail their self-test if exposed to extreme temperatures or humidity. Approximately 56,981 units are being recalled nationwide and internationally.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1303-2025·2025-03-19
GE Healthcare CT Scanner Systems Recalled Due to Coolant Leak Risk
GE Healthcare is recalling 21 Revolution CT and Revolution Apex series CT systems due to potential coolant fluid leaks near the gantry base. The leaking fluid poses a slip-and-fall hazard if not cleaned up promptly.
Product
GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1323-2025·2025-03-19
ZOLL Powerheart G5 AED Devices Recalled for Self-Test Failure Risk
ZOLL is recalling 8,744 Powerheart G5 AED units that may fail their self-test if exposed to extreme temperatures or humidity, potentially masking device malfunctions.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrilla
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1314-2025·2025-03-19
COR Disposable Cartilage Transplant Kit recalled for missing graft loader pin
DePuy Mitek's COR Disposable Cartilage Transplant System is being recalled because some units are missing a pin in the graft loader component, which could affect surgical function.
Product
COR Disposable Kit, 8 mm. Cartilage Transplant System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1302-2025·2025-03-19
GE Revolution CT Systems Potential Coolant Leak Slip-and-Fall Risk
GE Healthcare Revolution CT systems may leak glycol coolant near the gantry base. While the non-toxic fluid poses no chemical hazard, it creates a slip-and-fall risk if not noticed and cleaned.
Product
GE Healthcare Revolution CT, System, X-ray, Tomography, Computed
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1301-2025·2025-03-19
GE Healthcare Revolution CT systems recalled for potential coolant leaks
GE Healthcare is recalling Revolution CT and Revolution Apex series systems due to potential coolant fluid leaks from the gantry base, which could create a slip and fall hazard.
Product
GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1244-2025·2025-03-12
Rotarex Atherectomy Catheter Recalled for Helix Fracture Risk
Bard is recalling Rotarex Atherectomy System catheters due to potential helix fracture or breakage that could cause vessel injury and severe bleeding. Updated instructions are being distributed to clarify procedural steps to reduce this risk.
Product
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1257-2025·2025-03-12
Insulin pump recall: Medtronic Paradigm models malfunction during airplane flight
Medtronic MiniMed's Paradigm insulin pumps can malfunction during airplane flight due to air pressure changes, potentially causing dangerously high or low blood sugar levels that could be fatal.
Product
Paradigm insulin pump, REF: MMT-754
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1254-2025·2025-03-12
Baxter Spectrum IQ Infusion System may have missing motor mounting screws
Baxter Spectrum IQ Infusion Systems may lack motor mounting screws due to a servicing defect. The FDA Class I recall affects 323 units distributed nationwide.
Product
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1263-2025·2025-03-12
Insulin Pump Recalled for Abnormal Delivery During Flight Pressure Changes
Medtronic MiniMed 720G insulin pumps may malfunction during airplane travel due to air pressure changes, causing abnormal insulin doses that can lead to severe low or high blood sugar emergencies.
Product
MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1246-2025·2025-03-12
Medtronic Pipeline Vantage device recall: deformation may cause blood clots
The Pipeline Vantage Embolization Device may malfunction, with the braid deforming or not positioning correctly, potentially causing blood clots. Approximately 7,820 units are affected worldwide.
Product
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1205-2025·2025-03-12
FDA Recalls VARIPULSE Bi-Directional Ablation Catheter Due to Neurovascular Events
Biosense Webster is recalling VARIPULSE Bi-Directional Ablation Catheters (REF D141201) due to an observed trend of neurovascular events. The FDA issued a Class I recall affecting approximately 497 units distributed worldwide.
Product
VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomat
Category
Medical Device
Distribution
10 states
SevereFDA (Devices)·Z-1253-2025·2025-03-12
Baxter Sigma Spectrum Infusion System Recalled for Missing Mounting Screws
Baxter Healthcare is recalling 66 units of Sigma Spectrum Infusion System (V6) due to potential missing motor mounting screws that may have occurred during servicing. Missing screws could affect the device's operation.
Product
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1245-2025·2025-03-12
Medtronic Pipeline Vantage Embolization Device Recall for Structural Deformation Risk
Medtronic is recalling approximately 18,245 unused Pipeline Vantage embolization devices due to incomplete wall apposition and braid deformation that may lead to thrombosis and serious adverse events.
Product
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1294-2025·2025-03-12
Tissue Approximation System zip-ties at risk of breaking during implantation
TAS Medical is recalling Tissue Approximation System models because tissue approximation straps (zip-ties) may break before or during surgery. Undetected breaks could lead to hernia recurrence requiring additional corrective surgery.
Product
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1262-2025·2025-03-12
Medtronic MiniMed insulin pump recalled for abnormal delivery during air pressure changes
Medtronic MiniMed insulin pumps may deliver insulin abnormally during airplane take-off or landing due to air pressure changes, risking severe low or high blood sugar emergencies.
Product
MiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1255-2025·2025-03-12
Medtronic Paradigm insulin pumps may deliver incorrect doses during flight
Medtronic MiniMed insulin pumps may deliver abnormally high or low insulin doses in response to air pressure changes during airplane takeoff and landing, potentially causing severe hypoglycemia or hyperglycemia.
Product
Paradigm REF: MMT-712 and MMT-715
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1266-2025·2025-03-12
Medtronic MiniMed insulin pumps may deliver abnormal insulin doses during flight
Medtronic MiniMed insulin pumps may deliver abnormal doses of insulin during airplane takeoff or landing due to air pressure changes. This can result in severe hypoglycemia or hyperglycemia, with potential for seizure, coma, or death.
Product
MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1276-2025·2025-03-12
Osstem dental implant abutments mislabeled on patient chart stickers
Hiossen is recalling 119 Osstem dental implant abutments because patient chart stickers incorrectly identify product versions. ET Rigid and ET Multi abutments are labeled backwards, potentially leading to selection of the wrong abutment size.
Product
Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA505RV1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1265-2025·2025-03-12
MiniMed Insulin Pump May Malfunction at High Altitude During Flight
Medtronic MiniMed insulin pumps may deliver abnormal insulin doses during airplane takeoff or landing due to air pressure changes, potentially causing severe low or high blood sugar.
Product
MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1258-2025·2025-03-12
MiniMed Insulin Pumps Recalled for Abnormal Delivery During Air Travel
Medtronic recalled MiniMed insulin pumps due to abnormal delivery caused by air pressure changes during airplane flights. The defect can cause severe hypoglycemia or hyperglycemia, potentially leading to seizure, coma, or death.
Product
MiniMed insulin pump, REF: 620G (MMT-1750)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1270-2025·2025-03-12
Philips BGM 4 Blood Glucose Meter Battery Expansion Risk Recall
Telcare recalls 34,764 Philips BGM 4 blood glucose meters (Model TM0009) nationwide due to battery expansion and swelling. The battery may cause the back cover to separate or, in worst-case scenarios, explode. No injuries reported to date.
Product
Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1249-2025·2025-03-12
Access Erythropoietin Reagent Lot Produces Falsely Decreased Test Results
Beckman Coulter's Access Erythropoietin (EPO) reagent lot 439363 produces falsely decreased test results with patient samples. Affected results may lead to improper diagnosis or unnecessary repeat testing.
Product
Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis) in mammals. Renal production of EPO is regulated by changes in oxygen availabil
Category
Medical Device
Distribution
24 states
HighFDA (Devices)·Z-1261-2025·2025-03-12
Medtronic MiniMed insulin pump recalled for air pressure-triggered delivery defect
Medtronic MiniMed insulin pumps can deliver abnormal insulin doses during air pressure changes in airplane travel, risking severe hypoglycemia or hyperglycemia and serious complications.
Product
MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1259-2025·2025-03-12
MiniMed Insulin Pumps Recalled for Abnormal Insulin Delivery During Flight
MiniMed insulin pumps may deliver abnormal insulin doses during aircraft takeoff and landing due to air pressure changes, risking severe blood sugar fluctuations, seizures, and potentially fatal complications.
Product
MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
Category
Medical Device
Distribution
Distributed nationwide

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3626–3650 of 13449