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

3701–3725 of 13526

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
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-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
HighFDA (Devices)·Z-1250-2025·2025-03-12
TBS iNsight bone density software calculation variability on Hologic machines
TBS iNsight medical device software may produce inconsistent calculation results when operating on Hologic Horizon bone densitometers, particularly when comparing fast array scans to standard array scans.
Product
Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitom
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-1268-2025·2025-03-12
Heat Moisture Exchanger Connector Occlusion May Impair Ventilation
Kung Shin Plastics' CircuitGuard ThermoFlo Filter may have plastic obstructing the machine-side connector, preventing proper ventilation bag operation and risking oxygen deprivation during manual ventilation.
Product
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
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-1264-2025·2025-03-12
MiniMed Insulin Pump Models Recalled for Abnormal Delivery During Flight
Medtronic is recalling MiniMed insulin pumps due to air pressure changes during airplane takeoff and landing that can cause abnormal insulin delivery. Overdoses risk severe hypoglycemia; underdoses risk severe hyperglycemia and diabetic ketoacidosis.
Product
MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
Category
Medical Device
Distribution
Distributed nationwide
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-1256-2025·2025-03-12
Medtronic Paradigm insulin pump recall for abnormal delivery during flight
Medtronic MiniMed Paradigm insulin pumps may deliver incorrect insulin doses during airplane takeoff or landing due to air pressure changes. This can cause severe high or low blood sugar requiring immediate medical attention.
Product
Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
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-1269-2025·2025-03-12
CircuitGuard Bacterial/Viral Filter Recalled for Plastic Connector Obstruction
Kung Shin Plastics is recalling 30,000 units of CircuitGuard Bacterial/Viral Filter with Elbow (Model SK200FPE/7056) due to plastic occlusion in the connector that prevents airflow and causes ventilation bag malfunction, risking oxygen deprivation and respiratory distress.
Product
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1295-2025·2025-03-12
AURORA Surgiscope System Obturator May Break or Separate
Integra LifeSciences Corp. is recalling AURORA Surgiscope Systems (models ASX15/60 and ASX15/80) because the obturator component may break or separate during surgical use. Healthcare facilities should discontinue use and contact the manufacturer for instructions.
Product
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
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
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-1267-2025·2025-03-12
MIM Radiological Imaging Software Versions May Generate Incorrect Diagnostic Values
MIM radiological software versions 7.2.0-7.2.6 may produce incorrect readings when fusing images with different fields of view, which could affect diagnostic accuracy.
Product
MIM software; System, Image Processing, Radiological
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-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-1291-2025·2025-03-12
DeRoyal Suction Connector Tubing Recalled for Assembly and Function Issues
DeRoyal suction connector tubing in five U.S. states has been recalled because the connector's inner diameter is smaller than the suction canister lid port, making assembly difficult and risking inadequate suction and delayed patient care.
Product
DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1260-2025·2025-03-12
Medtronic MiniMed Insulin Pumps Recalled for Abnormal Delivery During Air Pressure Changes
Medtronic is recalling MiniMed insulin pumps that malfunction during airplane takeoff and landing due to air pressure changes. The defect can cause abnormal insulin delivery, leading to severe hypoglycemia, hyperglycemia, seizure, coma, or death.
Product
MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
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-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-1293-2025·2025-03-12
Alcon Custom Pak surgical packs mislabeled as latex-free despite containing latex
Alcon surgical procedure packs contain latex but are labeled as latex-free, creating risk of allergic reaction for patients with latex sensitivity. The company is recalling 2,511 affected units.
Product
Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-16, 17069-09
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
ModerateFDA (Devices)·Z-1290-2025·2025-03-12
Lumenis Pulse 120H Laser System Charger May Prevent Device Startup
Lumenis recalled three Pulse 120H laser systems due to a charger defect. The charger's initial current can damage AC controller power resistors, preventing the device from powering on.
Product
(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.
Category
Medical Device
Distribution
1 state

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3701–3725 of 13526