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

5626–5650 of 13543

HighFDA (Devices)·Z-2466-2024·2024-08-14
SIGNA PET/MR diagnostic imaging system poses implant overheating risk
GE HealthCare recalled SIGNA PET/MR systems with specific software versions due to a configuration issue that can cause RF energy to exceed safety limits, potentially overheating MR-conditional implants.
Product
SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2507-2024·2024-08-14
Integra Recalls TruDi NAV Suction Instruments for Calibration Error
Integra LifeSciences has recalled 265 TruDi NAV Suction Instruments due to incorrect calibration. The miscalibrated units may display inaccurate position information during surgical navigation procedures.
Product
TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skull base surgery
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-2467-2024·2024-08-14
Discovery MR450 MRI System Can Overheat Implants Under Specific Conditions
GE Discovery MR450 MRI systems with certain software versions can cause implant overheating under specific scanning conditions. 23 units worldwide require firmware updates.
Product
Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2496-2024·2024-08-14
Automated Medication Dispensing Cabinet Software Issue with Incorrect Bin Labeling
BD PYXIS MEDBANK automated medication dispensing cabinets with software version 3.9.1.9 may generate incorrect bin location labels during restocking. This could cause medications to be placed in wrong storage locations.
Product
BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2511-2024·2024-08-14
Philips IntelliVue Patient Monitors Shipped with Missing Monitoring Capabilities
Philips IntelliVue patient monitors shipped or updated with software that removes monitoring capabilities, potentially delaying or resulting in incorrect treatment.
Product
IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2508-2024·2024-08-14
Philips IntelliVue Patient Monitor Software Missing Critical Entitlements
Philips IntelliVue Patient Monitor models with software L.x and M.x lack critical monitoring capabilities due to a software update. This could result in incorrect or delayed patient treatment.
Product
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2489-2024·2024-08-14
BD PYXIS MEDBANK Automated Cabinet May Print Incorrect Medication Bin Labels
A software issue in the BD PYXIS MEDBANK automated medication dispensing cabinet can cause incorrect bin labels to be printed for restock operations. This could lead to medication administration errors affecting patient safety.
Product
BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2523-2024·2024-08-14
Biopsy Drape Pack sterilization failure recall from American Contract Systems
American Contract Systems is recalling 224 Biopsy Drape Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised the sterility of affected units. Lot 981241 distributed in CA, KS, ME, MN, MO, NE, and SD is affected.
Product
American Contract Systems Biopsy Drape Pack convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2514-2024·2024-08-14
Diagnostic Test Kits Recalled for False Vibrio Results With Certain Transport Medium
BioFire Diagnostics is recalling gastrointestinal diagnostic test kits due to false positive Vibrio results when used with certain transport mediums.
Product
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnost
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2509-2024·2024-08-14
Philips IntelliVue Patient Monitors with disabled monitoring software options
Philips IntelliVue Patient Monitors (MX400/450/500/550) with software versions L.x or M.x lack required monitoring capabilities due to removed software entitlements. The missing features could lead to incorrect or delayed patient treatment.
Product
IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, an
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2479-2024·2024-08-14
GE SIGNA Prime MR system can exceed RF safety limits in Low SAR mode
GE Medical Systems is recalling 72 SIGNA Prime MR imaging systems worldwide. Under specific imaging conditions, the systems can exceed prescribed radiofrequency safety limits, potentially causing MR conditional implants to overheat.
Product
SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2475-2024·2024-08-14
GE SIGNA MR355 MRI System Recalled for Potential Implant Overheating Risk
GE SIGNA MR355 MRI systems running software versions SV25.5 or SV25.6 may cause implant overheating in certain scanning conditions. Risk occurs when using specific imaging sequences with the Optimized T2 FLAIR feature disabled.
Product
SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2491-2024·2024-08-14
BD PYXIS MEDBANK Cabinet Software Causes Incorrect Medication Labels
FDA recall of BD PYXIS MEDBANK automated medication dispensing cabinets due to a software defect that prints incorrect bin information on restock labels, potentially leading to medication identification errors.
Product
BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2483-2024·2024-08-14
MRI System Software Error Can Overheat Patient Implants
GE Medical Systems recalled three SIGNA 7.0T MRI systems due to a software error that can exceed preset safety limits during imaging, potentially overheating implants in patients under certain conditions.
Product
SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2534-2024·2024-08-14
Philips Azurion X-ray System: Potential Loss of Imaging Functionality
The Philips Azurion Interventional Fluoroscopic X-ray System may lose imaging functionality or experience longer restart times. The FDA is recalling approximately 3,011 units of this device worldwide.
Product
Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, car
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2488-2024·2024-08-14
BD PYXIS Automated Medication Cabinet Software Label Error Affects 11 Units
CareFusion's BD PYXIS medication dispensing cabinet with software version 3.9.1.9 may print incorrect bin labels during restocking, potentially leading to wrong medication dispensing. Eleven units distributed nationwide are affected.
Product
BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2465-2024·2024-08-14
GE Discovery MR750w MRI System Software May Overheat Implants
GE HealthCare is recalling certain Discovery MR750w 3.0T MRI systems where the magnetic field strength (B1+RMS) can exceed the prescribed limit during specific imaging sequences, potentially causing overheating of MR-conditional implants.
Product
Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2521-2024·2024-08-14
Surgical Convenience Kits Recalled for Potential Sterilization Failure
American Contract Systems is recalling three surgical convenience kits due to potential sterilization failure from insufficient aeration time during processing.
Product
American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2477-2024·2024-08-14
GE Brivo MR355 MRI System Software Issue Causing Implant Overheating Risk
GE HealthCare has recalled certain Brivo MR355 MRI systems due to a software issue that can cause overheating of implanted medical devices in specific imaging scenarios. Approximately 375 units have been affected worldwide.
Product
Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2486-2024·2024-08-14
Automated dispensing cabinet software issue causes incorrect medication bin labels
CareFusion is recalling 232 automated medication dispensing cabinets due to a software issue that may print incorrect medication bin labels, potentially causing medication dispensing errors.
Product
BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2480-2024·2024-08-14
MRI System Software Issue Can Overheat Implanted Medical Devices
GE HealthCare recalled 23 SIGNA Victor MRI systems due to a software issue that can cause MR conditional implants to overheat. The defect occurs under specific imaging mode and configuration combinations.
Product
SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2494-2024·2024-08-14
Medication Dispensing Cabinet Software Defect Causes Incorrect Bin Labels
BD PYXIS automated medication dispensing cabinets contain a software issue that may print incorrect bin locations on restock labels. This could result in medications being placed in the wrong bin during restocking.
Product
BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2459-2024·2024-08-14
SIGNA Architect MRI System Software Can Exceed Implant Heating Limits
GE Medical Systems is recalling SIGNA Architect MRI systems in which software may allow B1+ radiofrequency exposure to exceed user-prescribed limits during certain T2 FLAIR imaging sequences, risking MR-conditional implant overheating.
Product
SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2532-2024·2024-08-14
FDA Recalls CryoPatch Cardiac Tissue Grafts Due to Invalid Test Results
Artivion has recalled CryoPatch SG cardiac tissue patches used in pulmonary surgeries due to approval and release with invalid test results. Patients who received implants should consult their healthcare provider.
Product
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2520-2024·2024-08-14
Medical Procedure Kit Recalled Over Potential Sterilization Compromise
American Contract Systems is recalling Special Procedure Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised sterility. Distributed in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.
Product
American Contract Systems Special Procedure Pack convenience kit
Category
Medical Device
Distribution
Distributed nationwide

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5626–5650 of 13543