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

5101–5125 of 27375

SevereFDA (Devices)·Z-1921-2024·2024-06-19
Thoratec HeartMate System Monitor display malfunction in left ventricular assist devices
The Thoratec HeartMate System Monitor is being recalled due to display malfunctions affecting 4,842 devices worldwide. These issues may prevent proper monitoring and device control.
Product
Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2034-2024·2024-06-19
Streptococcal A Rapid Test Kits Recalled for Unauthorized At-Home Distribution
Wondfo USA has recalled Streptococcal A rapid test kits that are being sold for unauthorized at-home and direct-to-consumer use. The kits should not be used outside professional healthcare settings.
Product
Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step Strep A Swab Test, Dealmed Medical Supplies LLC, Strep A Rapid Test Kit, Jant Pharmacal Corporation, Accustrip VALUPAK Strep A Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2033-2024·2024-06-19
Streptococcal A Rapid Test Kits Recalled for Unauthorized Distribution
Wondfo USA is recalling 102,500 units of IMCO Strep A Rapid Test Kits due to unauthorized distribution for at-home, over-the-counter, and direct-to-consumer use.
Product
Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Part Number STP25-IMC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2041-2024·2024-06-19
MRI Systems Power Cable Terminal Block Fire Hazard Recall
Canon Medical MRI systems are being recalled because the terminal block securing the power cable may disconnect, potentially causing electrical arcing and fire. 153 units are affected across the United States and Puerto Rico.
Product
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020)
Category
Medical Device
Distribution
38 states
HighFDA (Devices)·Z-2134-2024·2024-06-19
Stimuplex A Nerve Needles Recalled for Mislabeled DEHP Content
B Braun Medical Inc is recalling over 1.1 million Stimuplex A nerve block needles labeled as DEHP-free, but the adhesive contains traces of DEHP. The mislabeling poses a risk to users who selected the product specifically to avoid DEHP exposure.
Product
Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2039-2024·2024-06-19
Coviden Monoject 60ml Syringes Recalled for Inadvertent Distribution
Coviden Monoject 60ml Luer-Lock syringes were inadvertently distributed despite being quarantined. Mckesson Medical-Surgical is recalling approximately 100 units (lot 330737X) distributed in the United States.
Product
Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Number: 1159851 Cardinal Catalog Number: 8881560125
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2131-2024·2024-06-19
Stimuplex A Injection Needles Recalled for DEHP Mislabeling
B Braun Medical Inc is recalling Stimuplex A injection needles because the devices are labeled as DEHP-free, but the glue used contains traces of DEHP. The recall affects 20,850 units distributed in the US and Canada.
Product
Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2141-2024·2024-06-19
Fresenius AquaA hemodialysis water purification device pressure control malfunction
Fresenius is recalling 4 hemodialysis water purification devices for pressure control malfunctions. When concentrate pressure exceeds the 19.9 bar limit, the device stops supplying water and halts dialysis treatment.
Product
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2038-2024·2024-06-19
EsoFLIP 30mm Balloon Dilation Catheter Recalled for Measurement Inaccuracy
Covidien is recalling EsoFLIP 30mm balloon dilation catheters due to saline conductivity issues that may cause inaccurate esophageal measurements, potentially leading to patient harm.
Product
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2137-2024·2024-06-19
CODMAN EVD BACTISEAL Catheter Sterile Packaging Defect Recall
Integra LifeSciences recalls CODMAN EVD BACTISEAL catheters due to defects in sterile packaging that may compromise product sterility. The defect affects 106 units distributed worldwide.
Product
CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intra
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2139-2024·2024-06-19
Aeos Robotic Digital Microscope recalled for safety mechanism failure
Aesculap Inc is recalling Aeos Robotic Digital Microscope models with Product Code PV010 due to failure of the integrated safety mechanism. The robotic arm may drop more than 10 cm from its original position after the emergency stop button is pressed.
Product
Aeos Robotic Digital Microscope, Product Code: PV010
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2138-2024·2024-06-19
EVD Catheter Sterile Packaging Defect Recall for Intracranial Drainage
Integra LifeSciences is recalling CODMAN BACTISEAL EVD catheters due to external packaging seal defects that may compromise sterility. The recall affects 59 units distributed internationally.
Product
CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2142-2024·2024-06-19
VITROS Immunodiagnostic Calibrators Recalled for Potential Accuracy Bias
Ortho-Clinical Diagnostics is recalling VITROS Anti HBs Calibrators due to potential for positively biased results caused by signal reduction over shelf life. Approximately 481 units were distributed worldwide.
Product
VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2040-2024·2024-06-19
Cardiac SPECT System Recalled for Defective Service Handle Fastening
GE Medical Systems is recalling MyoSPECT cardiac imaging systems due to service handles on internal lead covers that could loosen or release, potentially causing the cover to drop and injure service personnel. The recall affects 133 devices distributed worldwide.
Product
MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2136-2024·2024-06-19
CODMAN BACTISEAL EVD Catheter Set: Sterile packaging defect recalled
Integra LifeSciences is recalling 135 CODMAN BACTISEAL EVD Catheter Sets due to defects in sterile packaging that may compromise product sterility.
Product
CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial p
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2135-2024·2024-06-19
CORI Surgical System Software Error Causes Tracking Array Flickering
The CORI Starter Kit surgical system may experience display flickering from a software tracking error, potentially causing surgical delays during orthopedic procedures.
Product
CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2129-2024·2024-06-19
OMTech Desktop Laser Engraver recalled for missing safety interlocks
Rygel Advanced Machines recalls OMTech Desktop Laser Engravers due to missing safety interlocks and labeling. The devices lack required redundant interlocks and certification labels that prevent accidental laser exposure.
Product
OMTech Desktop Laser Engraver
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2031-2024·2024-06-19
Streptococcal A Rapid Test Kits Recalled for Unauthorized Distribution
Wondfo USA has recalled 170,000 units of Clarity Strep A Rapid Test kits due to unauthorized distribution for at-home use, non-prescription use, over-the-counter use, and direct-to-consumer sales. The recall affects test kits distributed nationwide.
Product
Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Number CD-STP25V
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2133-2024·2024-06-19
Stimuplex A Anesthesia Needles Recalled for Undisclosed DEHP in Glue
B Braun Medical Inc is recalling 108,811 units of Stimuplex A anesthesia needles because the devices are labeled as DEHP-free but the glue contains traces of DEHP.
Product
Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1920-2024·2024-06-12
Pediatric Patient Return Electrode Recalled for Reported Patient Burns
Megadyne Medical Products is recalling its MEGA SOFT Pediatric Patient Return Electrode due to reports of patient burns during electrosurgical use. Approximately 1,270 units distributed worldwide are affected.
Product
MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1878-2024·2024-06-12
Intra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
Arrow International is recalling intra-aortic balloon catheter kits due to potential inflation failure, catheter damage, and helium loss that could cause serious health consequences.
Product
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1879-2024·2024-06-12
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
Arrow International is recalling its UltraFlex Intra-Aortic Balloon Catheter Kit because of infrequent device malfunction that could lead to serious health consequences. 44,807 units are affected worldwide.
Product
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1880-2024·2024-06-12
Arrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
The FDA recalled 3,138 Arrow Ultra 8 intra-aortic balloon catheter kits globally due to potential balloon inflation failure and helium pathway damage that could compromise critical cardiac support.
Product
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1877-2024·2024-06-12
Sevoflurane Vaporizer Component Recall Due to Hydrogen Fluoride Degradation
Getinge's sevoflurane vaporizer component may degrade into hydrogen fluoride, posing inhalation and skin exposure risks to healthcare workers and patients. The FDA Class I recall affects 120 units distributed across six U.S. states.
Product
Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1949-2024·2024-06-12
Medical device recall: HA FlexTrak patient transport trolley oil leak hazard
Philips is recalling the HA FlexTrak patient transport trolley due to potential oil leaks from the hydraulic system that create slipping and falling hazards. Approximately 100 units have been distributed worldwide.
Product
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412
Category
Medical Device
Distribution
Distributed nationwide

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5101–5125 of 27375