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

5151–5175 of 27364

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-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-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-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
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-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-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-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
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
HighFDA (Devices)·Z-1943-2024·2024-06-12
Arial Emergency Mobile App Restarts Cause Alert Overload and Call Failures
The Arial mobile application experiences frequent restarts on iOS 17.4 and 17.5, causing alert overload, communication failures, and offline status in healthcare facilities.
Product
Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a component of the Arial Emergency and Nurse Call System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2023-2024·2024-06-12
BD SARS-CoV-2 Reagent Kits Recalled for False Negative Test Results
Becton Dickinson is recalling 2,061 kits of BD SARS-CoV-2 Reagents for BD MAX Systems because they may produce false negative results due to decreased enzyme activity. The kits were distributed nationwide and internationally.
Product
BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1937-2024·2024-06-12
Medline Disposable Syringes Recalled for Inaccurate Volume Delivery
Medline is recalling 25.2 million Luer Lock disposable syringes because testing documentation does not confirm they deliver accurate volumes across their claimed capacity. The inaccuracy may pose a risk to patient health.
Product
MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1940-2024·2024-06-12
Synchro SELECT Guidewires may have PTFE coating damage
Stryker Neurovascular recalls certain lots of Synchro SELECT Guidewires due to PTFE coating damage that may occur when using a backloading technique. The damage is caused by sharper-than-intended edges on older introducer versions.
Product
The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014in. The guidewires are compatible with existing microcatheters used in common procedures s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1948-2024·2024-06-12
HA FlexTrak Patient Transport Device Oil Leak Poses Slipping Hazard
Oil may leak from the HA FlexTrak patient transport device when the hydraulic pedal is pressed, creating a potential slipping or falling hazard on the floor.
Product
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2028-2024·2024-06-12
Philips Tempus LS-Manual Defibrillator may malfunction from electrical interference
Simultaneous ECG measurements with multiple devices can cause electrical interference that may prevent this defibrillator from functioning properly. The recall affects 1,745 units distributed nationwide.
Product
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1950-2024·2024-06-12
Medical device trolley recalled due to oil leak causing slipping hazard
Philips HA FlexTrak II patient transport trolleys may leak hydraulic oil onto the floor when pressed, creating a slip and fall hazard. About 590 units are affected worldwide.
Product
HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1935-2024·2024-06-12
LOSPA Patella Knee Component Recalled for Unsupported Expiration Date
CORENTEC's LOSPA Patella Component knee implants are recalled due to an unsupported 10-year expiration date. Thirty-five units were distributed nationwide.
Product
LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2021-2024·2024-06-12
GlideScope Core 15-inch Monitor Recalled for Potential Image Loss Software Issue
Verathon is recalling GlideScope Core 15-inch monitors due to software issues causing potential image loss or degradation. Approximately 2,568 units were distributed across the US and internationally.
Product
Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor
Category
Medical Device
Distribution
49 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
HighFDA (Devices)·Z-1938-2024·2024-06-12
Medline Luer Slip Syringes Recalled for Inaccurate Volume Delivery
Medline Industries is recalling over 5 million Luer Slip disposable syringes because testing documentation does not confirm they deliver accurate volumes across their claimed capacity range. This poses a risk to patient health.
Product
MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1942-2024·2024-06-12
WAVi Research EEG Desktop System recalled due to FDA Warning Letter
WAVi Co. is recalling 281 units of the WAVi Research EEG Desktop System following an FDA-issued Warning Letter. The company requested the return of components due to closure of their research study.
Product
WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rate Variability (HRV) Ear Clips. The system kit also incorporates use of the firm's cleared EEG analysis technology (the WAVi SCAN EEG System a
Category
Medical Device
Distribution
31 states
HighFDA (Devices)·Z-1998-2024·2024-06-12
Vascular graft recall due to slider mechanism separation defect
Atrium Medical is recalling ADVANTA VXT vascular grafts due to separation of the slider mechanism. The defect affects over 53,000 units distributed worldwide and could compromise graft function.
Product
ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1944-2024·2024-06-12
Alaris Pump Infusion Set Drip Chamber May Detach During Use
A defective drip chamber in the Alaris Pump Infusion Set may detach from the tubing, potentially delaying treatment or causing unintended exposure to medications. BD is recalling approximately 11,300 units distributed across the US and Canada.
Product
Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fluids, medication, blood and blood products.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2017-2024·2024-06-12
Vascular graft device recalled due to swivel rod separation
Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reported separation of the swivel rod from the core component. This defect could compromise device function.
Product
FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1936-2024·2024-06-12
Medline Syringes Recalled Due to Leaks, Breakage, and Quality Issues
Medline Industries is recalling over 2.3 million syringes due to identified leaks, breakage, and quality issues that may pose risks to patient health. The affected syringes were distributed nationwide and internationally.
Product
Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW PR, Item Number: DYNJSYRPP20B; c) SYRINGE 20ML RED L/L LOW PRESS, Item Number: DYNJSYRPP20R; d) SYRINGE 10ML RED L/L LOW PR, Item Number: DYN
Category
Medical Device
Distribution
Distributed nationwide

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5151–5175 of 27364