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

16176–16200 of 31567

HighFDA (Drugs)·D-0154-2024·2023-12-27
Nystatin bulk powder recall due to incorrect assay strength label
Fagron, Inc. is recalling Nystatin 5BU bulk powder for prescription compounding due to an incorrect assay strength label. The product was distributed to pharmacies and repacker/relabelers in the United States and Canada.
Product
NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3
Category
Drug
Distribution
0 states
HighFDA (Devices)·Z-0581-2024·2023-12-27
Exactech Novation Hip System Recalled for Vacuum Seal Loss
Exactech is recalling the Novation Hip System due to loss of vacuum in the sterile packaging. The company has received complaints about this defect affecting 4 devices.
Product
Exactech Novation Hip System, Catalog Numbers: 134-36-45
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0585-2024·2023-12-27
Exactech Truliant Knee System Recalled Due to Vacuum Bag Failure
Exactech recalls certain Truliant Knee System units due to loss of vacuum in the inner vacuum bag. The affected units were distributed across multiple U.S. states and international locations.
Product
Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-35-3511, h) 02-022-35-4511, i) 02-022-44-3512, j) 02-022-47-2509, k) 02-022-51-4519
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0608-2024·2023-12-27
RAPIDPoint 500 Measurement Cartridge Sodium Sensor May Cause Measurement Error
Siemens RAPIDPoint 500 cartridges may produce inaccurate sodium measurements in blood samples, potentially delaying diagnosis or causing inappropriate treatment. The sodium sensor may show a negative bias, affecting patient care.
Product
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0559-2024·2023-12-27
Philips Azurion Ceiling-Mount Systems Rotation Cover May Fall
Philips is recalling Azurion ceiling-mount imaging systems because a rotation cover may fall if the L-arm collides with hospital equipment, potentially causing injury or affecting sterilization.
Product
Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0567-2024·2023-12-27
AC Power Adapter for LIFEPAK 15 Defibrillator May Fail to Charge or Power On
AC power adapters for LIFEPAK 15 Monitor/Defibrillators may fail to charge batteries or power on the device. Physio-Control is recalling 18,732 units manufactured between November 2021 and April 2023.
Product
AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0609-2024·2023-12-27
RAPIDPoint 500 Measurement Cartridge Sodium Sensor Negative Bias Risk
Siemens RAPIDPoint 500 measurement cartridges may produce inaccurate sodium readings, risking delayed diagnosis of dangerous electrolyte imbalances or unnecessary treatment.
Product
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491449
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0566-2024·2023-12-27
CardioQuip Modular Cooler-Heater Model MCH-1000(m) Recalled for Bacterial Contamination
CardioQuip LLC is recalling 2 units of its Model MCH-1000(m) Modular Cooler-Heater due to potential bacterial contamination that could result in patient infection. The affected devices are distributed in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska.
Product
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0576-2024·2023-12-27
Philips Inclusive CT Systems: Software Errors in Image Display and Interpretation
Philips North America is recalling 330 Philips Inclusive CT imaging systems due to software issues causing incorrect image display, errors in image interpretation, and patient exposure to incorrect images and system functions during clinical use.
Product
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment suppor
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-0589-2024·2023-12-27
Acrobat-i Vacuum Positioner System Recalled for Positioner Arm Locking Failure
Maquet Cardiovascular is recalling the Acrobat-i Vacuum Positioner System because the positioner arm may fail to tighten or lock during normal use, which could affect surgical positioning.
Product
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0560-2024·2023-12-27
Roche Cobas Interface Module Firmware May Cause Delayed Sample Processing
Inpeco is recalling firmware versions for the Roche Cobas 8000 and PRO Interface Module that may cause delayed sample tube processing in laboratory automation systems.
Product
Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions: FLX-247-0
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0603-2024·2023-12-27
Ice Cream Bar Recalled for Undeclared Food Dyes
La Michoacana Rompope ice cream bars are being recalled due to undeclared Yellow #5, Yellow #6, and Red #40. The product was distributed only in Florida.
Product
ICE CREAM BAR, MICHOACANA, es...natural, ROMPOPE, Net. Wt. 6 Fl. Oz., Packaged in a plastic bag. Frozen.
Category
Food
Distribution
0 states
ModerateFDA (Devices)·Z-0602-2024·2023-12-27
ZEUS ELISA Parvovirus B19 Test Kits Recalled for Unapproved Modification
Zeus Scientific is recalling 296 ZEUS ELISA Parvovirus B19 IgG Test System kits distributed in seven US states because an unapproved modification was made to the test reagent without FDA approval.
Product
ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0568-2024·2023-12-27
ACMI Roller Bar Electrodes Recall Due to Incorrect Pouch Labeling
Olympus Corporation of the Americas is recalling ACMI Roller Bar Electrodes due to incorrect pouch labels. Pouches are mislabeled as Right Angle Cutting Loop Electrodes but contain the correct Roller Bar product.
Product
ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-0595-2024·2023-12-27
CARDIOHELP-i Heart-Lung Support System not properly tested for leakage current
The CARDIOHELP-i Heart-Lung Support System was not properly tested to measure leakage current, an electrical safety concern. The FDA is recalling 1,594 units distributed worldwide.
Product
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numb
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0564-2024·2023-12-27
Vero Biotech GENOSYL DS cassette recalled for manufacturing flow defect
Vero Biotech is recalling GENOSYL DS Generation 3 cassettes that failed to meet manufacturing flow specifications. The recall affects 2 units distributed in Arizona and Florida.
Product
VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point of use
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0586-2024·2023-12-27
Exactech knee replacement inserts recalled for vacuum seal loss
Exactech is recalling Truliant and Activit-E knee replacement inserts for loss of vacuum in storage packaging. The defect was identified in 3 complaints involving 4 devices, with no reported injuries.
Product
Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-0035, d) 02-023-02-0038, e) 02-024-35-1512, f) 02-024-35-1515, g) 02-024-35-1519, h) 02-024-35-2010, i) 02-024-35-2013, j) 02-024-35-2015, k) 02-02
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-0603-2024·2023-12-27
ZEUS ELISA Parvovirus B19 Test Kits Recalled for Unapproved Modification
Zeus Scientific recalls ZEUS ELISA Parvovirus B19 IgM test kits due to an unapproved modification to the test conjugate that was implemented without FDA review and approval.
Product
ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
Category
Medical Device
Distribution
7 states
SevereCPSC·24064·2023-12-21
Brandline HEAO 4-in-1 High Chairs Recalled for Suffocation and Laceration Risks
Brandline is recalling about 820 HEAO 4-in-1 high chairs sold on Amazon from November 2022 through September 2023 because they pose suffocation, finger laceration, and entrapment hazards. One child has suffered a laceration requiring medical attention.
Product
HEAO 4-in-1 High Chairs
Category
Consumer Product
Distribution
Distributed nationwide
SevereCPSC·24065·2023-12-21
Hover-1 Helix Hoverboards Recalled Due to Fire Hazard
About 25,000 Hover-1 Helix hoverboards in Camouflage and Galaxy colors are recalled because their lithium-ion batteries can overheat and catch fire. Three fires have been reported, along with smoke inhalation injuries and property damage.
Product
Hover-1 Helix hoverboards (Camouflage and Galaxy colors only)
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·24066·2023-12-21
FeraDyne Outdoors Recalls Rhino Tree Stands Due to Fall Hazard
FeraDyne Outdoors is recalling about 50,000 Rhino Tree Stands because the safety harness stitching can rip, creating a fall hazard. No injuries have been reported.
Product
Rhino Tree Stands
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·24732·2023-12-21
Pella Architect Series Casement Windows Recalled for Detachment Injury Hazard
Pella Corporation is recalling approximately 12,000 Architect Series Casement Windows because the window sash can detach from the frame and fall, creating an injury risk. The company has received one report of detachment but no injuries have been reported.
Product
Pella Architect Series Casement Windows
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·24067·2023-12-21
Klein Tools and Blackfire Portable Power Stations Recalled for Fire and Burn Hazards
Klein Tools and Blackfire portable rechargeable power stations are being recalled because their internal inverter boards can overheat, creating fire and burn hazards. Consumers should stop using the units and return them to their original point of purchase.
Product
Portable Rechargeable Power Stations
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·24737·2023-12-21
Litti City and Litti Pritti Dress-Up Playsets and Prextex Slime Eggs Recalled for Phthalate and Lead Violations
Litti City Premier Doctor and Teacher Purse playsets, Litti Pritti Stylist Handbag set, and Prextex Slime Eggs are recalled for containing phthalates and lead exceeding federal safety standards. No injuries have been reported.
Product
Litti City Premier Doctor Playset and Teacher Purse Set, Litti Pritti Stylist Handbag Set, and Prextex Slime Eggs
Category
Consumer Product
Distribution
Distributed nationwide
ModerateCPSC·24068·2023-12-21
TJX Foldable Wood and Rope Bistro Set Chairs Recall Due to Fall Hazard
TJX is recalling about 29,000 foldable wood and rope bistro set chairs because the wooden frame can break or collapse when occupied, creating a fall hazard. The company has received eight reports of frame breakage, including six reports of minor injuries such as bruising and ankle strain.
Product
Foldable wood and rope bistro set chairs
Category
Consumer Product
Distribution
Distributed nationwide

How to read this listing

Filters

16176–16200 of 31567