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

7026–7050 of 13512

SevereFDA (Devices)·Z-1050-2024·2024-02-28
Dover Foley Catheter Kits Recalled Due to Defective Components
Cardinal Health is recalling 4,620 Dover Foley catheter convenience kits due to components that were recalled by Nurse Assist. The kits, distributed in the US, EMEA, Japan, and Latin America, contain silicone and latex catheters.
Product
Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML D
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1169-2024·2024-02-28
3M Surgical Blade Assembly Recalled for Burn Injury Risk During Use
3M is recalling the Specialty Blade Assembly (REF 9660) used with 3M Surgical Clippers worldwide due to burn risk if the blade overheats during operation. Approximately 52.8 million units affected across all lot codes.
Product
3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1174-2024·2024-02-28
Aquabiliti saline flush syringes recalled for potential sodium chloride content deficiency
MRP, LLC is recalling AQUABILITI AQUASTAT saline flush syringes because they may fail to meet USP standards for sodium chloride content after 12 months.
Product
AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1177-2024·2024-02-28
Azurion 5 X-Ray System Generator May Fail Due to Circuit Short
Philips Azurion 5 X-ray systems with Certeray generators may experience power loss due to a potential short circuit in the power inverter board, potentially delaying or interrupting medical procedures.
Product
Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1145-2024·2024-02-28
Philips Azurion Interventional X-ray Systems framegrabber card may fail to display images
The framegrabber card in Philips Azurion interventional X-ray systems may fail to display diagnostic images properly, potentially delaying procedures.
Product
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067; Azurion 7 B20 722068; Azurion 7 M12 722078 722223;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1179-2024·2024-02-28
Biliary Endoprosthesis Labeling Mismatch Risks Incorrect Device Placement
W.L. Gore's GORE VIABIL Short Wire Biliary Endoprosthesis may be mislabeled regarding drainage holes, risking extended procedures, infections, and unplanned device removal in 24 units distributed in Georgia.
Product
GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1172-2024·2024-02-28
Synapse CV 6 Imaging Software Calculation Error May Cause Misdiagnosis
FUJIFILM Synapse CV 6 medical imaging software may incorrectly calculate left ventricle mass measurements. If used for diagnosis, this calculation error could lead to patient misdiagnosis and incorrect treatment, potentially causing long-term health consequences.
Product
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1150-2024·2024-02-28
Epidural Tray Kits Recalled for Wrong Connector Type
B. Braun Medical recalls 3,890 PERIFIX epidural trays nationwide due to filter straws with incompatible neuraxial connectors instead of standard Luer connectors.
Product
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of devices intended for the administration of an analgesic or anesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anestheti
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1155-2024·2024-02-28
X-ray fluoroscopy system may display abnormal images due to detector board defect
Canon Medical's INFX-8000F X-ray system may display abnormal horizontal stripe patterns due to a manufacturing change in the flat panel detector's internal board, potentially preventing exam completion.
Product
The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user interface and a multi-tasking computer enable the system to fully meet the requirement for optimum image quality, safety, ease of use
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1151-2024·2024-02-28
Philips Allura Xper X-ray systems disk bay component may malfunction
Philips has recalled certain Allura Xper interventional X-ray systems because the disk bay component may fail, potentially preventing system operation and imaging procedures.
Product
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1167-2024·2024-02-28
ESG Cutting Forceps Jaw May Fracture During Use or Inspection
Olympus Corporation of the Americas is recalling ESG PK Cutting Forceps because the jaw may fracture during pre-procedure inspection or during the procedure, posing a potential injury risk.
Product
ESG PK CUTTING FORCEPS, 5MM, 33CM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1173-2024·2024-02-28
OPTIMIZER CCM X11 Implantable Pulse Generator May Fail to Deliver Therapy
The OPTIMIZER model CCM X11 implantable pulse generator may incorrectly detect a charging error and cease delivering cardiac therapy, potentially causing patients to experience heart failure symptoms. A total of 1,469 units are affected.
Product
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1144-2024·2024-02-28
Philips Allura Xper Interventional X-ray System Display and Imaging Malfunction
A framegrabber card malfunction in Philips Allura Xper interventional X-ray systems may cause display failures, preventing proper visualization of medical images and delaying procedures.
Product
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1149-2024·2024-02-28
PERIFIX epidural kits recalled for incompatible filter straw connectors
B. Braun PERIFIX epidural kits contain filter straws with Neuraxial connectors instead of Standard Luer Connections, preventing proper assembly of the kits.
Product
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray (Kit)-A collection of devices intended for the administration of an analgesic or anesthetic agent to the epidural space for the management o
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1178-2024·2024-02-28
Azurion 7 Medical Imaging System May Lose Power During Procedures
Philips Azurion 7 imaging systems may experience power loss due to a potential short circuit in the power inverter, risking delays or termination of diagnostic and surgical procedures.
Product
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1153-2024·2024-02-28
EndoVive Replacement Button Kits mislabeled with incorrect sizing
Boston Scientific is recalling EndoVive Replacement Button Kits due to sizing mislabeling that could cause undersizing and serious complications including tissue damage and sepsis.
Product
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1154-2024·2024-02-28
X-Ray C-Arm System Internal Board Defect Causes Abnormal Images
Canon Medical System X-ray C-arm systems may display abnormal images due to an internal board manufacturing defect, potentially preventing exam completion and requiring patients to be re-examined with alternative equipment.
Product
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and proce
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1152-2024·2024-02-28
Philips Azurion X-ray Systems Disk Bay May Fail and Prevent Imaging
The disk bay component in certain Philips Azurion x-ray systems may fail, potentially preventing diagnostic imaging and delaying procedures. Affected units have been distributed worldwide.
Product
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1147-2024·2024-02-28
Henry Schein Criterion Anti-Fog Earloop Masks Recalled for Equipment Validation Issue
AMD Medicom Inc. is recalling Henry Schein Criterion Anti-Fog Earloop Masks Level 3 (Blue) because the masks were produced on non-validated equipment not included in the product qualification process.
Product
HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1181-2024·2024-02-28
Radiation Oncology Treatment Planning Software VERIQA Calculation Error
PTW-FREIBURG's VERIQA software (versions 2.0 and 2.1) may incorrectly calculate gamma passing rates when users exclude voxels below a dose threshold, potentially displaying false positive dose evaluation results.
Product
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1143-2024·2024-02-28
Ionolux dental cement recalled for manufacturing defect affecting curing
Ionolux dental cement capsules may contain incorrect plungers that prevent proper curing. Affected batches distributed in the US and internationally should not be used.
Product
Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1170-2024·2024-02-28
3M Surgical Clipper Blade Assembly Recalled Due to Burn Risk
3M recalled 764,580 Specialty Blade Assemblies for surgical clippers due to risk of burns from overheating. The blade can reach temperatures exceeding 77°C if left running improperly.
Product
3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1146-2024·2024-02-28
Henry Schein Criterion Level 3 Earloop Masks Recalled for Non-Validated Equipment
AMD Medicom Inc. is recalling Henry Schein Criterion Level 3 Earloop Masks because they were produced on non-validated equipment not included in the initial product qualification.
Product
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1176-2024·2024-02-28
Philips Azurion 3 Surgical Imaging System Recalled for Power Failure Risk
Philips is recalling 14 units of its Azurion 3 surgical imaging system due to a potential short circuit in the power inverter. The defect could cause the device to lose power and fail during surgical procedures.
Product
Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1171-2024·2024-02-28
Cardiology imaging software may calculate heart chamber size incorrectly
Synapse Cardiology PACS software versions 7.0–7.3.0 may calculate left ventricle mass incorrectly, potentially leading to misdiagnosis or wrong treatment plans. Thirteen units have been distributed in the US and Israel.
Product
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images.
Category
Medical Device
Distribution
Distributed nationwide

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7026–7050 of 13512