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

8826–8850 of 40007

ModerateFDA (Devices)·Z-0210-2024·2023-11-08
Endoscopic Vessel Harvesting System Recalled for Incorrect Outer Box Packaging
Vasoview 6 Pro endoscopic vessel harvesting systems were packaged in incorrect outer boxes displaying artwork for a different device (Vasoview Hemopro 2). The inner labels and product documentation are correct.
Product
Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview Hemopro 2 (HP2).
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-0205-2024·2023-11-08
Pediatric Tracheostomy Tube Recalled Due to Incorrect Box Expiration Date Label
Smiths Medical recalls a pediatric tracheostomy tube because the outer box shows an incorrect expiration date (3/17/2021) while the actual product has the correct date (3/17/2026). The discrepancy could cause confusion about product validity.
Product
Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-0212-2024·2023-11-08
Hillrom Progressa+ Hospital Beds Recalled for Static Electricity Risk
Hillrom Progressa+ hospital beds (499 units) are being recalled due to potential static electricity buildup that could cause mild shock to operators during transport. The affected units were distributed nationwide.
Product
HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A001973, and P7501A001974
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0149-2024·2023-11-01
Monoject 35 mL Syringe Recalled for Pump Incompatibility Issues
Cardinal Health is recalling 1,097,048 Monoject 35 mL syringes due to demonstrated compatibility and recognition issues with infusion pumps. The affected units were distributed nationwide.
Product
Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0145-2024·2023-11-01
Monoject 1 mL Tuberculin Syringes Recalled for Infusion Pump Compatibility Issues
Cardinal Health recalls approximately 3.1 million Monoject 1 mL Tuberculin Syringes due to demonstrated compatibility and recognition issues with syringe infusion pumps. Nationwide distribution affected.
Product
Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0123-2024·2023-11-01
B. Braun Infusomat Large Volume Pump may stop delivering medication due to false alarm
The Infusomat Large Volume Pump may incorrectly sound an occlusion alarm and stop delivering high-risk medications, potentially causing serious complications.
Product
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0148-2024·2023-11-01
Monoject 20 mL Syringes Recalled for Infusion Pump Compatibility Issues
Cardinal Health is recalling 4.9 million Monoject 20 mL Luer-Lock syringes due to compatibility and recognition issues with infusion pumps. Affected lot numbers from 2022 and 2023 were distributed nationwide.
Product
Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0146-2024·2023-11-01
Monoject 6 mL Syringes Recalled Due to Infusion Pump Incompatibility
Cardinal Health is recalling Monoject 6 mL Luer-Lock syringes (approximately 3.9 million units) nationwide due to demonstrated recognition and compatibility issues with syringe infusion pumps.
Product
Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0150-2024·2023-11-01
Monoject 60 mL Syringes Recalled for Infusion Pump Compatibility Issues
Cardinal Health is recalling 457,200 Monoject 60 mL Luer-Lock tip syringes due to demonstrated compatibility issues with certain infusion pump systems. The affected syringes may fail to function correctly with these pumps.
Product
Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0111-2024·2023-11-01
ResMed Astral ventilators recalled for power loss and failed alarms
ResMed recalls Astral ventilators due to a battery fault that can cause sudden power loss. The backup alarm system may fail to alert users due to supercapacitor degradation.
Product
Astral 100 and Astral 150 ventilators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0147-2024·2023-11-01
Monoject 12 mL Syringes Recalled for Infusion Pump Compatibility Issues
Cardinal Health recalls 3 million Monoject 12 mL Luer-Lock syringes due to demonstrated compatibility issues with syringe infusion pumps that may affect medication delivery.
Product
Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0124-2024·2023-11-01
Infusomat Large Volume Pump False Occlusion Alarm May Interrupt Medication
B. Braun's Infusomat Large Volume Pump battery pack may sound a false occlusion alarm, causing the device to stop pumping. This interruption of high-risk medications can lead to hemodynamic instability and serious medical consequences.
Product
8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0161-2024·2023-11-01
Medtronic Grafton DBM Crunch surgical implant packaging inspection defect
Medtronic is recalling Grafton DBM Crunch bone matrix surgical implants due to potential packaging defects in the outer Tyvek pouch. An inspection step may not have been completed according to requirements.
Product
Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0050-2024·2023-11-01
Pregnancy test strips recalled due to manufacturing documentation gaps
Universal Meditech Inc. is recalling To Life hCG pregnancy test strips because the company is ceasing operations and cannot verify manufacturing compliance. The firm cannot provide documentation of manufacturing standards, storage conditions, or post-market safety monitoring.
Product
To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0049-2024·2023-11-01
Pregnancy Test Recalled for Unverified Manufacturing Compliance and Firm Closure
Universal Meditech Inc. is recalling the Am I Pregnant? One Step HCG Pregnancy Test because the company is going out of business and cannot verify manufacturing compliance or provide quality system documentation.
Product
Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0142-2024·2023-11-01
Radiological imaging system may display wrong patient information in workflow
GE Healthcare's Centricity Universal Viewer Workflow Manager may display exam information for a different patient when third-party reporting applications launch exams. The mismatch could lead to incorrect patient identification.
Product
Centricity Universal Viewer Workflow Manager, Image processing radiological system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0143-2024·2023-11-01
Medical imaging system may display wrong patient information
GE Healthcare's Universal Viewer Workflow Manager medical imaging software may show the wrong patient's information when third-party reporting applications are used. This data mismatch could cause confusion during medical procedures.
Product
Universal Viewer Workflow Manager, Image processing radiological system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0176-2024·2023-11-01
Pediatric Heart SJH Device Recall Due to Improper Sterilization
American Contract Systems recalls Pediatric Heart SJH components exposed to improper sterilization, risking functionality loss and reduced drug efficacy.
Product
Pediatric Heart SJH, REF SJPH34K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0138-2024·2023-11-01
Radiological Imaging Software May Display Images from Multiple Patients in Single Study
GE Healthcare is recalling Centricity PACS-IW radiological imaging software versions V3.7.x through 3.7.3.9 SP3 because images from different patients may appear together in a single study, risking patient misidentification.
Product
Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0152-2024·2023-11-01
Preat Neodent Dental Healing Abutment Recalled for Dimensional Defect
Preat Corp is recalling Preat REF 9007121 Neodent GM x 2mm Healing Abutments due to a dimensional condition that may create a gap between the abutment and implant, potentially allowing microleakage. Affected devices were distributed in multiple US states.
Product
Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0175-2024·2023-11-01
IV catheter components recalled for improper sterilization exposure
American Contract Systems is recalling CVS PCSU SJH IV catheter and adhesive components due to improper ethylene oxide sterilization. The components may have reduced functionality or elevated chemical residuals.
Product
CVS PCSU SJH, REF SJCV48J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0155-2024·2023-11-01
SOZO Bilateral Arm L-Dex Software inadequate lymphedema detection sensitivity
Impedimed's SOZO Bilateral Arm L-Dex Software (versions 4.1 and 5.0) has inadequate sensitivity for detecting early lymphedema, which could delay treatment. The FDA is recalling 354 units distributed nationwide.
Product
SOZO Bilateral Arm L-Dex Software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0127-2024·2023-11-01
TruDi Navigation System position discrepancy during ENT surgery
A surgical navigation system used in ENT procedures may display incorrect curette tip positions, potentially causing delayed surgery, cerebrospinal fluid leaks, vision loss, or skull damage. The recall affects 141 units across 30 US states.
Product
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Category
Medical Device
Distribution
30 states
HighFDA (Devices)·Z-0179-2024·2023-11-01
Robotics Pack I.V. Catheter and Adhesive Recalled for Sterilization Defect
American Contract Systems is recalling its Robotics Pack (56 cases) due to improper sterilization of IV catheter and adhesive components. The devices may have lost functionality or drug efficacy and may contain excessive ethylene oxide residuals.
Product
Robotics Pack, REF SSRO22D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0162-2024·2023-11-01
Grafton DBM Demineralized Bone Matrix Recall Due to Sterile Packaging Inspection Failure
Medtronic is recalling 77 units of Grafton DBM (Flex) due to a potential failure to perform required inspection of the outer Tyvek sterile pouch. Affected units may not meet sterile packaging standards.
Product
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Category
Medical Device
Distribution
0 states

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8826–8850 of 40007