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

8076–8100 of 13683

HighFDA (Devices)·Z-0208-2024·2023-11-08
POC Analyzer Risk of Erroneous Creatinine Results During Cartridge Startup
Nova Biomedical's Stat Profile Prime Plus POC analyzer may report inaccurate creatinine results during the first 2-4 hours after sensor cartridge installation. Standard quality control checks may not detect these errors.
Product
Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 63368 Stat Profile Prime Plus POC Analyzer (2) PN 63369 Stat Profile Prime Plus POC Analyzer, Remanufactured P/N: 57400, 633
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0200-2024·2023-11-08
RX Imola Clinical Chemistry Analyzer rerun feature may report results incorrectly
RX Imola-IVD Clinical Chemistry Analyzers may report test results incorrectly when handling out-of-range samples due to improper parameter rerun settings. 35 units nationwide are affected.
Product
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0187-2024·2023-11-08
AZUR CX 35 Peripheral Coil System Detachable Recalled for Unsealed Pouch Packaging
MicroVention is recalling 14 units of the AZUR CX 35 Peripheral Coil System due to unsealed pouch packaging that could compromise device sterility. The affected units were distributed across eight states.
Product
AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0213-2024·2023-11-08
Orthopedic knee implant components mislabeled; size mix-up risk
Corin Ltd recalled 3 Unity CR Femur knee implants due to labeling errors. Size 6 implants from batch 529803 may be labeled as size 7, and vice versa.
Product
Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0199-2024·2023-11-08
RX Daytona Plus Clinical Chemistry Analyzer Rerun Settings Malfunction
Randox Laboratories is recalling the RX Daytona Plus (without ISE) IVD Clinical Chemistry Analyzer due to a flaw in rerun settings that may cause incorrect test result reporting.
Product
RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0214-2024·2023-11-08
Unity Total Knee System Inserts May Be Mislabeled With Wrong Size
Corin Ltd is recalling Unity Total Knee System inserts due to a labeling mix-up between batches 529803 and 532405, potentially affecting size 6 and size 7 designations.
Product
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0196-2024·2023-11-08
Siemens X-Ray Systems Software Issue May Cause Patient Misdiagnosis
Siemens Medical Solutions USA is recalling 367 mobile X-ray systems (186 Cios Flow and 181 Cios Spin) due to a software issue that may result in patient misdiagnosis and repeat radiation exposure. Affected units were distributed nationwide.
Product
***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes. Material Number: 11108110 (2)Cios Spin- a mobile x-ray system designed to provide x-ray imaging of
Category
Medical Device
Distribution
Distributed nationwide
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
ModerateFDA (Devices)·Z-0209-2024·2023-11-08
Abbott NT2000iX radiofrequency generator serviced with out-of-tolerance tool
Abbott is recalling 34 NT2000iX radiofrequency generators that were serviced using an out-of-tolerance calibration tool, which may have provided inaccurate measurement results for capacitance failures.
Product
Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
Category
Medical Device
Distribution
0 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-0204-2024·2023-11-08
Coapt ControlSeal Electrode Recalled Due to Burn and Blistering Risk
Coapt LLC is recalling 109 ControlSeal Electrodes due to risk of minor burns or blistering if exposed to direct sunlight or warm temperatures exceeding 12 hours, or if the battery is damaged.
Product
Coapt ControlSeal Electrode, cutaneous EMG Electrode
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0217-2024·2023-11-08
DBS Lead Device Recall: Use By Date Label Discrepancy
Medtronic is recalling a small number of LEAD 3387S-40 deep brain stimulation devices due to discrepancies in the Use By Date printed on the outer package versus the individual product label.
Product
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Category
Medical Device
Distribution
4 states
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-0197-2024·2023-11-08
Quest Medical Recalls Q2 Multiport Intravenous Extension Sets
Quest Medical is recalling 17,700 Q2 Multiport Extension Sets distributed in the US and Canada. The nature of the defect is not detailed in available source documentation.
Product
Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps.
Category
Medical Device
Distribution
19 states
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-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-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-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-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-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-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-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-0060-2024·2023-11-01
Diagnostic Test Strips Recalled for Manufacturing Conformance and Documentation Issues
Universal Meditech Inc. is recalling diagnostic test strips due to Quality System violations and lack of manufacturing documentation. The company is closing and cannot provide post-market surveillance or support.
Product
DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0137-2024·2023-11-01
Maquet Acrobat-i Cardiac Stabilizer Jaw May Break During Surgery
The Maquet Acrobat-i Vacuum Stabilizer System's housing mount jaw may break during cardiac surgery, risking injury to heart tissue, blood vessels, or bypass grafts.
Product
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
Category
Medical Device
Distribution
Distributed nationwide

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8076–8100 of 13683