The Recall Desk

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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

12026–12050 of 13837

  • HighFDA (Devices)·Z-0891-2022·2022-04-13

    Abbott ARCHITECT STAT myoglobin calibrators recalled for calibration failure

    Abbott is recalling 402 kits of ARCHITECT STAT myoglobin calibrator that failed stability testing and may produce out-of-specification calibration results. The affected calibrators could impact the accuracy of myoglobin measurements used in clinical diagnostics.

    Product
    ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0737-2022·2022-04-13

    Philips StentBoost Live imaging system acquisition malfunction recall

    Philips Healthcare is recalling the StentBoost Live R2.0 application due to a software configuration error. The imaging system fails to stop image acquisition automatically, continuing indefinitely while the pedal is pressed instead of stopping after 40 images.

    Product
    Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0874-2022·2022-04-13

    Philips Allura and Azurion X-ray systems may display incorrect previous images

    Philips Allura and Azurion X-ray systems running StentBoost Live R2.0 may display images from previous scans or other patients due to a software defect. 338 units are affected and globally distributed.

    Product
    Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0863-2022·2022-04-13

    Stradis Medical Anesthesia Kit Recalled Due to Sterility Breach Risk

    Stradis Medical is recalling Lum Lam Custom Pack Anesthesia Kits because the outer bag may be perforated or torn, potentially compromising the kit's sterility. Two lot numbers are affected.

    Product
    Lum Lam Custom Pack - Anesthesia Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0878-2022·2022-04-13

    DeRoyal ST Neonatal Dressing Change Kit recalled for unvalidated manufacturing test methods

    DeRoyal Industries is recalling 400 DeRoyal ST Neonatal Dressing Change Kits due to uncertain validation of manufacturing test methods. The recall affects kits distributed to healthcare facilities in Florida, New Jersey, and Tennessee.

    Product
    DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0868-2022·2022-04-13

    X-ray System Models Recalled for Potential Radiation Dose Exceeding Standards

    Shimadzu Medical Systems recalls 176 SonialVision G4 X-ray systems that may emit radiation doses exceeding federal standards in some fluoroscopic mode cases. No injuries have been reported.

    Product
    MODEL: X-RAY TV SYSTEM SONIALVISION G4
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0861-2022·2022-04-13

    Defibrillator devices unapproved for US market recalled by FDA

    Remote Diagnostic Technologies recalls Tempus LS defibrillators not approved for US distribution. Two units were distributed in Illinois and Kansas.

    Product
    Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0881-2022·2022-04-13

    Philips HeartStart HS1 AED Pads: Potential Gel Separation Defect

    Philips is recalling adult Smart PADS cartridges for HeartStart HS1 defibrillators due to potential gel separation from the pad backing. Affected pads may have reduced gel contact, potentially affecting device performance.

    Product
    Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2022·2022-04-13

    SyncVision Systems cardiac imaging measurement error in same-session workflow

    SyncVision cardiac imaging systems may display incorrect measurements during same-session procedures if workflow steps are performed out of order, potentially affecting patient treatment.

    Product
    SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0865-2022·2022-04-13

    Anterior Hip Surgical Kit Recall Due to Potential Sterility Breach

    Stradis Medical is recalling Anterior Hip Pack surgical kits due to perforated or torn outer bags that may compromise sterility. No illnesses have been reported.

    Product
    Anterior Hip Pack - Surgical Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0883-2022·2022-04-13

    Abbott Alinity m HBV Device Misquantitation of Negative Samples

    Abbott Molecular recalled Alinity m HBV Application Specification Files due to potential for incorrect high quantitation results on negative samples, which could affect test accuracy for hepatitis B virus detection.

    Product
    Alinity m HBV Application Specification File (US and CE)
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0880-2022·2022-04-13

    DeRoyal DEXMED Access Center Tray Recalled for Manufacturing Test Validation Uncertainty

    DeRoyal Industries is recalling 1,360 DEXMED ACCESS CENTER TRAY kits with Prevantics antiseptic swabs due to uncertain validation of manufacturing test methods. The affected kits were distributed in Florida, New Jersey, and Tennessee.

    Product
    DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0877-2022·2022-04-13

    Panther Fusion GBS Assay Cartridges Recalled for False Negative Results

    Hologic is recalling 2,061 Panther Fusion GBS Assay Cartridges because samples at or near the limit of detection may produce false negative results, risking missed diagnosis of group B streptococcus infection.

    Product
    Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-0871-2022·2022-04-13

    Draeger Babylog VN500 Ventilators Recalled for Cybersecurity Vulnerability

    Draeger Medical is recalling Babylog VN500 ventilators for neonatal and pediatric patients due to cybersecurity vulnerabilities. The devices are not equipped against potential cyber threats.

    Product
    Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0857-2022·2022-04-13

    Signa 1.5T MRI System Recall: Potential Horizontal Image Reversal

    GE Healthcare is recalling 10 Signa 1.5T TwinSpeed MRI systems worldwide due to a potential defect where magnetic resonance images may be flipped left to right.

    Product
    Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0898-2022·2022-04-13

    Medline Excelsior Medical Sterile Saline Flush Syringes Recalled for Sterility Failure

    Medline Industries is recalling 7,800 Excelsior Medical 10mL Sterile Field Saline Flush syringes due to sterility failure of the exterior syringe surface, which may prevent the product from being safely used on a sterile field.

    Product
    Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0887-2022·2022-04-13

    Surgical drive mechanism recalled due to corrosion risk

    Maquet Cardiovascular is recalling the Ultima Activator II Reusable Drive Mechanism due to potential corrosion on pins, which could cause allergic reactions, metal toxicity, and other delayed health effects.

    Product
    Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0892-2022·2022-04-13

    Unauthorized SARS-CoV-2 Antigen Tests recalled for lack of FDA clearance

    WHPM Inc. is recalling approximately 535,755 First SIGN SARS-CoV-2 Antigen Tests distributed in California, Florida, Louisiana, Massachusetts, and Texas. The tests were sold without FDA Emergency Use Authorization or clearance.

    Product
    First SIGN SARS-CoV-2 Antigen Test
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0860-2022·2022-04-13

    GE Healthcare MRI Systems Recalled Due to Potentially Flipped Images

    GE Healthcare has recalled 653 SIGNA MRI systems worldwide due to a potential defect that could flip medical images left to right. This could affect diagnostic accuracy in patient care.

    Product
    1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0896-2022·2022-04-13

    C-Peptide ELISA Kit Recalled Due to Defective Standards

    DRG International recalls its C-Peptide ELISA kit (Catalog # EIA-1293) after the standards were found to have optical density below the required threshold. The defect may cause invalid test runs and delayed patient results.

    Product
    C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0893-2022·2022-04-13

    SPECT/CT Imaging Systems Recalled Due to Defective Balancing Weight Bolts

    Siemens is recalling seven Symbia Intevo SPECT/CT imaging systems due to a quality defect in the bolts that secure the CT balancing weights, which could create a safety issue.

    Product
    Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0890-2022·2022-04-13

    Customized Brius orthodontic devices recalled for design control failure

    Brius Technologies is recalling 13 customized metal orthodontic appliances that were sold and distributed prior to completing the required design control process and documentation.

    Product
    Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0879-2022·2022-04-13

    DeRoyal Ultra/Mammo Tray Medical Kits Recalled for Unvalidated Manufacturing Test Methods

    DeRoyal Industries is recalling 780 Ultra/Mammo Tray kits with antiseptic swabs due to uncertain validation of manufacturing test methods. Kits are used for patient skin preparation before surgery or injection.

    Product
    DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0895-2022·2022-04-13

    Abbott Amplatzer Steerable Delivery Sheath instructions for use updated

    Abbott is recalling 529 units of the Amplatzer Steerable Delivery Sheath (Class II) distributed outside the US due to an update to the device's instructions for use.

    Product
    Amplatzer Steerable Delivery Sheath
    Category
    Medical Device
    Distribution
    0 states