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.

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11976–12000 of 13802

  • ModerateFDA (Devices)·Z-0917-2022·2022-04-20

    FDA Recalls Touch Screen Modules for IVUS Imaging Systems

    Volcano Corp is recalling MM-TSM touch screen modules used with IntraSight Integrated IVUS systems because they may crack or become damaged, potentially rendering the imaging equipment non-functional.

    Product
    MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-0933-2022·2022-04-20

    Medical Device Linearity Standards Recalled Due to Improper Storage Controls

    Medline Industries is recalling Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards due to improper storage controls that may affect test result timing. The recall affects 10 boxes distributed to healthcare facilities in six states.

    Product
    Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0901-2022·2022-04-20

    IntraSight Mobile IVUS touch screen modules missing required labeling information

    IntraSight Mobile IVUS Systems touch screen modules lack required labeling information including device identifier and manufacturer information. Affected units were distributed to healthcare facilities in the US and internationally.

    Product
    IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0884-2022·2022-04-13

    Alinity m HBV AMP Kit Recalled for Risk of Falsely High Test Results

    Abbott Molecular is recalling the Alinity m HBV AMP Kit due to potential for falsely high results on negative samples. The kits are used for Hepatitis B virus testing in the US and internationally.

    Product
    Alinity m HBV AMP Kit (US and CE)
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0864-2022·2022-04-13

    Total Knee Surgical Kit Recall Due to Potential Sterility Breach

    Stradis Medical is recalling 76 units of Total Knee Surgical Kits with potentially perforated or torn outer bags that may compromise sterility. Distribution occurred in Indiana, Texas, and Pennsylvania.

    Product
    Total Knee Pack - Surgical Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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-0882-2022·2022-04-13

    Philips infant/child defibrillator pads recalled for gel separation defect

    Philips is recalling 331,712 infant and child defibrillator pads worldwide due to potential gel separation from the pad backing. The gel may fold onto itself or separate nearly completely, leaving reduced surface coverage on the pad.

    Product
    Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only FOR USE WITH HEARSTART DEFIBRILLATORS
    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-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-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-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-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-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-0859-2022·2022-04-13

    GE SIGNA Excite 3T MRI Systems Recalled Over Potential Image Flip

    GE Healthcare is recalling 55 SIGNA Excite 3T MRI systems due to potential for images to be flipped left to right, which could affect diagnostic accuracy. The affected systems were distributed worldwide.

    Product
    SIGNA Excite 3T. Magnetic Resonance Imaging System
    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-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-0858-2022·2022-04-13

    GE Healthcare MRI Systems May Display Flipped Images Affecting Diagnosis

    GE Healthcare's 1.5T and 3.0T SIGNA Excite HD MRI systems may display medical images flipped left to right, potentially affecting diagnostic accuracy. The recall involves 76 units distributed worldwide.

    Product
    1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0867-2022·2022-04-13

    X-ray fluoroscopy system may deliver excessive radiation dose

    Shimadzu FLUOROspeed X1 fluoroscopy systems may deliver radiation doses exceeding federal regulatory limits in specific fluoroscopic operating modes due to inadequate installation adjustment criteria.

    Product
    MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0869-2022·2022-04-13

    X-ray System Radiation Dose May Exceed Safety Limits in Some Modes

    Shimadzu SonialVision safire X-ray systems may emit radiation exceeding federal limits during some fluoroscopic procedures. The manufacturer is addressing installation criteria to prevent potential dose violations.

    Product
    MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
    Category
    Medical Device
    Distribution
    37 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-0866-2022·2022-04-13

    Surgical kit recall due to outer bag perforation and sterility risk

    Stradis Medical is recalling 348 units of its Total Joint Pack Surgical Kit due to risk of outer bag tears or perforations that could compromise kit sterility. The recall affects units distributed in Indiana, Texas, and Pennsylvania.

    Product
    Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide