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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13476–13500 of 13802

  • HighFDA (Devices)·Z-2039-2021·2021-07-14

    FilmArray Pneumonia Panel Kits Recalled Due to Shelf-Life False Negatives

    BioFire Diagnostics is recalling FilmArray Pneumonia Panel test kits globally due to stability failures that increase false negative results between 6 and 12 months of shelf life.

    Product
    FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-2009-2021·2021-07-14

    Verigene Enteric Pathogens Test May Return False-Negative Results

    Luminex Corporation is recalling Verigene Enteric Pathogens diagnostic tests due to potential for false-negative results, which could miss serious bacterial infections.

    Product
    Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2035-2021·2021-07-14

    Cesarean Birth Drapes Recalled Due to Sticking Plastic Film

    Cardinal Health is recalling 1,638 units of Sterile Cesarean Birth Drapes due to defective plastic film that prevents proper unfolding and application during surgery.

    Product
    Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2027-2021·2021-07-14

    Atellica IM 1300 Analyzer Valves Recalled Due to Manufacturing Defect

    Siemens is recalling Atellica IM 1300 diagnostic analyzer valves due to a manufacturing defect that may cause leaking and affect test result accuracy.

    Product
    Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2038-2021·2021-07-14

    Angiography and Cesarean Birth Drapes recalled due to sticking defect

    Cardinal Health is recalling Nonsterile Femoral Angiography and Cesarean Birth Drapes (15,360 units) because plastic film causes sticking that may prevent proper unfolding and application.

    Product
    Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2032-2021·2021-07-14

    Nonsterile Femoral Angiography Drapes Recalled Due to Sticking Plastic Film Defect

    Cardinal Health is recalling 26,250 units of Nonsterile Femoral Angiography Drapes due to a manufacturing defect causing the drapes to stick and preventing proper application. This may compromise surgical site protection.

    Product
    Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2034-2021·2021-07-14

    Nonsterile Radial/Femoral Angiography Drapes Recalled for Sticking Defect

    Cardinal Health is recalling 13,426 units of Nonsterile Radial/Femoral Angiography Drape (Catalog #29529N) due to a manufacturing defect where plastic film causes the drapes to stick, preventing proper unfolding and application in surgical settings.

    Product
    Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1992-2021·2021-07-14

    HydraVision Fluoroscopy System Displays Inaccurate Radiation Dose Measurements

    LIEBEL-FLARSHEIM is recalling HydraVision Digital Imaging Systems because the displayed radiation doses are higher than actual delivered doses, potentially affecting clinical decision-making and radiation safety.

    Product
    HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2003-2021·2021-07-14

    VISIONIST CRT-P Pacemaker Recalled Due to Battery Depletion Risk

    Boston Scientific has recalled 5,920 VISIONIST CRT-P pacemakers due to hydrogen gas buildup that can compromise a capacitor and cause accelerated battery depletion. Affected patients should contact their healthcare provider for device evaluation.

    Product
    VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2036-2021·2021-07-14

    Cesarean Birth Drapes recalled due to defective plastic film causing sticking

    Cardinal Health is recalling Cesarean Birth Drapes due to a plastic film defect. The defect causes the drapes to stick, preventing proper unfolding and application during surgery.

    Product
    Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1998-2021·2021-07-14

    Essentio Pacemaker Models Recalled for Potential Battery Depletion Risk

    Boston Scientific is recalling six Essentio pacemaker models due to a hydrogen release defect that may compromise a critical capacitor and cause accelerated battery depletion. Approximately 31,548 units worldwide are affected.

    Product
    Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2042-2021·2021-07-14

    Medtronic CoreValve Evolut PRO Delivery Catheter Actuator Separation Recall

    Medtronic is recalling 67,339 CoreValve Evolut PRO Delivery Catheter Systems manufactured before July 11, 2020, due to reports of actuator separation that could affect device function.

    Product
    CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-2012-2021·2021-07-14

    ACE Control Set stability claim failure requires updated handling instructions

    Sentinel CH SpA is recalling ACE Control Set diagnostic control kits due to stability claims after reconstitution that do not meet specified requirements. Updated handling instructions have been provided to affected users.

    Product
    ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2021-2021·2021-07-14

    GE Revolution CT User Interface Issue with Scan Groups

    The GE Revolution CT user interface may fail to confirm when scan group names are added if they contain characters other than letters, numbers, or spaces.

    Product
    The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs inclu
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2022-2021·2021-07-14

    GE Healthcare Revolution CT user interface fails to confirm scan group addition

    The GE Healthcare Revolution CT system's user interface fails to update and confirm when scan group names are added using certain characters. This configuration defect requires a software fix to ensure proper scan group setup.

    Product
    The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs includ
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2031-2021·2021-07-14

    Sterile Femoral Angiography Drape Sticks; Cannot Unfold Properly

    Cardinal Health is recalling 574 units of Sterile Femoral Angiography Drapes because the plastic film causes the drapes to stick, preventing proper unfolding and application during surgery.

    Product
    Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2023-2021·2021-07-14

    GE Revolution CT scanner user interface fails to confirm scan group names

    The GE Revolution CT imaging system's user interface fails to update and confirm when scan group names contain characters other than letters, numbers, or spaces, potentially causing user uncertainty during scan setup.

    Product
    The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either witho
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1953-2021·2021-07-07

    Blood Lead Test Kit Recalled for Inaccurate Control Test Results

    Magellan Diagnostics recalls LeadCare Plus Blood Lead Test Kit after control tests generated low results, potentially underestimating patient blood lead levels. Affected lot numbers include 2011MU, 2104MU, and 2108MU.

    Product
    LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1952-2021·2021-07-07

    LeadCare II Blood Lead Test Kit Control Test Inaccuracy Recall

    The LeadCare II Blood Lead Test Kit may generate artificially low control test results, causing blood lead levels to be underestimated in patient samples. Kits were distributed worldwide.

    Product
    LeadCare II Blood Lead Test Kit Catalog Number 70-6762
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1954-2021·2021-07-07

    LeadCare Ultra Blood Lead Test Kit Recalled for Control Test Inaccuracy

    Magellan Diagnostics is recalling the LeadCare Ultra Blood Lead Test Kit due to control test failures causing potential underestimation of blood lead levels in patient samples. The recall involves 441 kits with worldwide distribution.

    Product
    LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1989-2021·2021-07-07

    Philips Medical Monitor Bracket May Detach from Ceiling Mount

    Philips medical imaging monitors with worn bracket assembly shafts may detach from ceiling suspensions and fall on patients, operators, or staff. No injuries have been reported.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1977-2021·2021-07-07

    Exactech Humeral Augmented Tray orthopedic implant components recalled for disengagement risk

    Exactech is recalling Humeral Augmented Tray (HAT) orthopedic implant components because the retaining ring may disengage during use. The recall affects 36 devices distributed in six U.S. states.

    Product
    Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1955-2021·2021-07-07

    Synaptive Suction Sets Recalled for Metal Burrs on Tube Interior

    Synaptive Medical is recalling 1,291 Trackable Suction Sets for visible metal burrs and filings along the inner suction tube. The defect may contaminate the surgical field or cause injury.

    Product
    Synaptive Trackable Suction Set Standard and Malleable
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1994-2021·2021-07-07

    Bard PowerPICC Catheter Kits Recalled for Wrong Guidewire Size

    Bard Access Systems is recalling PowerPICC catheter convenience kits with incorrect guidewires. Kits labeled as containing 70 cm guidewires actually contain 50 cm guidewires, which could affect proper catheter placement.

    Product
    5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire
    Category
    Medical Device
    Distribution
    Distributed nationwide