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 the agency’s own highest classification or reported deaths or serious injuries, 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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14176–14200 of 39988

  • HighFDA (Devices)·Z-2013-2021·2021-07-14

    Randox RX Imola Analyzer Software Freeze Recall - 50 Units Affected

    Randox recalls 50 RX Imola Analyser units nationwide and in Puerto Rico due to software freezing that prevents test results from displaying.

    Product
    Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2021·2021-07-14

    CoreValve Evolut PRO PLUS Delivery Catheter Systems recalled for actuator separation

    Medtronic is recalling CoreValve Evolut PRO PLUS Delivery Catheter Systems due to reports of actuator separation that could affect proper deployment of these cardiac devices.

    Product
    CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-2024-2021·2021-07-14

    Vivorte Bone Void Filler Recalled for Incorrect Expiration Date

    Vivorte, Inc. is recalling Trabexus EB bone filler due to an incorrect expiration date on product labels. The label shows expiration of 02-15-2019, but the actual expiration is 12-18-2018.

    Product
    Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2002-2021·2021-07-14

    VALITUDE CRT-P Pacemaker Recalled Due to Potential Accelerated Battery Depletion

    Boston Scientific VALITUDE CRT-P pacemakers (models U125 and U128) may experience hydrogen release that compromises the capacitor, causing accelerated battery depletion. Patients should consult their healthcare provider.

    Product
    VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2001-2021·2021-07-14

    Altrua 2 Pacemakers at Risk from Hydrogen-Induced Battery Failure

    Boston Scientific is recalling 2,952 Altrua 2 pacemaker units (models S701, S702, S722) distributed worldwide due to hydrogen release that can damage the capacitor and accelerate battery depletion.

    Product
    Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
    Category
    Medical Device
    Distribution
    0 states
  • 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-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
    48 states
  • 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-2000-2021·2021-07-14

    Accolade Pacemakers Recalled for Hydrogen-Related Battery Depletion

    Boston Scientific is recalling Accolade pacemaker models L300, L301, L310, L311, L321, and L331 due to latent hydrogen release that compromises the capacitor and accelerates battery depletion.

    Product
    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
    Category
    Medical Device
    Distribution
    0 states
  • 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
  • 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…
    Category
    Medical Device
    Distribution
    0 states
  • 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…
    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…
    Category
    Medical Device
    Distribution
    0 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
  • 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-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-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-1993-2021·2021-07-07

    Percutaneous Dilation Tracheostomy Kit Recalled for Incorrect Size Labeling

    One lot of PORTEX ULTRperc Percutaneous Dilation Tracheostomy Kit (Lot 4072715) was incorrectly labeled as 7.0mm when it is 9.0mm. The 40 units were distributed in Pennsylvania, Michigan, Maryland, and Florida.

    Product
    PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1982-2021·2021-07-07

    Monitor Bracket Assembly Fall Hazard Recall Affects Multiple CT Systems

    Philips is recalling 1,301 monitor bracket assemblies used with CT systems due to shaft wear that could cause monitors to fall, potentially injuring patients, operators, bystanders, or service personnel.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 64, Brilliance 40, Ingenuity Flex 728235 - Brilliance 40 728231/728232 - Brilliance 64 728317/728318 - Ingenuity Flex
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1987-2021·2021-07-07

    Philips CT Monitor Bracket May Detach Due to Shaft Wear

    Philips CT fluoroscopy monitors may develop bracket shaft wear that could lead to the monitor detaching and falling while attached to cables.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT
    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-1975-2021·2021-07-07

    PERLA TL Lateral Connector Open Spinal Fusion Devices Recalled for External Label Error

    SPINEART SA is recalling 44 units of PERLA TL Lateral Connector Open spinal fusion connectors distributed in the U.S. due to external labels that incorrectly list the rod size.

    Product
    PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Models: PERLA TL Lateral Connector Open, 15mm PERLA TL Lateral Connector Open, 30mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1979-2021·2021-07-07

    Philips CT Monitor Bracket Assembly risks ceiling fall hazard

    Philips is recalling 1,301 Monitor Bracket Assemblies used in CT and PET/CT imaging systems worldwide due to potential shaft wear that could cause the monitor to detach from the ceiling mount and fall, posing injury risk.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model - MX8000 Models: 728120/728125/728201
    Category
    Medical Device
    Distribution
    Distributed nationwide