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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13451–13475 of 13802

  • ModerateFDA (Devices)·Z-2059-2021·2021-07-21

    GE Healthcare MRI system button error causes incorrect diagnostic images

    GE Healthcare's SIGNA MR355 and MR360 MRI systems are recalled due to a button UI issue that may cause diagnostic images to be flipped or incorrectly annotated. No patient harm has been reported.

    Product
    SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2067-2021·2021-07-21

    Medical device recall: Lingen SAMPLE Virus Sampling Kit lacks FDA clearance

    Mercedes Medical voluntarily recalled Lingen SAMPLE Virus Sampling Kits due to lack of FDA 510(k) clearance. The recall affects units distributed nationwide and internationally.

    Product
    Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2066-2021·2021-07-21

    Medical Device Recall: Lingen Disposable Virus Sampling Kit, No 510(k) Clearance

    The Lingen Disposable Virus Sampling Kit by Mercedes Medical was voluntarily recalled due to lacking FDA 510(k) clearance. The recall affected approximately 11,711 boxes distributed nationwide and internationally.

    Product
    Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2051-2021·2021-07-21

    Medical device recall: EASYGRIP FLO-41 barcode expiration date discrepancy

    Baxter Healthcare Corporation is recalling 4,752 units of EASYGRIP FLO-41 hemostatic delivery devices due to a discrepancy between the expiration date encoded in the 2D barcode and the human-readable date on the product.

    Product
    EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
    Category
    Medical Device
    Distribution
    0 states
  • 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
    47 states
  • 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-2010-2021·2021-07-14

    Luminex Verigene C. difficile Test Kit Recalled for False-Negative Results

    Luminex Corporation is recalling 1,261 Verigene Clostridium difficile test kits due to potential for false-negative results. The kits may fail to detect C. difficile infections, potentially delaying diagnosis.

    Product
    Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2006-2021·2021-07-14

    Luminex Verigene Respiratory Pathogens Test Recalled for False-Negative Risk

    Luminex Corporation is recalling 38,990 Verigene Respiratory Pathogens Flex nucleic acid tests due to potential false-negative results. The tests were distributed worldwide, including throughout the United States.

    Product
    Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
    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-2037-2021·2021-07-14

    Sterile Femoral Angiography Drape Recall Due to Sticking Plastic Film

    Cardinal Health is recalling sterile femoral angiography drapes because the plastic film causes drapes to stick, which may prevent proper unfolding and application during procedures.

    Product
    Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - 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-2033-2021·2021-07-14

    Sterile Angiography Drapes Recalled Due to Sticking Plastic Film Defect

    Cardinal Health is recalling 3,192 units of Sterile Radial/Femoral Angiography Drapes due to sticking plastic film that may prevent proper unfolding and application during surgical procedures.

    Product
    Sterile Radial/Femoral Angiography Drape, Catalog Number 29529 - 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-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-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-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-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-2011-2021·2021-07-14

    Verigene Gram Negative Blood Culture Test Recalled for Risk of False-Negative Results

    Luminex Corporation is recalling 165 units of the Verigene BC-GNv2 diagnostic test worldwide due to the potential for false-negative results in blood culture testing.

    Product
    Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2041-2021·2021-07-14

    Medtronic CoreValve Evolut R Delivery Catheter System Recalled for Actuator Separation

    Medtronic is recalling CoreValve Evolut R Delivery Catheter Systems due to reports of actuator separation. The affected devices, manufactured before July 11, 2020, were distributed globally.

    Product
    CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;
    Category
    Medical Device
    Distribution
    47 states
  • 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-2029-2021·2021-07-14

    ARTIS Angiography System Software Error Causes C-Arm Positioning Deviation

    A software error in ARTIS angiography systems can cause the C-arm to deviate from intended position by up to 22 cm during imaging procedures. Affected units require identification by serial number.

    Product
    ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2026-2021·2021-07-14

    Siemens Atellica Analyzer Valves Recalled for Manufacturing Defect Risk

    Siemens Healthcare Diagnostics has recalled Atellica CH 930 Analyzer valves that may malfunction due to a manufacturing defect. The affected valves may wear and leak over time, potentially impacting diagnostic test accuracy.

    Product
    Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
    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-2014-2021·2021-07-14

    ADVIA Chemistry XPT System Software May Report Incorrect Patient Test Results

    Siemens Healthcare is recalling certain ADVIA Chemistry XPT systems with software version 1.4 or lower due to a default mixer failure detection setting that may allow incorrect patient lab results to be reported without alerting clinicians.

    Product
    The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for in
    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