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

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

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13051–13075 of 27471

  • HighFDA (Devices)·Z-2974-2020·2020-09-23

    Inpeco FlexLab 3.6 Automation Recalled for Potential Sample ID Mis-association

    Inpeco S.A. is recalling 8 FlexLab 3.6 Automation systems because firmware issues may cause sample ID mis-association, leading to incorrect or delayed clinical chemistry results.

    Product
    Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2954-2020·2020-09-23

    Integra Padgett Dermatome Set Recalled Due to Cable Melting

    Integra LifeSciences is recalling 13 dermatome sets because the handpiece cable melts after sterilization, posing a risk to patients and staff.

    Product
    Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2960-2020·2020-09-23

    Terumo Ultrasonic Air Sensor Recall Due to Backwards Crimped Wire

    Terumo is recalling three Ultrasonic Air Sensors because a crimped wire was installed backwards, potentially causing false air bubble alarms during extracorporeal procedures.

    Product
    Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2956-2020·2020-09-23

    Novarad Recalls NovaPACS Diagnostic Viewer Software Due to Image Placement Error

    Novarad Corporation is recalling NovaPACS Diagnostic Viewer software because the cross-localization feature may inaccurately place reference lines on asymmetrical images.

    Product
    NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, CR/DX, NM, PT, and XA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2978-2020·2020-09-23

    Life Technologies Recalls TaqPath RT-PCR COVID-19 Kit Software

    Life Technologies is recalling the TaqPath RT-PCR COVID-19 Kit due to software issues that may cause invalid, inconclusive, or false test results.

    Product
    The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2961-2020·2020-09-23

    Terumo Ultrasonic Air Sensor Recalled for Intermittent Connection Defect

    Terumo is recalling two Ultrasonic Air Sensors because a manufacturing defect may cause intermittent connections and false air bubble alarms during extracorporeal procedures.

    Product
    Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2979-2020·2020-09-23

    Life Technologies Recalls TaqPath RT-PCR COVID-19 Kit Software

    Life Technologies is recalling the TaqPath RT-PCR COVID-19 Kit due to software issues that may cause invalid, inconclusive, or false test results.

    Product
    The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the QuantStudio Real-Time PCR platforms), includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2972-2020·2020-09-23

    Imactis Patient Fiducial Recalled Due to Component Separation Risk

    Imactis is recalling Patient Fiducial components because they may separate from the body, potentially causing navigation inaccuracies or improper needle trajectory.

    Product
    Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2966-2020·2020-09-23

    Randox Ammonia Reagent Recall Due to Positive Bias in Patient Samples

    Randox Laboratories is recalling 143 kits of the AM1054 Ammonia reagent because it shows a positive bias of up to 140 µmol/l on patient samples.

    Product
    AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2952-2020·2020-09-23

    Longhorn PrimeStore Molecular Transport Medium Tubes Recalled for Cyanide Risk

    Longhorn Vaccines and Diagnostic is recalling PrimeStore Molecular Transport Medium tubes because the solution may produce cyanide gas when exposed to bleach.

    Product
    PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2955-2020·2020-09-23

    Integra Padgett Electric Dermatome Set Recalled Due to Cable Melting

    Integra LifeSciences is recalling 2 units of the Padgett Electric Dermatome Set because the handpiece cable melts after sterilization.

    Product
    Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2909-2020·2020-09-16

    CareFusion Alaris System PC Unit Model 8015 Recalled for Keypad Defect

    CareFusion is recalling Alaris System PC Unit Model 8015 infusion pumps because fluid ingress can cause unresponsive or stuck keypad keys, potentially delaying or interrupting medication infusions.

    Product
    Alaris System PC Unit Model 8015
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-2910-2020·2020-09-16

    CareFusion PC Unit Front Case with Keypad Replacement Kits Recalled

    CareFusion 303, Inc. is recalling PC Unit Front Case with Keypad Replacement Kits because fluid ingress may cause keys to become unresponsive or stuck, potentially delaying or interrupting life-sustaining infusions.

    Product
    PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2, TC10013702 ASSY, CASE, FRONT W/KEYPAD, 8015LS, TC10013664 ASSY FR CASE W/ KEYPAD 8015 M2
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-2939-2020·2020-09-16

    CareFusion Recalls BD Alaris Infusion Pumps Due to Keypad Defects

    CareFusion is recalling BD Alaris infusion pumps because fluid ingress can cause unresponsive or stuck keys, potentially delaying or interrupting infusions.

    Product
    BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
    Category
    Medical Device
    Distribution
    54 states
  • HighFDA (Devices)·Z-2938-2020·2020-09-16

    Qiagen SARS-CoV-2 Test Panel Recalled for Influenza A False Positives

    Qiagen is recalling 1,474 QIAstat-Dx Respiratory SARS-CoV-2 Panel kits due to an increased rate of false positive results for Influenza A, which may lead to inappropriate antiviral use or delayed diagnosis.

    Product
    QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2950-2020·2020-09-16

    Intuitive Surgical Recalls ION Reprocessing Accessories Kit Due to Catheter Failure Risk

    Intuitive Surgical is recalling 27 units of the ION Reprocessing Accessories Kit because the catheter reprocessing cover may disengage, causing chemical retention and system failure.

    Product
    ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2949-2020·2020-09-16

    Intuitive Surgical Recalls Ion Catheter Reprocessing Covers

    Intuitive Surgical is recalling 67 Ion Catheter Reprocessing Covers because they may fail to engage correctly, potentially causing catheter or system failure.

    Product
    Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2882-2020·2020-09-16

    CareFusion Recalls BD Alaris Modules for Incorrect Syringe Display

    CareFusion 303, Inc. is recalling BD Alaris Syringe and PCA Modules because they may display incorrect syringe types or sizes, potentially causing infusion errors.

    Product
    BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652
    Category
    Medical Device
    Distribution
    54 states
  • HighFDA (Devices)·Z-2946-2020·2020-09-16

    Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Incorrect Size Labeling

    Smiths Medical ASD Inc. is recalling three Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tubes because the labels display the incorrect size. The units were distributed in Connecticut.

    Product
    Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2927-2020·2020-09-09

    Siemens Dimension Vista Troponin I Reagent Cartridge Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling Dimension Vista High Sensitivity Troponin I reagent cartridges because they may exhibit a negative bias with patient samples.

    Product
    Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number K6427, SMN# 104471067
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2925-2020·2020-09-09

    Brainlab Cirq Arm System Recalled for Reduced Holding Force

    Brainlab AG is recalling 21 Cirq Arm Systems because prolonged non-use can reduce the holding force of the positioning arm.

    Product
    Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2921-2020·2020-09-09

    Siemens Sensis Vibe Hemo System Recalled for Connector Defect

    Siemens is recalling 110 Sensis Vibe Hemo systems because a connector may break, potentially causing the device to stop functioning and lose vital signs.

    Product
    Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2919-2020·2020-09-09

    Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects

    Cardinal Health is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes and tears at the cuffs.

    Product
    PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for…
    Category
    Medical Device
    Distribution
    Distributed nationwide