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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13426–13450 of 27500

  • HighFDA (Devices)·Z-2444-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of Sterile Disposable Connectors because internal tests identified potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert Label:050432000 / 00803622123184
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2472-2020·2020-07-08

    United Imaging uCT 530 CT System Recalled for Scanning Interruptions

    Shanghai United Imaging Healthcare is recalling four uCT 530 Computed Tomography X-Ray Systems in Texas due to software issues that may cause scanning interruptions or image artifacts.

    Product
    uCT 530 Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2409-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component may fail, causing the device to stop working or fail to start.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2454-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 744 units of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2467-2020·2020-07-08

    Radiometer ABL80-FLEX Box Label Recall for Barcode Misinterpretation Risk

    Radiometer Medical ApS is recalling ABL80-FLEX box labels because barcode misinterpretation on analyzers may cause patient mix-ups or delayed treatment.

    Product
    ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2446-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of Sterile Disposable Connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2475-2020·2020-07-08

    Mueller Hybrid Wraparound Knee Support Recalled for Latex Mislabeling

    Mueller Sports Medicine is recalling Hybrid Wraparound Knee Supports because they contain natural rubber despite being labeled as latex-free.

    Product
    Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2441-2020·2020-07-08

    Mediana Attendant Vital Signs Monitor Recalled for Temperature Measurement Failures

    Mediana Co., Ltd. is recalling 180 Attendant Vital Signs Monitors because failures were found in the temperature measurement function while in predict mode.

    Product
    DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2464-2020·2020-07-08

    LivaNova Recalls Vein Irrigation Cannulas Due to Sterile Barrier Breach

    LivaNova is recalling 325 Vein Irrigation Cannulas because internal tests found potential breaches in the sterile barrier, which could compromise sterility.

    Product
    Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2406-2020·2020-07-01

    Mevion Proton Radiation Treatment System Recalled for Software Error

    Mevion Medical Systems is recalling eight MEVION S250i and S250 Proton Radiation Treatment Systems because a software error can cause couch correction moves to be partially lost.

    Product
    MEVION S250i, MEVION S250; Proton Radiation Treatment System
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2404-2020·2020-07-01

    Siemens Atellica IM1300 Analyzer Recall for Insufficient Sample Detection Failure

    Siemens is recalling 927 Atellica Solution IM1300 Analyzers because they may fail to detect insufficient samples when using specific sample cups.

    Product
    Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2429-2020·2020-07-01

    Suntech Oscar 2 Blood Pressure Monitor Recall for Display Error

    Suntech Medical is recalling Oscar 2 blood pressure monitors because the display may show an incorrect decimal point for three-digit readings in mmHg.

    Product
    Oscar 2, Model 250 System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2425-2020·2020-07-01

    Zest Anchors Recalls Locator Overdenture Implant Systems Due to Abutment Defects

    Zest Anchors LLC is recalling Locator Overdenture Implant Systems because the abutments may be out of specification, potentially causing a gap between the implant and abutment.

    Product
    LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2418-2020·2020-07-01

    Hocoma Lokomat Pro Recalled for Uncontrolled Body Weight Support Rope Movement

    Hocoma AG is recalling 494 Lokomat Pro units because a motor controller failure may cause the body weight support rope to move up or down in an uncontrolled way.

    Product
    Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120V PE; 30683 LokomatPro L6.2 110V FD PE; 30684 LokomatPro L6.2 110V FD Kombi; 32001 LokomatPro L6.2 110V FD AD Product Usage: The intended use of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2423-2020·2020-07-01

    Tosoh AIA-900 Analyzer Recalled for Substrate Monitoring Defect

    Tosoh Bioscience Inc is recalling 529 AIA-900 Analyzers because the substrate monitoring system may fail to detect empty bottles, leading to erroneous immunoassay test results.

    Product
    AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2403-2020·2020-07-01

    Merge Healthcare Software Recall for Inaccurate Z-Score Calculations

    Merge Healthcare is recalling specific versions of Merge Cardio software due to a calculation error that may produce false negative Z-Scores.

    Product
    Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2020·2020-07-01

    GE Healthcare Recalls CARESCAPE Patient Data Modules Due to False Alarms

    GE Healthcare is recalling CARESCAPE Patient Data Modules because they may display false flat-line ECGs and asystole alarms when used with an AED.

    Product
    CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042084-001 2094504-001 2042084-001-046050 2042084-001-208621 2042084-001-045915 2042084-001-215164 2042084-001-078474…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2405-2020·2020-07-01

    Siemens Atellica Solution IM1600 Analyzer Recall for Sample Detection Issues

    Siemens is recalling Atellica Solution IM1600 Analyzers because insufficient sample volumes may not be detected when using specific sample cups.

    Product
    Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2428-2020·2020-07-01

    Providence Medical Technologies Recalls Ally Bone Screws Due to Dimensional Error

    Providence Medical Technologies is recalling 208 units of Ally Bone Screws due to a potential dimensional manufacturing error that poses a safety risk to patients.

    Product
    Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only. L Providence Medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2235-2020·2020-06-24

    GE Healthcare Recalls Giraffe OmniBed Incubators Due to Oxygen Display Error

    GE Healthcare is recalling Giraffe OmniBed infant incubators equipped with Servo Oxygen modules because they may deliver a different oxygen level than displayed.

    Product
    Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2393-2020·2020-06-24

    Defibtech Recalls 860 Lifeline PRO AEDs Due to Shock Delivery Failure

    Defibtech is recalling 860 Lifeline PRO AEDs because a component issue may cause the device to abort or fail to deliver a shock.

    Product
    DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2236-2020·2020-06-24

    GE Healthcare Recalls Giraffe Incubators with Servo Oxygen Module

    GE Healthcare is recalling Giraffe Incubators with Servo Oxygen modules because they may deliver different oxygen levels than displayed.

    Product
    Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2390-2020·2020-06-24

    Medtronic Bone Void Filler Recalled for Potential Setting Defects

    Medtronic is recalling 36 units of Bone Void Filler, Small, because the product may not maintain its setting characteristics for the labeled shelf-life, potentially increasing surgical time.

    Product
    Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2388-2020·2020-06-24

    Siemens MAMMOMAT Revelation Mammography System Recalled for Biopsy Removal Limitation

    Siemens is recalling MAMMOMAT Revelation mammography systems because a software limitation may make it difficult to remove the vacuum biopsy system if an exam is interrupted.

    Product
    MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2382-2020·2020-06-24

    Stryker Locking Screw Recall Due to Potential Sterility Compromise

    Stryker is recalling specific lots of Locking Screws because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide