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.

Filters

Agency

Category

Minimum severity

Clear filters

10201–10225 of 40095

  • SevereFDA (Devices)·Z-1485-2023·2023-05-17

    ANGIOGUARD RX/XP Guidewire System May Separate During Medical Procedures

    The ANGIOGUARD RX/XP Emboli Capture Guidewire System may separate during medical procedures, potentially delaying treatment or requiring unplanned intervention. The recall affects 471 units distributed worldwide.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1490-2023·2023-05-17

    ANGIOGUARD RX/XP Emboli Capture Guidewire System May Separate During Procedures

    ANGIOGUARD RX/XP emboli capture guidewire systems may separate from their delivery sheaths during interventional procedures, potentially causing stroke. Cordis is recalling 56 units distributed worldwide.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1493-2023·2023-05-17

    ANGIOGUARD Emboli Capture Guidewire System recalled due to potential device separation

    Cordis US Corp's ANGIOGUARD RX/XP Emboli Capture Guidewire System is being recalled by the FDA (Class I) because the delivery system and capture sheath may separate during medical procedures, potentially requiring emergency intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1428-2023·2023-05-17

    Cook Blue Rhino G2 Tracheostomy Introducer Trays Recalled for Connection Defect

    Cook Incorporated is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Trays because the device connectors are not making secure connections with 15mm caps and other circuit components, resulting in unsecure connections.

    Product
    Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721), C-PTISY-100-HC-G-NA-FLEX8.5 (G57717), C-PTISY-100-HC-G-NA-FLEX7.5 (G57716)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1495-2023·2023-05-17

    Emboli Capture Guidewire System Separation Risk Recalls ANGIOGUARD RX/XP

    Cordis US Corp is recalling ANGIOGUARD RX/XP Emboli Capture Guidewire Systems worldwide due to potential separation of the delivery system and capture sheath during procedures, which could cause stroke or require emergency intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1491-2023·2023-05-17

    Emboli Capture Guidewire System recalled due to potential device separation

    Cordis US Corp is recalling the ANGIOGUARD RX/XP Emboli Capture Guidewire System (1,087 units worldwide) due to potential separation of the delivery system and capture sheath, which could lead to stroke.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1488-2023·2023-05-17

    FDA Class I Guidewire System Recalled for Device Separation Risk

    Cordis US Corp is recalling the ANGIOGUARD RX / XP Emboli Capture Guidewire System because the device may separate during procedures, risking stroke or requiring emergency intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1486-2023·2023-05-17

    Emboli Capture Guidewire System Recalled Due to Potential Component Separation

    Cordis US Corp recalls 54 units of the ANGIOGUARD RX/XP Emboli Capture Guidewire System due to potential separation of device components. This could delay procedures or result in unplanned intervention, including possible stroke.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1492-2023·2023-05-17

    ANGIOGUARD Emboli Capture Guidewire System Recalled Due to Device Separation

    The FDA has recalled the ANGIOGUARD RX/XP Emboli Capture Guidewire System because the delivery system and capture sheath could separate during use, potentially causing stroke or requiring emergency surgery.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1489-2023·2023-05-17

    Emboli Capture Guidewire System recalls risk of device separation during procedures

    Cordis is recalling an emboli capture guidewire system due to potential separation of components during medical procedures. The separation could cause procedural delays, unplanned interventions, or stroke.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1487-2023·2023-05-17

    Emboli Capture Guidewire System Separation Hazard Prompts FDA Recall

    The ANGIOGUARD RX/XP Emboli Capture Guidewire System may separate from its delivery sheath during medical procedures, potentially causing stroke or requiring emergency surgery. Cordis US Corp is recalling 146 units worldwide.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1569-2023·2023-05-17

    Aesculap Caiman Articulating Surgical Device Recalled for Loose Spring

    Aesculap Caiman Articulating electrosurgical devices are being recalled because a spring may become loose and fall out during surgery, potentially entering the patient's body.

    Product
    Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery. Product Code: PL771SU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1574-2023·2023-05-17

    Medtronic Spinal Distractor Rack Recalled for Manufacturing Defect

    Medtronic is recalling Distractor Rack devices used in spinal surgery due to manufacturing defects that may prevent proper device operation. Two lot numbers are affected and were distributed to facilities in Indiana, Connecticut, and Nebraska.

    Product
    Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1578-2023·2023-05-17

    Sheath Introducer Kit with Incorrect Needle Size Recalled

    Merit Medical Systems is recalling COBRA-OS Sheath Introducer Kits due to an incorrect needle size that may affect proper insertion during medical procedures.

    Product
    COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1564-2023·2023-05-17

    Bard Mission Biopsy Instrument Kit cannula and needle incompatibility

    Bard Mission Disposable Biopsy Instrument Kit has an incompatibility defect where the cannula is oversized relative to the needle, preventing proper insertion and tissue access. This could cause procedure delays and insufficient tissue collection.

    Product
    Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1577-2023·2023-05-17

    STA Compact Max analyzer firmware bug causes inaccurate test results

    A firmware bug in Diagnostica Stago's STA Compact Max analyzer causes intermittent shortened coagulation times and frequent technical errors that produce inaccurate lab test results. Five units were distributed to clinical laboratories nationwide.

    Product
    STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1572-2023·2023-05-17

    APLS IgM Diagnostic Reagent Packs Recalled Due to Incorrect Conjugate

    Bio-Rad Laboratories is recalling 932 BioPlex 2200 APLS IgM Reagent Packs (Lot 301538) nationwide because they were packaged with incorrect conjugate. This could result in false-positive and false-negative test results.

    Product
    BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1573-2023·2023-05-17

    Laboratory Management Software May Display Incorrect Slide Labels

    TDHisto/Cyto laboratory management software may display incorrect information on slide labels in specific use cases. The FDA has issued a Class II recall affecting laboratories nationwide in California.

    Product
    TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1571-2023·2023-05-17

    PDS Plus Antibacterial Suture Potential Breakage During Intraoperative Use

    Ethicon recalled 1,656 units of PDS Plus Antibacterial Suture due to potential breakage during surgery, which could compromise tissue approximation. The affected lot was distributed to the United Kingdom, Ireland, and Turkey.

    Product
    PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1575-2023·2023-05-17

    STA R Max Analyzer Firmware Bug Produces Inaccurate Coagulation Test Results

    Diagnostica Stago is recalling the STA R Max fully automatic clinical analyzer due to a firmware bug that causes intermittent shortened coagulation times and increased technical errors, potentially producing inaccurate blood clotting test results.

    Product
    STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2023·2023-05-17

    BD Pyxis MedStation ES software failure causes patient data loss

    BD Pyxis automated dispensing cabinet software versions 1.7.0 through 1.7.4 experience download failures causing partial loss of patient information and transaction data. This may result in dispensing incorrect medication doses, allergenic medications, or discontinued medications.

    Product
    BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1484-2023·2023-05-17

    ANGIOGUARD RX/XP Emboli Capture Guidewire System Separation Risk

    Cordis has recalled 684 units of ANGIOGUARD RX/XP Emboli Capture Guidewire System due to potential separation of the delivery system and capture sheath during use, which could cause stroke or require unplanned surgical intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1576-2023·2023-05-17

    STA Compact Analyzer Firmware Bug Causes Inaccurate Test Results

    Diagnostica Stago is recalling STA Compact Analyzers due to a firmware bug causing intermittent shortened coagulation times and increased technical errors. No illnesses or injuries have been reported.

    Product
    STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1570-2023·2023-05-17

    M-Close Kit suturing apparatus recalled due to plastic housing fracture risk

    New Wave Endo-Surgical is recalling the M-Close Kit surgical suturing apparatus because the plastic housing may fracture. The recall affects 295 units distributed in Florida, Massachusetts, and Georgia.

    Product
    M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1477-2023·2023-05-10

    Philips ProxiDiagnost N90 radiography systems recalled due to cable damage

    Philips is recalling certain ProxiDiagnost N90 radiography systems due to a cable under the table that may break. A broken cable could prevent users from tilting the table or engaging braking.

    Product
    Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system
    Category
    Medical Device
    Distribution
    Distributed nationwide