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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9451–9475 of 13748

  • 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-1483-2023·2023-05-17

    ANGIOGUARD RX / XP Emboli Capture Guidewire System separation during procedures

    The ANGIOGUARD RX / XP emboli capture guidewire system may separate from its delivery sheath during medical procedures, potentially leading to stroke or complications requiring emergency intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC
    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-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-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-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-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
    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-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-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-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-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-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-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-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-1473-2023·2023-05-10

    OttLite UVC Disinfecting Wand Emits Excessive Ultraviolet Radiation

    OttLite Rechargeable UVC Disinfecting Wand model UV10002M emits excessive ultraviolet radiation above safe limits. Approximately 7,376 units were distributed nationwide.

    Product
    OttLite Rechargeable UVC Disinfecting Wand
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1497-2023·2023-05-10

    CryoTreQ Aa ophthalmic instrument recalled for risk of sudden disassembly

    Beaver Visitec is recalling the CryoTreQ Aa ophthalmic surgical instrument due to risk of sudden disassembly during use. Device disassembly during cryosurgery could cause permanent vision impairment.

    Product
    CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue by extreme cold to locally perform cryocoagulation on tissu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1547-2023·2023-05-10

    Knee implant system recalled due to aseptic loosening and wear risk

    Linkbio Corp. is recalling the LINK SLED Knee System due to risk of early aseptic loosening and increased wear caused by improper surgical technique or positioning. The issue may require early revision surgery.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2230/07
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1499-2023·2023-05-10

    Walgreens assorted bandages recalled for undisclosed ingredient in adhesive

    ASO LLC is recalling Walgreens assorted bandages (item 196568) distributed nationwide due to benzalkonium chloride in the adhesive pad that is not disclosed on the labeling.

    Product
    WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack ASSORTED BANDAGES, 110 ASSORTED SIZES (retail package)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1514-2023·2023-05-10

    Knee implant recalled due to early aseptic loosening risk from surgical technique

    LINK SLED Knee System tibial components are being recalled due to risk of early aseptic loosening and increased wear from suboptimal implant positioning or inadequate cementing technique. Surgical technique guidance is being issued.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number: 15-2028/04
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1517-2023·2023-05-10

    LINK SLED Knee Implant Component Recalled Due to Loosening

    Linkbio Corp. recalls the LINK SLED Knee Component due to risk of early aseptic loosening and implant wear. The issue stems from suboptimal implant positioning or inadequate cementing technique.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1500-2023·2023-05-10

    GE Healthcare radiological imaging system patient information mismatch

    GE Healthcare's Centricity PACS-IW radiological imaging system can mismatch patient information when correcting study details. 17 units distributed worldwide are affected.

    Product
    Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e) 2066908-123, f) 2066908-136, g) 2066908-150; Radiological Image Processing System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1510-2023·2023-05-10

    LINK SLED knee implant system recalled for inadequate surgical technique

    Linkbio Corp. is amending training for the LINK SLED Knee System due to early implant loosening and wear caused by inadequate surgical positioning and cementing techniques. Healthcare providers should implement updated surgical guidance.

    Product
    LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1513-2023·2023-05-10

    Knee Implant System Component Recalled Due to Aseptic Loosening Risk

    Linkbio Corp. is recalling 13 units of the LINK SLED Knee System tibial component due to risk of aseptic loosening and increased wear. These risks arise from improper surgical positioning or inadequate cementing technique during implantation.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1519-2023·2023-05-10

    LINK SLED Knee System Tibial Component Recall Due to Early Loosening Risk

    Linkbio Corp. is recalling the LINK SLED Knee System ALL POLY TIBIAL COMPONENT due to risk of early aseptic loosening or increased wear from suboptimal surgical placement or cementing, which may require early revision surgery.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Item Number: 15-2028/09
    Category
    Medical Device
    Distribution
    2 states