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 13717

  • 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-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-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-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-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-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-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-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-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-1552-2023·2023-05-10

    Knee Implant Recall for Aseptic Loosening and Implant Wear Risk

    The LINK SLED Knee System is recalled due to risk of early aseptic loosening and implant wear caused by suboptimal surgical positioning or inadequate cementing. The manufacturer is updating surgical guidance and providing additional training.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1532-2023·2023-05-10

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

    Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early aseptic loosening and increased wear from improper implant positioning or inadequate cementing. Patients may require revision surgery earlier than expected.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1505-2023·2023-05-10

    Siemens ADVIA Centaur Cortisol Diagnostic Kits Recalled for Negative Measurement Bias

    Siemens Healthcare Diagnostics is recalling 18,961 ADVIA Centaur Cortisol diagnostic kits due to negative bias in urine samples causing intermittently low test results that could affect clinical diagnosis.

    Product
    ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Number 10994927). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and li
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1542-2023·2023-05-10

    Knee Implant System Recalled for Risk of Aseptic Loosening

    Linkbio Corp. recalls the LINK SLED Knee System due to risk of aseptic loosening from improper positioning or cementing technique, potentially requiring revision surgery. Five units affected in US and international distribution.

    Product
    LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1516-2023·2023-05-10

    LINK SLED Knee System tibial component subject to surgical technique amendment

    A knee implant component is being recalled due to risks of early loosening or increased wear caused by suboptimal implant positioning or inadequate cementing. Manufacturers are providing updated surgical guidance.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1531-2023·2023-05-10

    LINK SLED Knee Implant Recall Due to Loosening and Wear Risks

    Linkbio Corp. is recalling 14 units of LINK SLED Knee System implants due to risk of early aseptic loosening or wear from suboptimal positioning or inadequate cementing. Updated surgical technique training is being issued.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1504-2023·2023-05-10

    Siemens Atellica cortisol kits recalled for negative bias in urine testing

    Siemens Healthcare Diagnostics recalls 34,746 Atellica IM Cortisol diagnostic kits due to negative bias in urine test results, which may produce inaccurately low cortisol measurements.

    Product
    Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1544-2023·2023-05-10

    Knee Implant Component Recalled for Surgical Positioning and Cementing Guidance

    FDA is updating surgical instructions for the LINK SLED Knee System to address early aseptic loosening and increased wear from suboptimal positioning or inadequate cementing technique. Updated training aims to prevent implant failure and unexpected revision surgery.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1563-2023·2023-05-10

    Laboratory automation system firmware recalled for sample mis-identification

    Inpeco is recalling Alinity h laboratory automation system firmware that may mis-identify samples, causing incorrect electrolyte test results that could lead to improper patient treatment.

    Product
    Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1503-2023·2023-05-10

    FDA Class II Recall: Ultraview SL Command Module Monitoring Alarms May Fail

    Spacelabs Healthcare is recalling 1,088 Ultraview SL Command Module units due to a software defect. The devices may fail to display alarms or waveforms when parameter processing is suspended, potentially causing clinicians to miss critical patient events.

    Product
    Ultraview SL (UVSL) Command Module, Model 91496
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1548-2023·2023-05-10

    LINK SLED knee implant system surgical technique amendment for aseptic loosening prevention

    Linkbio Corp. is updating surgical technique guidance for the LINK SLED knee implant system to prevent early aseptic loosening or implant wear caused by suboptimal positioning or cementing technique during surgery.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1515-2023·2023-05-10

    LINK SLED Knee Implant Tibial Component: Surgical Technique Amendment

    Linkbio Corp. is issuing updated surgical technique guidance and training for the LINK SLED Knee System tibial component due to risk of early implant loosening or wear from suboptimal positioning or inadequate cementing.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number: 15-2028/05
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1476-2023·2023-05-10

    Steris Light Handle Covers May Detach During Surgical Use

    Steris Corporation is recalling 263,280 surgical light handle covers worldwide because they may separate from the light handle during procedures, potentially compromising the sterile field.

    Product
    Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment. REF: LB44
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1540-2023·2023-05-10

    LINK SLED Knee System recalls issued over aseptic loosening risk

    Linkbio Corp. is recalling LINK SLED Knee System knee components due to risk of early aseptic loosening or increased wear. The company is issuing updated surgical technique guidance to address suboptimal implant positioning and cementing techniques.

    Product
    LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1525-2023·2023-05-10

    LINK SLED Knee Implant Component Recall for Aseptic Loosening Risk

    Linkbio Corp. is recalling the LINK SLED Knee System's all-poly tibial component due to risk of early aseptic loosening and increased wear from suboptimal implant positioning or inadequate cementing during surgery.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15
    Category
    Medical Device
    Distribution
    2 states