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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6576–6600 of 39968

  • ModerateFDA (Devices)·Z-2505-2024·2024-08-14

    Surgical Laser System Recalled Due to Wireless Footswitch Pairing Difficulties

    Olympus Corporation is recalling the Soltive Pro SuperPulsed Laser System due to difficulties pairing its wireless footswitch, which could delay surgical procedures. The recall affects 253 units worldwide.

    Product
    Soltive Pro SuperPulsed Laser System, Model TFL-SLS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2535-2024·2024-08-14

    NavaClick Syringe and Needle Model LIN02 Recalled for Incorrect Carton GTIN Label

    Lineage Biomedical is recalling NavaClick Syringe and Needle Model LIN02 due to an incorrect GTIN number on carton packaging. The recall affects 215 cartons distributed in Michigan and South Carolina.

    Product
    NavaClick Syringe and Needle, Model Number LIN02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2458-2024·2024-08-07

    BD Insyte Autoguard BC IV Catheter Recalled for Tubing Defect and Leakage

    Becton Dickinson has recalled certain BD Insyte Autoguard BC IV catheters due to potential holes in the catheter tubing that could cause leakage during insertion. The recall involves 26,400 units distributed in the United States.

    Product
    BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2416-2024·2024-08-07

    SlideView VS200 slide viewer laser shutter malfunction recall

    The SlideView VS200 slide viewer has a broken laser fuse caused by a short circuit from a poorly positioned cable. This prevents the shutter from operating properly, leaving it stuck in an open or closed position.

    Product
    SlideView VS200 slide viewer,
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2450-2024·2024-08-07

    Hip Replacement Prosthesis Recalled Due to Increased Postoperative Fracture Risk

    Zimmer hip replacement prostheses are recalled due to increased risk of postoperative femoral fracture. Affected devices are distributed nationwide; patients should consult their surgeon.

    Product
    CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 00811400230 00811400300 00811400310 00811400318 00811400330 00811400400 008114
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2451-2024·2024-08-07

    Capio SLIM Suture Capturing Device may fail to catch sutures consistently

    Boston Scientific is recalling some lots of Capio SLIM Suture Capturing Devices because they may not consistently catch sutures during surgery, potentially requiring prolonged procedures or additional medical intervention.

    Product
    Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2456-2024·2024-08-07

    Blood Culture Identification Panel May Produce False Positive Results

    The BIOFIRE BCID2 Panel may produce false positive Serratia marcescens results when used with certain culture media bottles, potentially leading to inappropriate changes in patient therapy.

    Product
    BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 410853
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2455-2024·2024-08-07

    Clinical Chemistry Analyzer Software Bugs May Cause Erroneous Patient Results

    Beckman Coulter's DxC 500 AU analyzer has two software bugs that may cause erroneous patient results due to misreported calibrations or expired reagents. No injuries or illnesses have been reported.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2452-2024·2024-08-07

    Boston Scientific Capio SLIM Device May Fail During Surgical Procedures

    Some lots of the Capio SLIM suture capturing device may fail to consistently catch sutures during surgery, potentially requiring extended procedures or additional medical intervention.

    Product
    Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2457-2024·2024-08-07

    Arctic Sun Temperature Management System software failure may disable critical safety alarms

    Arctic Sun Temperature Management Systems may fail to reach target temperature and critically fail to alert clinicians. The software defect affects approximately 10,507 units worldwide and risks hypothermia or hyperthermia.

    Product
    Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun Stat Japan/600020; Arctic Sun 5000, NA/5000-00-00; Arctic Sun 5000, NA w/ T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2453-2024·2024-08-07

    SOFT-VU KUMPE Diagnostic Catheter Recalled for Mislabeled Inner Pouch

    Angiodynamics recalls SOFT-VU KUMPE diagnostic catheters because inner pouch labels may show incorrect catheter length information, while the outer box label is accurate. 519 boxes distributed nationwide.

    Product
    SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2454-2024·2024-08-07

    SOFT-VU KUMPE Catheters Recalled for Mislabeled Inner Pouch

    Angiodynamics is recalling SOFT-VU KUMPE 5F X 65CM angiographic catheters (595 boxes nationwide) because inner pouch labels may show information for a different catheter model while shelf-box labels are correct.

    Product
    SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2409-2024·2024-07-31

    NIM Vital Nerve Monitoring Systems Recalled for False Negative Risk

    Medtronic Xomed is recalling NIM Vital Nerve Monitoring systems because they may fail to detect nerve damage or dysfunction. Approximately 7,804 units were distributed worldwide.

    Product
    NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2438-2024·2024-07-31

    Sensis Vibe diagnostic systems software crash during event documentation

    Siemens Sensis Vibe diagnostic systems may crash when using documentation features during once-per-study event reporting. Three systems are affected; no injuries reported.

    Product
    Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as wel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2024·2024-07-31

    BD Nano 2nd Gen Pen Needles recalled for post-expiration distribution

    Embecta Corp. is recalling BD Nano 2nd Gen Pen Needles that were distributed at or after their February 29, 2024 expiration date. Using expired needles cannot guarantee sterility and integrity.

    Product
    BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral administration of a drug from a cartridge contained in a drug pen injector Model/C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2414-2024·2024-07-31

    Dxl 9000 Immunoassay Analyzer Recalled for Corrosion of USB Cable Contacts

    Beckman Coulter is recalling 143 Dxl 9000 Immunoassay Analyzers due to nonconforming USB cables with brass instead of gold contacts. Brass may corrode, potentially disabling internal communication and delaying patient test results.

    Product
    Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2430-2024·2024-07-31

    Abbott Infinity 5 Pulse Generator May Fail Prematurely

    Abbott is recalling 5,900 Infinity 5 implantable pulse generators because the replacement indicator and end-of-service date may be shorter than labeled, potentially causing premature device failure. Patients should contact their doctor about device status.

    Product
    Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2432-2024·2024-07-31

    Abbott Infinity 7 Implantable Pulse Generators Recalled for Potentially Shortened Service Life

    Abbott is recalling 1198 Infinity 7 Implantable Pulse Generators due to potentially incorrect service life indicators and end-of-service dates in product labeling, which could result in loss of therapy.

    Product
    Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2431-2024·2024-07-31

    Abbott Infinity 7 Pulse Generator May Have Shorter-Than-Labeled Service Date

    The Abbott Infinity 7 implantable pulse generator's replacement indicator and end-of-service date may be shorter than the product labeling states, potentially leading to loss of therapy for patients.

    Product
    Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2441-2024·2024-07-31

    Sensis Vibe medical diagnostic system software crashes during documentation events

    A software issue in certain Siemens Sensis Vibe diagnostic systems may cause the application to crash when documentation features are used during clinical reporting events.

    Product
    Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2423-2024·2024-07-31

    Medtronic TourniKwik Tourniquet Set Recalled for Incorrect Component

    Medtronic is recalling 636 units of TourniKwik Tourniquet Sets due to incorrect components placed in four manufactured lots. Distribution includes the US states of Minnesota, Massachusetts, Utah, California, Florida, Japan, and Slovenia.

    Product
    TourniKwik Tourniquet Set (CFN 79012)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2435-2024·2024-07-31

    Perfusor Space syringe pump recalled for Cardinal Health syringe incompatibility

    B Braun is recalling Perfusor Space syringe pumps because manufacturing changes to Cardinal Health Monoject syringes may cause incompatibility, resulting in dosing errors or delayed treatment.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor¿ Space Syringe Pump, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2436-2024·2024-07-31

    Perfusor Space infusion pump syringe incompatibility may cause dosing error

    B Braun is recalling Perfusor Space infusion pump kits because Cardinal Health Monoject syringes have manufacturing changes that make them incompatible, potentially causing overdose, underdose, or delayed therapy.

    Product
    Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, Infusion Pump Kit, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2433-2024·2024-07-31

    Infusion Pump Syringe Compatibility Issue May Cause Overdose or Underdose

    B Braun is recalling Perfusor Space infusion pumps due to syringe compatibility issues with Cardinal Health Monoject syringes. The incompatibility may cause overdose, underdose, therapy delays, and alarm failures.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product Description: Perfusor Space Infusion Pump System, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2418-2024·2024-07-31

    Wireless Nurse Call Station Recalled for Potential Alarm Communication Failure

    Arial Call Station wireless nurse call systems (models CSK200-1069 and CSK200-1069MR) are recalled due to risk of alarm communication failure and premature battery depletion. 77 units affected across multiple U.S. states.

    Product
    Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.
    Category
    Medical Device
    Distribution
    13 states