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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6476–6500 of 13512

  • HighFDA (Devices)·Z-1720-2024·2024-05-08

    Zimmer Distal Lateral Fibular Plate Recall: Locking Screw Malfunction Risk

    Zimmer orthopedic plates may have thread defects preventing locking screws from properly securing to the implant. This could delay surgery or cause loss of fixation requiring additional intervention.

    Product
    ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1746-2024·2024-05-08

    RayStation Radiation Therapy Planning Software Recalled for Calculation Error

    RayStation radiation therapy planning software versions 10.0.0.1154, 10.0.1.52, and 10.0.2.10 have been recalled due to a potential calculation parameter issue that could affect treatment planning. The FDA classified this as a Class II recall affecting 213 units worldwide.

    Product
    RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1722-2024·2024-05-08

    Zimmer surgical fracture plates may fail to lock properly

    Zimmer periarticular locking plates used in orthopedic surgery have a thread defect that may prevent proper locking of screws. The defect could delay surgery or result in loss of fixation requiring additional intervention.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1708-2024·2024-05-08

    Zirconium oxide dental blocks recalled for cracking risk

    IVOCLAR VIVADENT is recalling 2,472 units of IPS e.max ZirCAD CER/in. Prime dental material blocks because defects may cause cracks during sintering, risking fracture in the patient's mouth.

    Product
    IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1691-2024·2024-05-08

    Intellis AdaptiveStim Spinal Cord Stimulator unable to reprogram

    Medtronic Neuromodulation recalls the Intellis AdaptiveStim spinal cord stimulator because one device cannot be reprogrammed. Patients should consult their healthcare provider.

    Product
    Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1705-2024·2024-05-08

    Zirconium oxide dental blocks recalled due to cracking and fracture risk

    IVOCLAR VIVADENT is recalling IPS e.max ZirCAD zirconium oxide blocks nationwide because they may develop cracks after sintering that could cause dental restorations to fracture in patients' mouths.

    Product
    IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1752-2024·2024-05-08

    RayStation radiation therapy system dosing parameter recall

    RayStation 15.0.0.430 radiation therapy planning system may have an elevated SSD parameter. Users should contact Raysearch Laboratories AB for corrective guidance.

    Product
    RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1740-2024·2024-05-08

    Stryker Distal Access Catheter recalled for out-of-specification endotoxin contamination

    Stryker Neurovascular is recalling 43 units of Distal Access Catheter Lot 0000486382 due to out-of-specification endotoxin results. The affected lot was distributed across 12 states.

    Product
    The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1723-2024·2024-05-08

    ZPLP Distal Lateral Fibular Plates: locking screws may not secure

    Zimmer is recalling ZPLP Distal Lateral Fibular Plates due to a threading defect in the locking holes that may prevent screws from properly securing. The defect could result in loss of surgical fixation.

    Product
    ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1715-2024·2024-05-08

    Zimmer Distal Lateral Fibular Plate may fail to lock properly

    Zimmer orthopedic plates may have thread defects preventing locking screws from properly mating, potentially resulting in loss of fixation and need for additional surgery.

    Product
    ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 7-2357-018-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1704-2024·2024-05-08

    Zirconium oxide dental blocks recalled due to cracking risk

    IVOCLAR VIVADENT AG is recalling 7,445 units of IPS e.max ZirCAD CER/in. Prime zirconium oxide blocks because they may crack during sintering, potentially causing dental restorations to fracture in patients' mouths.

    Product
    IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1718-2024·2024-05-08

    Zimmer Periarticular Locking Plate System recalled due to faulty screw threads

    Zimmer recalls Periarticular Locking Plate System devices due to thread defects that may prevent proper screw locking and cause surgical delay or loss of fixation.

    Product
    ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1710-2024·2024-05-08

    Zimmer Periarticular Locking Plates Recalled for Potential Loss of Surgical Fixation

    Zimmer recalled certain Periarticular Locking Plates due to a thread form defect that may prevent locking screws from properly seating. The defect may result in loss of fixation or delayed surgery requiring additional intervention.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1748-2024·2024-05-08

    Radiation Therapy Planning System May Calculate Skin Surface Distance Incorrectly

    RayStation radiation therapy planning software versions 11.0.0.951, 11.0.1.29, 11.0.3.116, and 11.0.4.15 may calculate skin surface distance (SSD) values incorrectly, potentially affecting dose calculations. Affected software has been distributed worldwide.

    Product
    RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1709-2024·2024-05-08

    Zimmer Distal Lateral Fibular Plate may fail to lock screws securely

    Zimmer's Distal Lateral Fibular Plate has threading defects that may prevent screws from locking properly. The defect could go unnoticed during surgery and cause loss of fixation.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1734-2024·2024-05-08

    Galaxy System Wired Controller Recalled for Unintended Scope Motion

    Noah Medical recalls 17 Galaxy System wired controllers (Model GAL-019) due to calibration misalignment that may cause unintended scope motion during bronchoscopic procedures.

    Product
    Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1713-2024·2024-05-08

    Zimmer Periarticular Locking Plate screw-mating defect risks surgical fixation loss

    Zimmer's Periarticular Locking Plate System has a thread defect that may prevent proper screw locking, potentially causing loss of surgical fixation. Affected units distributed worldwide.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1612-2024·2024-05-01

    Route 92 Medical 070 Access System Recalled for Distal Tip Separation Risk

    Route 92 Medical 070 Access System catheters are recalled for potential distal tip separation during neurovasculature procedures. The defect affects 117 units distributed across 30 US states and New Zealand.

    Product
    Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
    Category
    Medical Device
    Distribution
    30 states
  • SevereFDA (Devices)·Z-1610-2024·2024-05-01

    Route 92 Medical Access System Recalled for Distal Tip Separation

    Route 92 Medical's Full Length 070 Access System (REF 7002) is recalled due to potential distal tip separation at the proximal marker band of the delivery catheters. This FDA Class I recall affects a device used in neurovasculature interventions distributed across the US and New Zealand.

    Product
    Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
    Category
    Medical Device
    Distribution
    30 states
  • SevereFDA (Devices)·Z-1611-2024·2024-05-01

    Route 92 Medical Reperfusion System Potential Catheter Tip Separation

    Route 92 Medical recalls its Full Length 070 Reperfusion System due to potential distal tip separation at the proximal marker band, which could affect device delivery during interventional procedures.

    Product
    Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
    Category
    Medical Device
    Distribution
    30 states
  • SevereFDA (Devices)·Z-1464-2024·2024-05-01

    VITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk

    Biomerieux Inc is recalling VITEK 2 AST test kits due to ceftriaxone concentration errors that could produce false susceptible results in antimicrobial susceptibility testing.

    Product
    VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491;
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1613-2024·2024-05-01

    Route 92 Medical delivery catheter recalled due to tip separation risk

    Route 92 Medical is recalling Tenzing 7 delivery catheters because the distal tip may separate from the proximal marker band. The affected units were distributed across the US and New Zealand.

    Product
    Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
    Category
    Medical Device
    Distribution
    30 states
  • SevereFDA (Devices)·Z-1614-2024·2024-05-01

    Route 92 Medical Reperfusion System Recalled for Potential Device Separation

    Nineteen units of the Route 92 Medical 070 Reperfusion System may experience distal tip separation. Healthcare facilities should cease use of affected devices immediately.

    Product
    Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.
    Category
    Medical Device
    Distribution
    30 states