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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4651–4675 of 27364

  • HighFDA (Devices)·Z-2753-2024·2024-09-04

    Medline Umbilical Line Kits Recalled Due to Syringe Quality Issues

    Medline is recalling Umbilical Line Kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and other quality issues.

    Product
    Medline procedural kits labeled as: UMBILICAL LINE KIT W/FOAM, Pack Number DYNDL1588A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2763-2024·2024-09-04

    Medline Recalls LEEP and Trab Buckle Kits Due to Syringe Defects

    Medline is recalling specific LEEP and Trab Buckle procedural kits because they contain plastic syringes with leaks or breakage risks.

    Product
    Medline procedural kits labeled as: 1) LEEP PACK, Pack Number DYNJ40348G; 2) TRAB BUCKLE DSC, Pack Number DYNJ63036B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2772-2024·2024-09-04

    Medline Centurion Procedure Kits Recalled for Syringe Quality Issues

    Medline is recalling Centurion procedure kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert regarding leaks and breakage.

    Product
    Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) BIOPSY KIT, Pack Number DYNDH1570; 5) BIOPSY TRAY-LF, Pack Number SPEC4380; 6) BMA BX
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2633-2024·2024-09-04

    Medline procedure packs recalled due to syringe quality issues

    Medline is recalling procedure packs containing Shenli syringes due to leaks, breakage, and other quality issues that may pose a risk to patient health.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: NEURO ANGIO PACK, Pack Number DYNDA1431A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2770-2024·2024-09-04

    Medical procedure kits recalled due to defective plastic syringes

    Medline's Centurion procedure kits are being recalled due to plastic syringes with leaks and breakage. The defective syringes may pose a risk to patient health during medical procedures.

    Product
    Centurion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC0255; 2) CT/ULTRASOUND BIOPSY, Pack Number SPEC0262; 3) FINE LACERATION KIT, Pack Number SUT17215; 4) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 5) LACERATION TRAY, Pack Number DYNDL1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2731-2024·2024-09-04

    Stryker iBur 3.0mm surgical burr recalled over thermal hazard

    Stryker Corporation is recalling the iBur 3.0mm Precision Match Head surgical burr because it may generate higher-than-specified temperatures during use, potentially causing thermal injury that may require medical intervention.

    Product
    Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2735-2024·2024-09-04

    Immunoassay analyzer software may delay test processing with automation systems

    A software issue in DxI 9000 Access analyzers connected to laboratory automation systems may prevent processing of all samples, flagging tests as timed out and potentially delaying patient results.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2636-2024·2024-08-28

    McGrath Mac Video Laryngoscope battery depletion may cause thermal event and explosion

    McGrath Mac Video Laryngoscope devices may experience battery management system failures causing batteries to deplete below design thresholds, potentially resulting in thermal events and explosions.

    Product
    McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2587-2024·2024-08-28

    ClotTriever XL Catheter instructions updated to prevent device entrapment and embolism

    Inari Medical has updated instructions for the ClotTriever XL Catheter (30 mm) to prevent device entrapment and pulmonary embolism. Approximately 2,488 units distributed worldwide are affected.

    Product
    ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2637-2024·2024-08-28

    McGRATH MAC EMS Video Laryngoscope Battery Management System Recall

    Covidien is recalling McGRATH MAC EMS Video Laryngoscopes due to a battery management system defect that may deplete below design specifications, creating risk of thermal events and explosion. About 10,449 units were distributed worldwide.

    Product
    McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2666-2024·2024-08-28

    Alcon ophthalmic surgical knives recalled for sharpness defect

    Alcon is recalling 145,248 ophthalmic knives (CLEARCUT SATINSLIT model 8065992745) due to increased complaint reports of inadequate sharpness. The surgical instruments were distributed nationwide and internationally.

    Product
    Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Catalog Number: 8065992745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2693-2024·2024-08-28

    IBA Proton Therapy System PROTEUS 235 Collision Detection Malfunction

    FDA recalls 19 units of the IBA Proton Therapy System PROTEUS 235 due to occasional failures in collision detection for the Forte Robotic Patient Positioning System affecting facilities across multiple US states and internationally.

    Product
    IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2673-2024·2024-08-28

    Alcon Ophthalmic Surgical Knives Recalled for Sharpness Defects

    Alcon recalls TOTAL PLUS ophthalmic surgical knives due to sharpness defect complaints. The 3,197 affected units are distributed nationwide and internationally.

    Product
    Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2646-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled by Alcon Due to Sharpness Defects

    Alcon is recalling 3,721 units of its 25GA Valved Entry System ophthalmic knives due to complaint reports about sharpness. The devices were distributed nationwide and internationally to 50+ countries.

    Product
    Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2689-2024·2024-08-28

    Disposable 5 Lead Cable System May Contain Non-Approved ECG Leads

    Stryker Sustainability Solutions is recalling disposable 5 lead cable systems that may contain non-approved ECG leads which were improperly reprocessed. The wrong components may cause devices to malfunction.

    Product
    Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2647-2024·2024-08-28

    Alcon ophthalmic surgical knives recalled for sharpness and performance degradation

    Alcon is recalling surgical instrument packs that include ClearCut and A-OK brand ophthalmic knives due to increasing complaints about sharpness loss. The affected knives could impact surgical precision during eye procedures.

    Product
    Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software Version: N/A Product Description: Standardized assemblage of components, which includes the valved trocar entry system, that interface with the CONSTELLATION Vision System. Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2672-2024·2024-08-28

    FDA Recalls Alcon Ophthalmic Knives for Decreased Blade Sharpness

    Alcon is recalling 1,061 ophthalmic surgical knives due to reports of decreased sharpness. The affected instruments are used in eye surgery procedures and may not perform as intended.

    Product
    Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2675-2024·2024-08-28

    Ophthalmic surgical knives recalled due to reported sharpness defects

    Alcon is recalling specific ophthalmic surgical knives due to reported sharpness defects. The recall affects 3,791 units distributed nationwide and internationally.

    Product
    Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2678-2024·2024-08-28

    Alcon ophthalmic surgical knives recalled for sharpness defects

    Alcon is recalling ClearCut and A-OK ophthalmic surgical knives due to sharpness complaints. The defect affects 1,057 units distributed nationwide and internationally.

    Product
    Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2680-2024·2024-08-28

    Alcon Ophthalmic Knives Recalled Due to Sharpness Defect Complaint Increase

    Alcon is recalling ClearCut and A-OK Corneal/Scleral ophthalmic knives due to increased complaints about sharpness. The recall affects 6,972 units distributed nationwide and internationally.

    Product
    Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2683-2024·2024-08-28

    FDA Recalls BioFire Pneumonia Diagnostic Test Kits for Control Failures

    BioFire Diagnostics recalls BIOFIRE FILMARRAY Pneumonia Panel plus test kits due to manufacturing defects that could lead to control failures and delayed test results. The affected kits were distributed in multiple US states and countries worldwide.

    Product
    BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2674-2024·2024-08-28

    Alcon ophthalmic surgical knives recalled for sharpness defects

    Alcon Research LLC recalls ClearCut and A-OK ophthalmic surgical knives due to increased reports of sharpness issues that may affect surgical performance.

    Product
    Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2661-2024·2024-08-28

    Alcon ophthalmic surgical knives recalled for sharpness defects

    Alcon is recalling ophthalmic surgical knives (model 8065990002) due to increased complaint reports regarding sharpness. Approximately 9,384 units have been distributed domestically and internationally.

    Product
    Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2650-2024·2024-08-28

    Ophthalmic Knives Recalled Due to Complaints About Reduced Sharpness

    Alcon is recalling ophthalmic knives for increased complaints of reduced sharpness. These surgical instruments require consistent blade sharpness for surgical precision in eye procedures.

    Product
    Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Model/Catalog Number: 8065772245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2649-2024·2024-08-28

    Alcon ClearCut S Ophthalmic Knives Recalled for Sharpness Complaints

    Alcon is recalling ClearCut S and A-OK ophthalmic surgical knives due to increased complaint reports about sharpness. Approximately 5,039 units were distributed nationwide and internationally.

    Product
    Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide