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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4576–4600 of 27364

  • HighFDA (Devices)·Z-2736-2024·2024-09-04

    Lab analyzer incorrectly configured for complex testing at waived facilities

    Five Afinion 2 lab analyzers were distributed with incorrect configuration, potentially allowing waived laboratories to perform moderately complex assays that could produce erroneous results.

    Product
    Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2728-2024·2024-09-04

    Stryker iBur Surgical Bur Recall Due to Excessive Heat Risk

    Stryker is recalling iBur 4.0mm Coarse Diamond surgical burs that may overheat during use. Excessive heat could cause tissue or bone damage requiring medical intervention.

    Product
    Stryker iBur 4.0mm Coarse Diamond Round, 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-2610-2024·2024-09-04

    Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Flange Defect

    Smiths Medical is recalling specific lots of Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2829-2024·2024-09-04

    Voluntary Recall of BVI CustomEyes Procedure Packs With Sol-M Syringes

    BVI CustomEyes Procedure Packs containing Sol-M manufactured low dead space and Luer Slip syringes are subject to a voluntary recall. Approximately 142 units were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000866;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2720-2024·2024-09-04

    Medical Device: Ion Endoluminal System Recalled for Instrument Arm Screw Failure

    Intuitive Surgical is recalling the Ion Endoluminal System due to potential screw failure in the instrument cart arm, which could cause uncontrolled catheter motion in patient airways.

    Product
    Ion Endoluminal System, REF: 380748-65
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2798-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled for Defective Sol-M Syringes

    Beaver Visitec International voluntarily recalled BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The recall affects 69 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000162;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2898-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M syringes recalled

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The recall affects 123 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001649;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2941-2024·2024-09-04

    FRT250 Telescopic Implant Cartridge Recalled for Component Substitution

    OrthoPediatrics Canada is recalling FRT250 cartridges used in the Fassier-Duval Telescopic IM System because an incorrect component was substituted during assembly.

    Product
    FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2629-2024·2024-09-04

    Medline Procedure Packs with Defective Syringes Recalled Worldwide

    Medline recalls approximately 1.7 million procedure packs containing defective Shenli syringes due to leaks and breakage that may pose patient risks. The syringes are affected by an FDA Safety Alert from March 2024.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2797-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled for Sol-M Syringe Components

    Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The recall affects 351 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000126;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2623-2024·2024-09-04

    Medline procedure packs with syringes recalled due to leaks and breakage

    Medline is recalling procedure packs containing Shenli syringes due to leaks, breakage, and quality issues that may pose risks to patient health. Over 1.6 million units have been distributed worldwide.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2) FTMC LOCAL PACK-LF, pack number DYNJ54607A, 3) LOCAL PACK, pack number DYNJ61839B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2628-2024·2024-09-04

    Medical Convenience Kits with Plastic Syringes Recalled Due to Quality Defects

    Medline Industries is recalling medical convenience kits containing plastic syringes due to quality issues including leaks and breakage that may pose a risk to patient health. The recall affects 1,679,067 units distributed worldwide.

    Product
    See RES description
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2729-2024·2024-09-04

    Stryker iBur surgical bur recalled for potential overheating at junction

    Stryker has recalled 1171 units of iBur 5.0mm surgical burs due to potential overheating at the bur shank junction. The overheating could cause thermal injury requiring medical intervention.

    Product
    Stryker iBur 5.0mm Coarse Diamond Round, 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)/ Otorhinolaryngol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2739-2024·2024-09-04

    Medline pediatric anesthesia circuit kits with defective plastic syringes

    Medline procedural kits contain plastic syringes with leaks, breakage, and quality issues that may pose patient health risks. Affected units have been distributed worldwide.

    Product
    Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F; 2) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327G
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2754-2024·2024-09-04

    Medline Procedural Kits with Defective Syringes Recalled Worldwide

    Medline procedural kits with defective plastic syringes are recalled due to risks of leaks and breakage. The affected syringes were flagged in an FDA safety alert and may compromise patient safety during medical procedures.

    Product
    Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2593-2024·2024-09-04

    Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Flange Defect

    Smiths Medical is recalling specific lots of Bivona tracheostomy tubes because the securement flange may tear due to a manufacturing defect.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2722-2024·2024-09-04

    Stryker iBur Surgical Bur Recalled Due to Excessive Temperature Risk

    Stryker recalls iBur 3.0mm Precision Round surgical burs due to potential for excessive temperatures where the bur shank meets the bushing. Thermal injury risk may require medical intervention.

    Product
    Stryker iBur 3.0mm Precision Round, 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)/ Otorhinolaryngology; an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2749-2024·2024-09-04

    Medline Circumcision Tray Kits Recalled for Defective Syringes

    Medline procedural kits containing circumcision trays are being recalled due to plastic syringes affected by an FDA Safety Alert. The syringes have identified leaks and breakage that may pose risks to patient health.

    Product
    Medline procedural kits labeled as: CIRCUMCISION TRAY, Pack Number DYNDA2271
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2748-2024·2024-09-04

    Medline Fetal Surgery Kits Recalled Due to Defective Plastic Syringes

    Medline Industries is recalling procedural kits containing plastic syringes that may leak or break. The syringes were identified in a March 2024 FDA Safety Alert and may pose a risk to patient health.

    Product
    Medline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS840214Q; 2) FETAL SURGERY CDS-LF, Pack Number CMPJ26754O
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2758-2024·2024-09-04

    Medline Medical Procedural Kits Recalled for Defective Plastic Syringes

    Multiple Medline procedural kits contain defective plastic syringes that may leak or break during medical procedures. The FDA has advised of potential patient health risks from these manufacturing quality issues.

    Product
    Medline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 2) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 3) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 4) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 5) STERI
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2734-2024·2024-09-04

    Electrocardiograph Recall: CARDIOVIT AT-180 May Produce Signal Artifacts

    Schiller is recalling CARDIOVIT AT-180 electrocardiographs due to potential high-frequency signal artifacts during ECG acquisition that may affect diagnostic accuracy. 1,084 units are affected worldwide.

    Product
    CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2839-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Recall

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain Sol-Millennium Medical syringes that are subject to a manufacturer recall. A total of 103 units were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001025;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2766-2024·2024-09-04

    Centurion procedure kits recalled due to defective plastic syringes

    Medline Industries is recalling Centurion procedure kits containing plastic syringes with leaks and breakage issues. The defective syringes may pose a risk to patient health during medical procedures.

    Product
    Centurion procedure kits labeled as: 1) BIOPSY KIT, Pack Number DYNDA1466A; 2) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 5) PERITONSILLAR ABSCESS TRAY, Pack Number MN
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2792-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Subject to Voluntary Recall

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes distributed nationwide. The recall affects 35 units with Part Number 584770 and is classified as FDA Class II.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584770;
    Category
    Medical Device
    Distribution
    Distributed nationwide