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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5301–5325 of 13512

  • 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-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-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-2745-2024·2024-09-04

    Medline recalls three medical procedure kits with defective plastic syringes

    Medline is recalling three procedural kits containing plastic syringes with leaks and breakage issues that may pose a risk to patient health. The kits have been distributed worldwide.

    Product
    Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516; 2) PICC INSERTION TRAY W/O CATH, Pack Number PICCNC0004; 3) VASCATH INSERTION PACK, Pack Number, CVI4825
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2830-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Defective Sol-M Syringes Recalled

    Beaver Visitec International recalls BVI CustomEyes Procedure Packs containing defective Sol-M syringes. About 1,756 units were distributed nationwide due to manufacturing defects.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000867;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2727-2024·2024-09-04

    Stryker iBur surgical burs recalled due to overheating risk

    Stryker Corporation recalls iBur 3.0mm surgical burs used in neurosurgery, spinal, and ENT procedures due to potential overheating at the bur-shank interface. The heat risk may cause tissue damage requiring medical intervention.

    Product
    Stryker iBur 3.0mm 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-2741-2024·2024-09-04

    Medline preop nerve block trays recalled for syringe quality defects

    Medline is recalling Preop Nerve Block Tray kits worldwide due to plastic syringes with leaks, breakage, and quality defects. These defects were identified in an FDA safety alert and may pose risks to patient health.

    Product
    Medline procedural kits labeled as: PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040H
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2780-2024·2024-09-04

    Centurion Procedure Packs with Defective Syringes Recalled Worldwide

    MEDLINE INDUSTRIES is recalling Centurion procedure packs containing syringes with documented leaks, breakage, and other quality defects. The affected syringes may pose a risk to patient health during medical procedures.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST BIOPSY KIT, Pack Number DYNDH1512A; 2) CIRCUMCISION KIT, Pack Number CIT6535; 3) CIRCUMCISION KIT, Pack Number CIT7095; 4) CIRCUMCISION TRAY, Pack Number CIT6860A; 5) CIRCUMCISION TRAY, Pack N
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2760-2024·2024-09-04

    Medline procedural kits recalled for syringe leaks and breakage

    Medline procedural kits contain plastic syringes with leaks and breakage that may pose health risks. The affected kits are used for delivery procedures and distributed worldwide.

    Product
    Medline procedural kits labeled as: 1) INFANT DELIVERY KIT , Pack Number DYKM1426; 2) SR OB DELIVERY , Pack Number DYNJ908583; 3) SR OB DELIVERY , Pack Number DYNJ908583A; 4) VAG DELIVERY, Pack Number DYNJ909097
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2750-2024·2024-09-04

    Medline Procedural Kits with Defective Plastic Syringes Recalled

    Medline procedural kits contain plastic syringes affected by an FDA Safety Alert. The syringes may leak or break, posing risks to patients during medical procedures.

    Product
    Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number DYNJ902703K; 3) ENT TYMPANOPLASTY PACK-LF , Pack Number DYNJ38988J; 4)FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179A; 5) FREE FLAP TRAM ADD ON PACK, Pa
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2635-2024·2024-09-04

    Medline Medical Convenience Kits with Plastic Syringe Defects

    Medline is recalling approximately 1.68 million medical convenience kits with plastic syringes affected by leaks and breakage. The defects may pose a risk to patient health per an FDA Safety Alert issued March 19, 2024.

    Product
    Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 2) DR DIULUS INJECTION PACK, Pack Number DYNDA2391; 3) BLOCK KIT , Pack Number DYNDA2508; 4) NERVE BLOCK PAIN PACK, Pack Number DYNDL1389; 5) BLOCK TRAY-LF , Pack Number DYNJ0117039; 6) NER
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2779-2024·2024-09-04

    Centurion Procedure Packs With Defective Syringes Recalled Worldwide

    Medline Industries is recalling Centurion procedure packs containing plastic syringes with identified leaks, breakage, and quality defects. The recall affects units distributed worldwide.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) CIRCUMCISION TRAY, Pack Number CIT6720; 3) CIRCUMCISION TRAY, Pack Number CIT6720A
    Category
    Medical Device
    Distribution
    0 states
  • 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-2886-2024·2024-09-04

    BVI CustomEyes Procedure Packs containing Sol-M Syringes Recalled Nationwide

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M-manufactured syringes. The recall affects 138 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001579;
    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-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-2744-2024·2024-09-04

    Medline Circumcision Kits Recalled Due to Defective Syringes

    Medline is recalling two circumcision tray kit models due to plastic syringes with leaks, breakage, and quality defects that may harm patients. The kits have been distributed worldwide.

    Product
    Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920
    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-2733-2024·2024-09-04

    GE Healthcare Proteus XR/a X-Ray System Missing De-Installation Manual

    GE Healthcare's Proteus XR/a stationary X-ray system lacks a required de-installation manual, creating risk of personnel injury during device removal.

    Product
    GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-2631-2024·2024-09-04

    Medline procedure packs with syringes recalled due to leaks and breakage

    Medline Industries recalled procedure packs containing Shenli syringes due to leaks, breakage, and quality defects. The recalled units were distributed worldwide and may pose a risk to patient health.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2625-2024·2024-09-04

    Medical Convenience Kits with Defective Plastic Syringes Recalled

    Medline Industries recalls medical convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose risks to patient health. About 1.6 million units were distributed worldwide.

    Product
    See RES Description
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2764-2024·2024-09-04

    Medline procedural kits recalled for plastic syringe defects

    Medline is recalling procedural kits containing plastic syringes with leaks, breakage, and other quality defects. These defects may pose a risk to patient safety.

    Product
    Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2) ASC CATARACT PACK , Pack Number DYNJ0855117O ; 3) BAI , Pack Number DYNJ53847D ; 4) BASIC EYE PACK, Pack Number DYNJ83699A ; 5) BASIC EYE PACK, Pack Number DYNJ81805; 6) BASIC EYE PACK, Pa
    Category
    Medical Device
    Distribution
    0 states