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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5276–5300 of 13512

  • 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
  • HighFDA (Devices)·Z-2773-2024·2024-09-04

    Medical convenience kits with syringes recalled due to quality issues

    Medline Industries is recalling Centurion procedure packs containing plastic syringes affected by an FDA Safety Alert from March 19, 2024. The syringes may have leaks, breakage, or other quality issues that could pose a health risk.

    Product
    Centurion procedure packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC4380; 2) CIRCUMCISION TRAY, Pack Number CIT6325; 3) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 4) LUMBAR PUNCTURE TRAY, Pack Number PT215; 5) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2747-2024·2024-09-04

    Medline Procedural Kits Recalled Due to Defective Plastic Syringes

    Medline is recalling multiple procedural kits containing plastic syringes that may leak, break, or have quality defects. These defects may pose a risk to patient health during surgical procedures.

    Product
    Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016T; 3) MAJOR EAR PACK, Pack Number CMPJ01846O; 4) EAR PACK, Pack Number CMPJ05884J; 5) MZ EAR PACK , Pack Number CMPJ09860D; 6) KIT MAJOR EAR CHRG, Pack
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2752-2024·2024-09-04

    Medline surgical procedure kits recalled due to defective plastic syringes

    Medline is recalling surgical procedure kits containing plastic syringes that may leak or break. The kits were distributed worldwide and may pose a risk to patient health.

    Product
    Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRCUMCISION TRAY, Pack Number CIT6860A; 4) CIRCUMCISION TRAY, Pack Number CIT6715; 5) CIRCUMCISION TRAY, Pack Number DYNDA2271; 6) CIRCUMCIS
    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-2776-2024·2024-09-04

    Centurion Procedure Packs with Plastic Syringes Recalled for Leaks and Breakage

    Medline Industries is recalling Centurion procedure packs containing plastic syringes due to leaks, breakage, and quality defects that may pose a risk to patient health. The affected products are distributed worldwide.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHROGRAM TRAY, Pack Number MNS11965A; 3) ARTHROGRAPH TRAY, Pack Number MNS12670A; 4) BREAST BIOPSY KIT, Pack Number DYNDH1512; 5) CIRCUMCISION KIT, Pack Numbe
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2746-2024·2024-09-04

    Medline procedural kits recalled due to defective plastic syringes

    Medline is recalling procedural kits with defective syringes due to leaks and breakage that may pose patient health risks. Affected products include biopsy packs, circumcision trays, and breast biopsy kits.

    Product
    Medline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A; 2) CIRCUMCISION TRAY, Pack Number CIT7210; 3) CIRCUMCISION TRAY, Pack Number DYNDA2271; 4) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 5) UCLA - BREAST BIOPSY KITDYNDH1512A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2627-2024·2024-09-04

    Medline Procedure Packs With Syringes Recalled for Quality Defects

    Medline Industries has recalled over 1.6 million procedure packs containing syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected packs were distributed worldwide.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2624-2024·2024-09-04

    Medical Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage

    Medline Industries is recalling over 1.6 million medical convenience kits containing plastic syringes that may leak or break, posing a potential risk to patient safety. The affected kits are distributed worldwide.

    Product
    see RES for description
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2838-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    Beaver Visitec International recalls BVI CustomEyes Procedure Packs containing Sol-M brand syringes due to manufacturer's voluntary recall. 130 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001020;
    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-2726-2024·2024-09-04

    Stryker iBur Diamond Round surgical bur recalled for thermal overheating risk

    Stryker iBur 4.0mm Diamond Round surgical burs may reach temperatures higher than specified, potentially causing thermal injury or tissue damage during bone-cutting procedures. Approximately 1,706 affected units have been distributed worldwide.

    Product
    Stryker iBur 4.0mm 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)/ Otorhinolaryngology; and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2730-2024·2024-09-04

    Stryker iBur surgical bur may overheat during bone-cutting procedures

    Stryker iBur 3.0mm Diamond Match Head surgical cutting tools may reach temperatures exceeding safe operating limits during bone surgery, potentially causing thermal tissue injury. About 2,507 units worldwide are affected.

    Product
    Stryker iBur 3.0mm Diamond 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)/ Otorhinolaryngology
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2743-2024·2024-09-04

    Medline procedural kit syringes recalled for leaks and breakage

    Medline Industries is recalling multiple surgical procedural kits containing plastic syringes with quality defects. The syringes may leak or break during use, posing a risk to patient safety.

    Product
    Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEART CDS, Pack Number CDS982411N; 3) OPEN HEART, Pack Number CDS983348AA; 4) OPEN HEART, Pack Number CDS983348X; 5) OPEN HEART, Pack Number CDS983348Y; 6) HMT CV SET UP CDS, Pack
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2774-2024·2024-09-04

    Centurion medical syringes recalled for leaks and breakage

    Medline recalls Centurion procedure packs containing Caina syringes due to leaks, breakage, and quality issues that may pose risks to patient health in surgical procedures.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: 1) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 2) RETINAL INJECTION KIT, Pack Number MNS12465
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2775-2024·2024-09-04

    Medical procedure packs containing defective syringes recalled by Medline

    Medline is recalling Centurion procedure packs with plastic syringes that have leaks, breakage, and other quality issues. These defects may pose a risk to patient health.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAST BIOPSY KIT, Pack Name DYNDH1512A; 3) CIRCUMCISION TRAY, Pack Name CIT6720; 4) CIRCUMCISION TRAY, Pack Name CIT6715; 5) CIRCUMCISION TRAY, Pack Name CIT7
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-2767-2024·2024-09-04

    Medical procedure kits with defective plastic syringes recalled due to quality issues

    Medline Industries is recalling Centurion procedure kits due to plastic syringes with defects including leaks and breakage. These defects may compromise patient safety during medical procedures.

    Product
    Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) ARTHROGRAPH TRAY, Pack Number MNS12670A; 5) BIOPSY SKIN/LACER
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2632-2024·2024-09-04

    Medline procedure packs with Shenli syringes recalled for leaks and breakage

    Medline is recalling medical procedure packs containing Shenli syringes due to identified leaks, breakage, and quality issues. These kits may pose a risk to patient health during surgical procedures.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO PACK, Part Number DYNDA1431A; 2) CVC INSERT BUNDLE 16CM, Part Number ECVC3260; 3) CENTRAL LINE INSERTION KIT, Part Number ECVC7440; 4) CENTRAL LINE INSERTION KIT, Part Number ECVC7445;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2614-2024·2024-09-04

    Pediatric Tracheostomy Tubes Recalled Due to Defective Securement Flange

    Smiths Medical recalls pediatric tracheostomy tubes from specific lots due to a manufacturing defect that may cause the securement flange to tear. No injuries have been reported.

    Product
    a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRA
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2771-2024·2024-09-04

    Breast biopsy kits recalled due to defective syringes with leaks and breakage

    Medline Industries recalls Centurion breast biopsy procedure kits due to defective plastic syringes that may leak or break. The syringes are affected by an FDA safety alert and pose potential risks during medical procedures.

    Product
    Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack number BT515A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2864-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes. The voluntary recall affects approximately 1,629 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001376;
    Category
    Medical Device
    Distribution
    Distributed nationwide