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.

Filters

Agency

Category

Minimum severity

Clear filters

4351–4375 of 13526

  • HighFDA (Devices)·Z-0606-2025·2024-12-11

    CT imaging system issue causes progressive image rotation during scans

    GE Healthcare CT systems have a technical issue causing progressive image rotation during helical and cardiac scans. No injuries reported, but unnoticed rotation could affect diagnosis or require rescans.

    Product
    GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0578-2025·2024-12-11

    Ziehm Vision RFD X-ray System Hand Switch May Cause Unintended Radiation

    Orthoscan's Ziehm Vision RFD fluoroscopic x-ray systems may have wired hand switches that fail under mechanical stress, potentially causing unintended radiation. The manufacturer is recalling affected units in the U.S. and Puerto Rico.

    Product
    Ziehm Vision RFD. Interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0643-2025·2024-12-11

    MEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Component

    MEDLINE is recalling surgical convenience kits nationwide because they contain smoke evacuation pencil components from a Stryker product that was previously recalled. The affected kits are used in robotic and laparoscopic surgical procedures.

    Product
    MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC PROCEDURE, REF CDS982128P; 5) ROBOTIC, REF CDS984262N; 6) GYN LAPAROSCOPY, REF CDS984900M; 7) GYN LAP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0638-2025·2024-12-11

    MEDLINE medical convenience kits recalled for defective component

    Medline is recalling medical convenience kits (CLEAN CLOSING PACK and CLEAN CLOSURE PACK GREEN) distributed nationwide because they contain a SafeAir Smoke Evacuation Pencil component that was recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84667
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0649-2025·2024-12-11

    Medline recalls surgical kits containing Stryker smoke evacuation pencil component

    Medline is recalling medical convenience kits containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 3) BASIC BACK CDS, REF CDS780147N; 4) INSTRUMENTED BACK CDS, REF CDS780148Q; 5) INSTRUMENTED BACK CDS, REF CDS780148R; 6) TOTAL HIP, REF CDS920027W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0611-2025·2024-12-11

    GE Healthcare CT System May Produce Rotated Diagnostic Images

    GE Healthcare's Revolution Maxima M and related CT systems may produce progressively rotated images during scans, potentially compromising diagnostic accuracy. Rotation increases with each image, reaching up to 56 degrees.

    Product
    GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0632-2025·2024-12-11

    MEDLINE Port Insertion Pack Recalled for Defective Component

    Medline is recalling 44 PORT INSERTION PACK kits nationwide. These kits contain SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2025·2024-12-11

    BD COR GX Instrument recalled due to compromised service credentials

    Becton Dickinson recalls the BD COR GX Instrument due to unauthorized access to product service credentials. Until credentials are updated, there is a risk of unauthorized device access and potential impact to data security.

    Product
    BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0603-2025·2024-12-11

    GE Healthcare Revolution ACE CT Systems Image Rotation Issue

    GE Healthcare's Revolution ACE CT systems can produce progressively rotated images during certain scan modes. Maximum rotation reaches 56 degrees, potentially affecting diagnostic interpretation.

    Product
    GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0592-2025·2024-12-11

    BD Phoenix M50 Automated Microbiology System Service Credentials Exposed

    BD confirmed that service credentials used by technical support teams were accessed by an unauthorized actor, creating a risk of unauthorized access to BD microbiology systems and associated data.

    Product
    BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0582-2025·2024-12-11

    Cook Medical HEMO-7-EU Hemospray Devices Recalled for Activation Knob Defect

    Cook Medical HEMO-7-EU Hemospray devices are being recalled because the activation knob may crack or break during use due to manufacturing defects. The affected devices were distributed to Argentina, Brazil, and Israel.

    Product
    Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0607-2025·2024-12-11

    GE Healthcare CT Imaging System May Produce Rotated Medical Images

    GE Healthcare CT systems may produce progressively rotated images during helical, cine, and cardiac scans. The issue affects 4 units worldwide and can cause rotations up to 56 degrees.

    Product
    GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0577-2025·2024-12-11

    Fluoroscopic X-ray System Hand Switch May Fail and Cause Unintended Radiation

    The Ziehm Vision R fluoroscopic x-ray system has a hand switch that may fail under mechanical stress and cause unintended radiation. Ziehm Imaging, Inc. is recalling 5 affected units distributed in the U.S.

    Product
    Ziehm Vision R. Iterventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0598-2025·2024-12-11

    Cartiva Synthetic Cartilage Implants Recalled Due to Higher Complication Rates

    Cartiva Synthetic Cartilage Implants are being recalled due to higher-than-expected rates of complications including implant displacement, subsidence, nerve damage, and fragmentation. Patients with these implants should consult their surgeon.

    Product
    Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0605-2025·2024-12-11

    GE Healthcare Revolution Ascend CT System Recalled for Image Rotation

    GE Healthcare Revolution Ascend CT systems can produce progressively rotated images during helical, cine, and cardiac scans. Images after the first may be rotated up to 56 degrees, potentially affecting diagnostic accuracy.

    Product
    GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0628-2025·2024-12-11

    MEDLINE dental and oral surgery kits recalled due to defective component

    MEDLINE is recalling four types of dental and oral surgery convenience kits that were manufactured using SafeAir Smoke Evacuation Pencils, which were previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL PK, REF DYNJ80226A; 4) DENTAL MINOR PACK, REF DYNJ83140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0593-2025·2024-12-11

    BD BACTEC FX Instrument Top credential compromise enables unauthorized access risk

    BD service credentials for BACTEC FX instruments were accessed by an unauthorized actor, creating risk of unauthorized system access until credentials are updated.

    Product
    BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0626-2025·2024-12-11

    Medline recalls surgical convenience kits with defective smoke evacuation component

    Medline is recalling five types of medical convenience kits because they contain the SafeAir Smoke Evacuation Pencil, which Stryker subsequently recalled.

    Product
    MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3) MAJOR VASCULAR PACK-LF, REF DYNJ0488546K; 4) PEDS CENTRAL LINE PACK, REF DYNJ84762; 5) PACK,CENTRAL LINE, REF DYNJ906907C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0585-2025·2024-12-11

    BD EpiCenter Data Management System Credential Compromise Poses Unauthorized Access Risk

    Service credentials for the BD EpiCenter Data Management System were accessed by an unauthorized actor. Until credentials are updated, system data and access controls are at risk.

    Product
    BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0615-2025·2024-12-11

    GE Healthcare CT Operator Console Update: Images May Rotate Progressively

    GE Healthcare operator console upgrades for certain CT systems can cause progressive image rotation during scans. Images may rotate up to 56 degrees per exam, potentially affecting diagnostic accuracy.

    Product
    GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0599-2025·2024-12-11

    Atellica CH β2-Microglobulin Reagent Produces Falsely Depressed Results

    Siemens Atellica CH β2-Microglobulin reagent may produce falsely depressed test results for samples between 18-30 mg/L, potentially leading to missed or delayed kidney disease diagnoses. No illnesses have been reported.

    Product
    Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0612-2025·2024-12-11

    GE Healthcare CT systems produce progressively rotated images in scan modes

    Certain GE Healthcare CT systems can produce progressively rotated images during helical and cardiac scans. Images may rotate up to 56 degrees, potentially affecting diagnosis if the rotation is not detected.

    Product
    GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0604-2025·2024-12-11

    CT imaging systems may display progressively rotated images in certain scan modes

    Certain GE Healthcare CT systems may display progressively rotated images, particularly during helical, cine, or cardiac scans. The rotation increases with each image, potentially reaching 56 degrees maximum.

    Product
    GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0601-2025·2024-12-11

    GE Healthcare Optima 520 CT systems recalled for image rotation

    GE Healthcare recalled 11 Optima 520 CT systems that produce progressively rotated scan images in helical, cine, and cardiac modes, potentially affecting diagnostic accuracy.

    Product
    GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0583-2025·2024-12-11

    Spectral CT Devices Pose Collision and Misdiagnosis Software Risks

    Philips Spectral CT and Spectral CT Plus devices may fail to update plan positioning during interventional procedures, creating collision risks to operators and patients. A software defect may also assign incorrect patient IDs, potentially causing misdiagnosis.

    Product
    Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
    Category
    Medical Device
    Distribution
    Distributed nationwide