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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4376–4400 of 13512

  • 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-0586-2025·2024-12-11

    Medical Device Data Management Software Affected by Unauthorized Service Credential Access

    Service credentials for BD EpiCenter Data Management System were accessed by an unauthorized actor. This creates a risk of unauthorized access to the software and associated data until credentials are updated.

    Product
    BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0581-2025·2024-12-11

    BIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach

    Smith & Nephew is recalling BIORAPTOR Suture Anchors due to inadequate packaging design that fails to maintain sterile barriers, potentially contaminating the implant. No injuries or illnesses have been reported.

    Product
    BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0524-2025·2024-12-11

    Fusion Pro 24 Laser Safety Interlock Fails, Allowing Dangerous Radiation Exposure

    Epilog Laser Corp. is recalling Fusion Pro 24 Model 17000 laser systems because an incorrectly placed interlock device allows the front-loading door to open during operation, potentially exposing users to Class 4 laser radiation.

    Product
    Fusion Pro 24, Model 17000
    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-0621-2025·2024-12-11

    BD Bacterial Susceptibility Test Discs Recall for Decreased Potency

    Becton Dickinson recalled BD BBL Sensi Disc Ampicillin 2 μg test discs due to 65% potency loss over 18 months that may produce false resistant results in susceptibility testing.

    Product
    BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. Catalog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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
  • ModerateFDA (Devices)·Z-0555-2025·2024-12-11

    Non-ablative Fractional Laser Systems WFB-01: Software Bug and Labeling Issues Recalled

    Non-ablative Fractional Laser Systems Model WFB-01 are recalled due to a software bug affecting 6 units sold to US customers before August 23, 2022, and labeling non-compliances affecting 22 units sold to US customers.

    Product
    Non-ablative Fractional Laser Systems, Model: WFB-01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0623-2025·2024-12-11

    Medline Medical Convenience Kits Recall Due to Recalled Component

    Medline is recalling certain medical convenience kits manufactured with SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker. The recall affects 182 units distributed nationwide.

    Product
    MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418L; 3) LOCAL BASIC, REF DYNJ34418M; 4) MINI LOCAL, REF DYNJ900287D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0642-2025·2024-12-11

    Medline Surgical Convenience Kits Recalled Over Supplier Component Recall

    Medline is recalling 336 surgical convenience kits manufactured with SafeAir Smoke Evacuation Pencils that Stryker previously recalled. The kits were distributed nationwide.

    Product
    MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYNJ0843760I; 3) PELVISCOPY PACK-LF, REF DYNJ0843760J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0609-2025·2024-12-11

    GE Healthcare Revolution Frontier CT systems may produce rotated images during scans

    GE Healthcare Revolution Frontier CT systems can produce progressively rotated images during helical, cine, and cardiac scans. The rotation can reach up to 56 degrees and may require repeat scans.

    Product
    GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0616-2025·2024-12-11

    GE Healthcare CT Scanner Console Images May Rotate After First Scan

    Certain GE Healthcare CT scanner systems may produce progressively rotated images after the first scan, with rotation up to 56 degrees. While anatomical data remains intact, misaligned images could necessitate patient rescans.

    Product
    GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0614-2025·2024-12-11

    GE Healthcare CT Imaging Systems Recalled for Progressive Image Rotation

    GE Healthcare is recalling operator console upgrades for certain CT systems due to a software defect causing progressive image rotation during scans. Rotations can reach up to 56 degrees and may require patient rescanning.

    Product
    GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, Elite/BrightSpeed Elite Select), Non-EU: BrightSpeed Elite, BrightSpeed Elite Select; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0625-2025·2024-12-11

    MEDLINE Surgical Convenience Kits Recalled for Defective Component

    Medline Industries is recalling 30,092 surgical convenience kits nationwide containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA #11-RF, REF CDS840261AB; 4) HEART CDS, REF CDS840387T; 5) OPEN HEART CDS PART A, REF CDS840402AF; 6) OPEN HEART CDS PART A, REF CDS840402AI; 7) HEART PACK,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0636-2025·2024-12-11

    Medline Colon Wound Closure Packs recalled due to defective component

    Medline is recalling Colon Wound Closure Packs (REF DYNJ52141B) because they were manufactured using SafeAir Smoke Evacuation Pencils that were recalled by Stryker. The kits have been distributed nationwide.

    Product
    MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0588-2025·2024-12-11

    BD COR MX Instruments Affected by Unauthorized Service Credentials Access

    BD recalled its COR MX instruments after an unauthorized actor accessed service credentials. The company is updating credentials to prevent future unauthorized access to product data and systems.

    Product
    BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0602-2025·2024-12-11

    CT Image Rotation Issue in GE Healthcare Optima 680 Systems

    GE Healthcare Optima 680 Expert CT systems may produce progressively rotated images during helical and cardiac scans. Affected images may require rescanning for accurate clinical interpretation.

    Product
    GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0624-2025·2024-12-11

    Medline Surgical Kits Recalled for SafeAir Smoke Evacuation Pencils

    Medline is recalling 1,271 surgical convenience kits containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker. The affected kits were distributed nationwide, and healthcare facilities should discontinue use.

    Product
    MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3) PLASTIC PACK, REFDYNJ58409C; 4) GENDER AFFIRMING SURGERY, REFDYNJ66252A; 5) ST CHARLES PORT, REFDYNJ909591
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0641-2025·2024-12-11

    Medline Surgical Convenience Kits Recalled for Defective Component

    Medline is recalling multiple surgical convenience kits because they contain SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker. The recall affects 1,952 units distributed nationwide; no injuries have been reported.

    Product
    MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MAJOR VAGINAL PACK-LF, REF DYNJ0826768P; 4) VAGINAL PACK, REF DYNJ59081C; 5)VAGINOPLASTY PACK, REF DYNJ65807C; 6) ACH MAJOR VAGINAL PACK, REF DYNJ67757B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0646-2025·2024-12-11

    MEDLINE Surgical Kits Recalled Due to Defective SafeAir Component

    Medline is recalling 3,452 units of surgical convenience kits nationwide due to a defective SafeAir Smoke Evacuation Pencil component previously recalled by Stryker. No illnesses or injuries have been reported.

    Product
    MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 6) D&C/HYSTEROSCOPY PACK, REF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0648-2025·2024-12-11

    Medline Recalls Convenience Kits with Recalled SafeAir Smoke Evacuation Pencil

    Medline is recalling 1,921 medical convenience kits distributed nationwide that contain SafeAir Smoke Evacuation Pencil components previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATARACT PACK, REF DYNJ43147G; 4) OSC OCULOPLASTIC PACK, REF DYNJ63329D; 5) OSC OCULOPLASTIC PACK, REF DYNJ63329F; 6) OCULAR PACK, REF DYNJ64138B; 7) OSC BRE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0594-2025·2024-12-11

    BD BACTEC FX40 Product Service Credentials Accessed by Unauthorized Actor

    Unauthorized actor accessed BD technical support credentials for the BACTEC FX40 laboratory instrument. Until credentials are updated, there is a risk of unauthorized access to the system and associated data.

    Product
    BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0587-2025·2024-12-11

    BD COR PX Instrument Service Credentials Compromised; Update Required

    Becton Dickinson reports that technical support credentials for the BD COR PX Instrument were accessed by an unauthorized actor. Users should verify credential updates with BD to mitigate unauthorized access risk.

    Product
    BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988
    Category
    Medical Device
    Distribution
    Distributed nationwide