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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5076–5100 of 39844

  • 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-0620-2025·2024-12-11

    Olympus Removes Acecide-C Disinfection from GIF-1TH190 Endoscope Reprocessing

    Olympus has removed high-level disinfection with Acecide-C as an approved reprocessing method for the GIF-1TH190 gastrointestinal videoscope. Approximately 1,770 units nationwide are affected.

    Product
    EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0579-2025·2024-12-11

    Ziehm Vision RFD 3D Hand Switch Defect May Cause Unintended Radiation

    The Ziehm Vision RFD 3D hand switch can fail when exposed to mechanical stress like dropping, potentially initiating unintended radiation from the x-ray system.

    Product
    Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0608-2025·2024-12-11

    GE Healthcare CT Systems Recalled Due to Progressive Image Rotation

    GE Healthcare CT systems may display progressively rotated images, particularly in helical, cine, and cardiac scans. Rotations up to 56 degrees may affect image interpretation and could necessitate additional patient scanning.

    Product
    GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0575-2025·2024-12-11

    X-ray system hand switch may fail, risking unintended radiation exposure

    Three Ziehm Vision x-ray systems have hand switches that may fail under mechanical stress, potentially causing unintended radiation. Owners should verify their serial numbers and contact the manufacturer.

    Product
    Ziehm Vision system, x-ray, tomography, computed.
    Category
    Medical Device
    Distribution
    1 state
  • 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
  • HighFDA (Devices)·Z-0610-2025·2024-12-11

    GE Healthcare Revolution Maxima CT Systems Recalled for Progressive Image Rotation

    GE Healthcare recalled Revolution Maxima and related CT imaging systems that can produce progressively rotated images during helical, cine, and cardiac scans. Approximately 72 units worldwide are affected; no patient injuries reported.

    Product
    GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0584-2025·2024-12-11

    BD EpiCenter Medical Device Software Service Credentials Accessed by Unauthorized Party

    BD EpiCenter software service credentials were accessed by an unauthorized actor. Until credentials are updated, there is risk of unauthorized access to the software and associated data.

    Product
    BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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-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-0633-2025·2024-12-11

    MEDLINE Recalls Medical Convenience Kits Containing Recalled SafeAir Component

    MEDLINE is recalling approximately 25,877 medical convenience kits distributed nationwide that contain SafeAir Smoke Evacuation Pencil components previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2) MAMMOPLASTY-LF, REF CDS983478M; 3) PLASTICS FREE FLAP, REF CDS983493M; 4) PLASTIC TORSO-LF, REF CDS983496L; 5) PLASTIC TORSO-LF, REF CDS983496M; 6) PLASTIC HEAD AND NECK-LF, REF CDS983498N; 7) ACH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0634-2025·2024-12-11

    Medline Convenience Kits Recalled Due to Defective Smoke Evacuation Component

    Medline is recalling 14,388 surgical convenience kits nationwide manufactured with certain lots of SafeAir Smoke Evacuation Pencils previously recalled by Stryker. Affected kits should not be used.

    Product
    MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907K; 3) LKLND SNGL BASIN PK RFID-LF, REF DYNJ0619907L; 4) BASIN SET W/ RING BASIN, REF DYNJ06966M; 5) OPEN HEART C--BASIN PACK-LF, RE
    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-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-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-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-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-0591-2025·2024-12-11

    BD Synapsys Laboratory Informatics System Recalled for Service Credential Compromise

    BD is recalling the Synapsys Informatics Solution Version 444150 due to compromised service credentials used by technical support teams. Unauthorized access may compromise data confidentiality, integrity, and system availability.

    Product
    BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0637-2025·2024-12-11

    MEDLINE Burn Convenience Kits Recalled Due to Defective Component

    MEDLINE is recalling 486 burn convenience kits because they were manufactured using SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331D
    Category
    Medical Device
    Distribution
    Distributed nationwide