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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

9301–9325 of 13683

  • HighFDA (Devices)·Z-1631-2023·2023-05-31

    Medical Device Calibrator Recall for Salicylate Assay Due to Measurement Bias

    Siemens Healthcare is recalling ADVIA Chemistry ToxAmmonia Calibrators due to positive bias in salicylate assay measurements. Affected calibrators were distributed across the US and internationally.

    Product
    ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 10309217
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1625-2023·2023-05-31

    Incisive CT Plus imaging system recalled for potential incorrect image orientation

    Philips is recalling 5 Incisive CT Plus CT X-ray systems due to potential defects that may display images with flipped or reversed orientation, risking misdiagnosis, incorrect treatment, and unnecessary radiation exposure from repeat scans.

    Product
    Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1624-2023·2023-05-31

    Incisive CT Power X-Ray System may display flipped or reversed images

    The Incisive CT Power X-Ray System (Model 728148) may display computed tomography images with incorrect orientation—flipped or reversed—potentially leading to misdiagnosis, incorrect treatment, or additional radiation exposure from rescanning.

    Product
    Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1622-2023·2023-05-31

    Philips CT Scanner May Display Images With Incorrect Orientation

    Philips Incisive CT X-ray systems may display medical images in incorrect orientation, potentially leading to misdiagnosis, incorrect treatment, and unnecessary radiation exposure if rescans are needed.

    Product
    Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1626-2023·2023-05-31

    Diagnostic Cartridge Assay May Fail to Detect Chlamydia Trachomatis Correctly

    Binx Health is recalling a single lot of its CT/NG diagnostic cartridges distributed in Pennsylvania. The cartridges may not accurately detect Chlamydia trachomatis, potentially producing false negative or false positive results.

    Product
    binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1617-2023·2023-05-31

    Omnicell IVX Station medical device recalled for dose accuracy failures

    OmniCell recalls six Omnicell IVX Station devices used for automated pharmaceutical preparation. The devices may not account for scale inaccuracy, potentially allowing incorrect doses to pass quality checks.

    Product
    Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1613-2023·2023-05-31

    Olympus Single Use Distal Cover for Endoscope Recalled Due to Detachment Risk

    Olympus is recalling about 309,278 single-use endoscope covers that may detach during use, risking aspiration, inhalation, obstruction, or burns.

    Product
    Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1619-2023·2023-05-31

    Medical Device Spine Pack Light Handles May Separate During Surgical Use

    Windstone Medical Packaging recalls Aligned Medical Solutions Spine Pack kits due to light handle covers that may separate during surgery. This could delay procedures and compromise the sterile field, potentially injuring patients.

    Product
    Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1615-2023·2023-05-31

    ViziShot 2 Aspiration Needle recalled for manufacturing angle defect

    ViziShot 2 Aspiration Needles are being recalled because the needle angle does not meet specifications and remains unbent, causing resistance during use. No illnesses or injuries have been reported.

    Product
    ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1480-2023·2023-05-31

    Fluoroscopic Imaging System May Display Incorrect Radiation Dose Measurements

    Siemens Luminos dRF Max fluoroscopic imaging systems may occasionally display incorrect radiation dose measurements during certain operating conditions. The manufacturer states the error does not affect diagnosis or workflow.

    Product
    Luminos dRF Max (VE10, VF10, VF11)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1616-2023·2023-05-31

    Olympus Fine Needle Aspiration Needles Recalled for Angle Non-Conformance

    Olympus is recalling 1,297 boxes of fine needle aspiration needles due to a manufacturing defect where the needle angle does not meet specifications, resulting in slight resistance during needle advancement and retraction.

    Product
    To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1632-2023·2023-05-31

    Siemens Atellica CH Toxicology Calibrator Reassignment Due to Positive Bias

    Siemens Healthcare Diagnostics is reassigning Atellica CH Toxicology Calibrators due to a positive bias. The affected calibrators were distributed in the US and internationally across multiple countries.

    Product
    Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, ETOH and Sal assays using the Atellica¿ CH Analyzer Siemens Material Number (SMN): 11099440
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1481-2023·2023-05-31

    LUMINOS Lotus Max fluoroscopic system recalled for sporadic measurement errors

    LUMINOS Lotus Max fluoroscopic systems may sporadically display incorrect radiation dose measurements. The error only occurs with secondary X-ray tubes and does not affect diagnosis or workflow.

    Product
    LUMINOS Lotus Max (VF11)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1479-2023·2023-05-31

    Fluoroscopic imaging system may display incorrect radiation dose readings

    Siemens Luminos Agile Max fluoroscopic imaging systems may occasionally display incorrect radiation dose information under certain unlikely circumstances. The manufacturer states there is no impact on clinical workflow or diagnosis. The error only occurs in systems with a second overhead X-ray tube.

    Product
    Luminos Agile Max (VE10, VF10, VF11)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1447-2023·2023-05-24

    Draeger VentStar Anesthesia Breathing Circuit Connections May Detach

    Draeger Medical recalls VentStar Anesthesia (N) 180 breathing circuits. Glued connections can loosen or detach during ventilation, potentially creating a critical disconnection risk.

    Product
    VentStar Anesthesia (N) 180, MP00333
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1568-2023·2023-05-24

    ASM Replacement Battery Recalled for Manufacturing Defect and Capacity Loss

    ICU Medical is recalling ASM Replacement Batteries due to a manufacturing defect from the battery supplier. Affected batteries may lose capacity and runtime earlier than expected during their lifecycle.

    Product
    ASM Replacement Battery, Component Number SUB0000594
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1567-2023·2023-05-24

    ASM Replacement Battery Recalled for Manufacturing Defect and Capacity Loss

    ICU Medical is recalling the ASM Replacement Battery due to a manufacturing defect from the battery supplier. The defect may cause batteries to lose capacity and experience decreased runtime earlier than expected.

    Product
    ASM Replacement Battery, Component Number SUB0000864
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1440-2023·2023-05-24

    Draeger VentStar Basic ventilator breathing circuit connections may detach during use

    Draeger Medical is recalling 325 VentStar Basic (P)180 ventilators because glued breathing circuit connections can become loose before or during ventilation, potentially causing partial or complete detachment of circuit pieces.

    Product
    VentStar Basic (P)180, MP00351
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1448-2023·2023-05-24

    VentStar Basic Ventilator Recall: Risk of Breathing Circuit Detachment

    Draeger Medical is recalling 1,725 VentStar Basic ventilators because glued breathing circuit connections can become loose and detach before or during ventilation. This may disrupt patient breathing support.

    Product
    VentStar Basic (N) 180, MP00353
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1449-2023·2023-05-24

    VentStar Watertrap breathing circuit connections may detach during ventilation

    Draeger Medical is recalling the VentStar Watertrap (N) 180 due to glued breathing circuit connections that may become loose or detach during ventilation, posing patient safety risk.

    Product
    VentStar Watertrap (N) 180, MP00363
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1445-2023·2023-05-24

    VentStar Breathing Bag Set Recalled for Loose Circuit Connections

    Draeger Medical is recalling VentStar breathing bag sets nationwide due to loose glued connections in the breathing circuit. Connections can detach before or during ventilation.

    Product
    VentStar breathing bag Set (P) 110, MP00384
    Category
    Medical Device
    Distribution
    Distributed nationwide