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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7976–8000 of 27393

  • 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-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-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-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
  • 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-1629-2023·2023-05-31

    Arjo Portable Scale Adaptor Model 700.05725 Recalled for Potential Strap Detachment

    Arjohuntleigh Magog, Inc. is recalling certain Arjo Portable Scale Adaptors due to straps with potential to detach. Three units were distributed in Ohio and New York.

    Product
    Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible patient lifting equipment
    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-1620-2023·2023-05-31

    Aligned Medical Solutions hand pack light covers may separate during use

    Windstone Medical Packaging recalls the Aligned Medical Solutions Minor Hand Pack because light handle covers may detach during procedures. This could delay surgery and compromise the sterile field, risking patient injury.

    Product
    Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO
    Category
    Medical Device
    Distribution
    1 state
  • 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-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-1590-2023·2023-05-24

    Impella 5.5 with SmartAssist Catheter Recalled for Heightened Purge Leak Rate

    Abiomed is recalling 610 units of the Impella 5.5 with SmartAssist catheter due to a heightened complaint rate for purge leaks. This intravascular pump provides circulatory support during critical care.

    Product
    Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1446-2023·2023-05-24

    ID Circuit Basic breathing circuit recalled for loose glued connections

    Draeger Medical is recalling ID Circuit Basic breathing circuits due to glued connections that can loosen during ventilation, potentially causing partial or complete detachment of circuit pieces.

    Product
    ID Circuit Basic (P) 180, MP01340
    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
  • SevereFDA (Devices)·Z-1441-2023·2023-05-24

    VentStar Basic ventilator breathing circuit connections may detach

    Draeger Medical is recalling 200 units of the VentStar Basic ventilator due to glued breathing circuit connections that can loosen or detach before or during ventilation.

    Product
    VentStar Basic (P)250, MP00352
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1444-2023·2023-05-24

    Anesthesia Ventilator Breathing Circuit Connections May Detach During Use

    Draeger Medical is recalling 130 units of the VentStar Anesthesia WT ventilator due to a defect where glued breathing circuit connections may loosen or detach during ventilation, potentially compromising anesthesia delivery.

    Product
    VentStar Anesthesia WT (P)180, MP00374
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1457-2023·2023-05-24

    Ventstar Coax 230 breathing circuit connections can detach during ventilation

    The FDA is recalling Draeger Medical's Ventstar Coax 230 breathing circuit components due to glued connections that can become loose and detach during ventilation, potentially compromising patient breathing support.

    Product
    Ventstar Coax 230, MP03376
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1565-2023·2023-05-24

    Replacement Battery in Plum 360 Infusion System Recalled for Capacity Loss

    ICU Medical Inc is recalling 28,656 replacement batteries used in the Plum 360 Infusion System due to a manufacturing defect that causes premature capacity loss and decreased runtime. Affected units are distributed worldwide.

    Product
    Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1450-2023·2023-05-24

    Draeger VentStar Breathing Circuit Connections May Loosen During Use

    Draeger Medical is recalling the VentStar Bag Set because glued connections on the breathing circuit can become loose or detach during ventilation, potentially compromising respiratory support.

    Product
    VentStar Bag Set (N) 110, MP00383
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1566-2023·2023-05-24

    Plum A+ & A+3 Infusion System Batteries Recalled Due to Manufacturing Defect

    ICU Medical Inc is recalling replacement batteries used in Plum A+ and A+3 infusion pump systems. A manufacturing defect may cause batteries to lose capacity earlier than expected.

    Product
    Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 11973
    Category
    Medical Device
    Distribution
    0 states