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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9276–9300 of 40056

  • HighFDA (Devices)·Z-2476-2023·2023-09-06

    Siemens epoc BGEM BUN Test Card Glucose Measurement Inaccuracy Recall

    Siemens Healthcare Diagnostics recalls 3,201 epoc BGEM BUN Test Cards due to potential for inaccurately high glucose readings in low-glucose samples.

    Product
    epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2474-2023·2023-09-06

    Siemens Atellica CH diagnostic reagent carryover may cause false laboratory test results

    Siemens has recalled 18,524 units of its Atellica CH HDL Cholesterol diagnostic device due to potential reagent carryover that could produce false test results in patient samples and quality control testing.

    Product
    Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Material Number (SMN): 11537213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2495-2023·2023-09-06

    Olympus Airway Mobilescope models may become lodged in connectors

    Olympus Airway Mobilescope endoscopes may become lodged in endotracheal tube connectors due to oversized diameter affecting airway management procedures nationwide.

    Product
    Olympus Airway Mobilescope, Models MAF-GM & MAF-TM.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2468-2023·2023-09-06

    Chevalier Valvulotome Surgical Instrument Recalled Due to Burr Defect

    LeMaitre Vascular is recalling certain Chevalier Valvulotome surgical instruments used in vein-graft procedures due to burrs on the cutting tip that may tear the harvested vein. The recall affects 225 units distributed internationally.

    Product
    The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an invert
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2498-2023·2023-09-06

    Olympus Bronchovideoscope Recalled Due to Lodging Risk in Airway

    Olympus is recalling Bronchovideoscope Model BF-XT190 units because the device diameter is too large, causing the endoscope to become lodged in endotracheal tube connectors.

    Product
    Olympus Bronchovideoscope, Models BF-XT190.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2470-2023·2023-09-06

    Skytron GS70H Surgical Table Recall: Control Failure Causes Continued Movement

    The Skytron GS70H Salus Surgical Table may continue moving after the control button is released when operating in Bluetooth mode or when communication is interrupted. The defect could cause unexpected table movement during surgery.

    Product
    GS70H Salus Surgical Table, Product Code 18-071-70
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2503-2023·2023-09-06

    Olympus Bronchovideoscope Recalled for Risk of Lodging in Airway Connector

    Olympus Corporation is recalling 1,004 units of the Bronchovideoscope Model BF-3C160 due to a dimensional defect that can cause the endoscope to become lodged in an endotracheal tube connector.

    Product
    Olympus Bronchovideoscope, Models BF-3C160.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1271-2023·2023-09-06

    Atellica CH Triglycerides_2 Reagent Recalled Due to Magnesium Test Interference

    Siemens Healthcare Diagnostics is recalling 5,315 units of Atellica CH Triglycerides_2 diagnostic reagent due to reagent carryover that can affect magnesium test results. The product was distributed nationwide and internationally.

    Product
    Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum and plasma (lithium heparin, sodium heparin, potassium EDTA) using the Atellica CH Analyzer. SMN: 11537222
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2479-2023·2023-09-06

    PASCAL Transcatheter Valve Repair System Affected by Manufacturing Defect

    Edwards Lifesciences is recalling 92 units of the PASCAL Precision Transcatheter Valve Repair System due to a manufacturing defect in the release mechanism that could cause increased resistance and potential improper implant positioning.

    Product
    PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2481-2023·2023-09-06

    Surgical Rasp Handle May Fracture Due to Weld Crack

    The Link OptiStem Rasp Handle used in knee replacement surgery may develop a crack in the weld that causes the handle to fracture. If this occurs, surgical removal of the rasp must be modified, potentially prolonging the procedure.

    Product
    Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2494-2023·2023-09-06

    Olympus Bronchovideoscope Recall Due to Device Lodging Risk

    Olympus is recalling Bronchovideoscope Models BF-UC180F and BF-UC190F because the device diameter is too large and can become lodged in the endotracheal tube connector. Healthcare facilities should discontinue use and contact Olympus.

    Product
    Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2486-2023·2023-09-06

    Cardiosave Hybrid Intra-Aortic Balloon Pump Fiber Optic Sensor Failure

    Datascope Corp. is recalling 9,379 Cardiosave Hybrid Intra-Aortic Balloon Pumps due to a fiber optic sensor failure that may occur when inserting the balloon connector.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2475-2023·2023-09-06

    LIF AMP Adjustable Awl Recalled for Assembly Defect Preventing Depth Control

    Alphatec Spine is recalling the LIF AMP Adjustable Awl due to an assembly defect preventing the locking feature from engaging. This prevents proper depth control during surgery and risks dural tears, vascular injury, and neurologic damage.

    Product
    LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2477-2023·2023-09-06

    FDA Recalls Siemens epoc BGEM Crea Test Cards for Inaccurate Glucose Results

    Siemens Healthcare is recalling epoc BGEM Crea Test Cards that may produce inaccurate glucose readings in lower-range samples. 473 units were distributed to US facilities and international locations. No injuries reported.

    Product
    epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2484-2023·2023-09-06

    Oculus Myopia Master optical device recalled for insufficient anti-reflective coating

    Oculus Optikgeraete GMBH is recalling 173 units of the Oculus Myopia Master optical measurement device due to insufficient anti-reflective coating that may cause incorrect axial length measurements.

    Product
    Oculus Myopia Master , Ref 68100, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2500-2023·2023-09-06

    Olympus Bronchovideoscope Models Risk Device Lodging in Airway

    Olympus Corporation is recalling 3,949 Bronchovideoscope units nationwide because the endoscope diameter is too large, causing potential lodging in endotracheal tube connectors.

    Product
    Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2487-2023·2023-09-06

    Intra-Aortic Balloon Pumps Fiber Optic Sensor Input Failure Recalled

    Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps because users reported failure of the fiber optic sensor input when inserting the balloon connector. This could affect proper device operation.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2482-2023·2023-09-06

    Medical Device Recall: Oculus Pentacam AXL Wave Measurement Inaccuracy

    Oculus Pentacam AXL Wave optical devices may have insufficient anti-reflective coating, potentially causing inaccurate axial length measurements used in eye surgery planning.

    Product
    Oculus Pentacam AXL Wave, Ref 70020, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2512-2023·2023-09-06

    Phoroptor VRx Digital Refraction System head detachment hazard recall

    Reichert's Phoroptor VRx Digital Refraction System head may detach from its mounting bracket and fall onto patients or operators. The recall affects 87 units distributed nationwide.

    Product
    PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye. MODEL NUMBER: 16242 [Model 16241 is the base model. Model 16242 includes an additional prism feature used for the measurement of ocular deviation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2483-2023·2023-09-06

    Oculus Pentacam AXL optical devices recalled for measurement accuracy issues

    Oculus Pentacam AXL optical devices with insufficient anti-reflective coating may produce incorrect axial length measurements, affecting 364 units distributed nationwide.

    Product
    Oculus Pentacam AXL , Ref 70100, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2489-2023·2023-09-06

    Upper roller bracket for Radixact gantry enclosure may lack adequate service clearance

    Accuray is recalling upper roller brackets for the Radixact Treatment Delivery System because they may not provide sufficient clearance for service personnel to safely use equipment during maintenance, creating a possible injury risk.

    Product
    Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2478-2023·2023-09-06

    Siemens epoc BGEM Test Card recalled for glucose measurement inaccuracy

    Siemens Healthcare Diagnostics is recalling epoc BGEM Test Cards for veterinary use due to potential inaccurate glucose results in lower-range samples. Affected units may report artificially elevated readings.

    Product
    epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2465-2023·2023-09-06

    LifeSPARC Cardiac Pump Recalled Due to Uncured Epoxy Manufacturing Defect

    Cardiac Assist, Inc. is recalling the LifeSPARC Pump due to uncured epoxy used during manufacturing that may cause early device failure. Two units were distributed in Illinois and Florida.

    Product
    LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TAND
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1270-2023·2023-09-06

    Atellica CH Triglycerides Diagnostic Kit Recalled for Reagent Carryover

    Siemens Healthcare Diagnostics is recalling 11,824 units of Atellica CH Triglycerides test kits due to reagent carryover from other test parameters that can affect magnesium measurement accuracy. The FDA classified this as a Class II recall.

    Product
    Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma (lithium heparin, potassium EDTA) using the Atellica CH Analyzer SMN: 11097591
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2464-2023·2023-09-06

    Oncology Software Allergy Warnings May Not Display for Medication Ingredients

    RayCare oncology software versions 5A, 5B, and 6A may fail to display medication allergy warnings under certain circumstances. Healthcare facilities could inadvertently prescribe medications patients are allergic to.

    Product
    RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2,
    Category
    Medical Device
    Distribution
    Distributed nationwide