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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8451–8475 of 13652

  • 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-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-1268-2023·2023-09-06

    Siemens Atellica CH Analyzer: Reagent Carryover Affecting Magnesium Test Results

    Siemens Healthcare Diagnostics has recalled the Atellica CH LDL Cholesterol Direct diagnostic device due to reagent carryover affecting magnesium test accuracy. Approximately 8420 units distributed nationwide and internationally are affected.

    Product
    Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097632
    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-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-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-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-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-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-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-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-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-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-2493-2023·2023-09-06

    Olympus Bronchovideoscope Models Recalled for Endotracheal Tube Connector Lodging Risk

    Olympus is recalling 3,652 bronchovideoscope units nationwide due to complaints that the endoscope diameter is too large, creating a risk the scope may become lodged in the endotracheal tube connector.

    Product
    Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2502-2023·2023-09-06

    Olympus Bronchovideoscope Recalled Due to Oversized Diameter

    Olympus is recalling two models of bronchovideoscope (Models BF-3C40 and BF-N20) because the endoscope diameter is too large and may become lodged in the endotracheal tube connector.

    Product
    Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2469-2023·2023-09-06

    GS70 Salus Surgical Table may continue moving after control button release

    The GS70 Salus Surgical Table may continue moving after the control button is released if communication between the control pendant and table is interrupted. This affects 110 units distributed across the US and Australia/New Zealand.

    Product
    GS70 Salus Surgical Table, Product Code 18-070-70
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2504-2023·2023-09-06

    Olympus Tracheal Intubation Fiberscope may lodge in endotracheal tube connector

    Olympus tracheal intubation fiberscope models LF-DP, LF-GP, and LF-TP are being recalled because the endoscope can become lodged in the endotracheal tube connector due to an oversized diameter.

    Product
    Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2497-2023·2023-09-06

    Olympus Bronchovideoscope Model BF-MP190F Recall for Oversized Diameter

    Olympus Corporation recalls 441 Bronchovideoscope Model BF-MP190F units. The endoscope's diameter is too large, causing it to become lodged in the endotracheal tube connector.

    Product
    Olympus Bronchovideoscope, Models BF-MP190F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1269-2023·2023-09-06

    Siemens Atellica CH Total Protein II Recalled for Reagent Carryover

    Siemens Healthcare Diagnostics is recalling Atellica CH Total Protein II due to reagent carryover affecting magnesium test accuracy. The recall covers all lots (13,071 units) distributed nationwide and internationally.

    Product
    Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097604
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2248-2023·2023-08-30

    Carina Sub-Acute Care Ventilator Recalled for Toxic Chemical Emission

    Draeger Medical is recalling 11,621 Carina Sub-Acute Care Ventilators because polyurethane components emit 1,3-Dichloropropan-2-ol at levels exceeding safe limits during extended use in pediatric patients.

    Product
    Carina Sub-Acute Care Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2442-2023·2023-08-30

    EMBLEM MRI S-ICD Pulse Generator Recall for Rare Sensing Disablement

    Boston Scientific recalls the EMBLEM MRI S-ICD Pulse Generator due to a rare interaction with the LATITUDE communicator that may disable the device's sensing capability for up to 24 hours.

    Product
    EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2452-2023·2023-08-30

    IMPIX 3D spinal implant recalled for packaging pinhole defect

    Medicrea International is recalling 248 units of IMPIX 3D intervertebral fusion devices due to pinholes in the product packaging. The recall covers devices distributed nationwide.

    Product
    IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13062810, j) B242C13122810, k) B242C14122810, l) B242C15122810, m) B247C07062
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2449-2023·2023-08-30

    O-arm O2 Imaging System Ground Cable Installation Defect Recall

    Medtronic is recalling O-arm O2 imaging systems due to an incorrectly installed ground cable. The defect affects 28 units distributed across the US and internationally.

    Product
    The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2443-2023·2023-08-30

    Femur nail surgical implant mislabeled with incorrect product length

    Smith & Nephew recalled a femur nail surgical implant because some packages contained a 40cm product instead of the labeled 36cm version. No injuries have been reported.

    Product
    TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
    Category
    Medical Device
    Distribution
    3 states