The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

10751–10775 of 27206

  • HighFDA (Devices)·Z-2184-2024·2024-07-03

    Medical imaging system recalled for power supply fire risk

    Siemens is recalling 2 AXIOM Vertix MD imaging systems nationwide due to a potential fire hazard from a short circuit in the power supply unit that may cause overheating.

    Product
    AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: MD39543
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2169-2024·2024-07-03

    GE CARESCAPE Canvas Smart Display monitors may fail to restart after power loss

    GE CARESCAPE Canvas Smart Display monitors may fail to turn on after a power loss, particularly following battery replacement, potentially delaying recognition of patient condition changes.

    Product
    CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2209-2024·2024-07-03

    Implantable defibrillator recalled for manufacturing defect causing device failure risk

    Medtronic is recalling five implantable defibrillators due to a manufacturing defect where weld cracks caused devices to fail quality testing. The defective devices were identified during manufacturing and did not reach patients.

    Product
    Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2191-2024·2024-07-03

    Medtronic COBALT XT HF CRT-D implantable defibrillator recalled for manufacturing defects

    Medtronic is recalling 8 units of the COBALT XT HF CRT-D MRI SureScan implantable cardioverter defibrillator due to manufacturing defects identified during quality control testing.

    Product
    COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2214-2024·2024-07-03

    RAPIDPoint 500e diagnostic system mislabels capillary blood samples as arterial

    Siemens RAPIDPoint 500e software version 5.3 incorrectly labels capillary blood samples as arterial on laboratory information system displays, potentially leading to misinterpretation of results and diagnostic errors.

    Product
    Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint 500e Blood Gas System (ROW) 11416755 ;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1408-2024·2024-07-03

    Frozen Sausage, Egg & Cheese Biscuits Recalled for Possible Listeria Contamination

    Wakefield Sausage, Egg & Cheese Biscuit (Item 806638) has been recalled in 14 states due to possible Listeria monocytogenes contamination. Affected products have best-by dates from February 2024 through March 2025.

    Product
    (Item 806638) Wakefield Sausage, Egg & Cheese Biscuit
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2182-2024·2024-07-03

    Radiographic X-ray Table Recalled Due to Fire Hazard in Power Supply

    Siemens AXIOM MULTIX MP radiographic X-ray tables are being recalled due to a potential short circuit in the touch display's power supply unit that may cause overheating or fire. 12 units nationwide are affected.

    Product
    AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395381
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2189-2024·2024-07-03

    Infinity M500 Cardiac Monitor Poses Electrical Shock Risk

    Draeger recalls 34,102 Infinity M500 monitoring systems due to electrical safety noncompliance. The devices pose a potential risk of electrical shock, burns, and cardiac arrhythmia.

    Product
    Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2024·2024-07-03

    Medtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Defect

    Medtronic is recalling eight COBALT XT VR MRI SureScan implantable cardioverter defibrillators due to weld cracks that caused device failure during manufacturing.

    Product
    COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2207-2024·2024-07-03

    Medtronic COBALT DR MRI SureScan ICD Recalled Due to Manufacturing Weld Crack

    Medtronic is recalling 36 COBALT DR MRI SureScan implantable cardioverter defibrillators due to a weld crack manufacturing defect. The defect was identified during manufacturing quality checks.

    Product
    COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2193-2024·2024-07-03

    Implantable Defibrillator Recalled for Manufacturing Weld Crack Defect

    Medtronic is recalling 11 units of the COBALT XT HF QUAD CRT-D MRI SureScan implantable cardioverter defibrillator due to a manufacturing defect involving weld cracks that failed quality control testing.

    Product
    COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2024·2024-07-03

    D*Clot® HD Rotational Thrombectomy System Recalled for Sterility Barrier Defect

    Mermaid Medical is recalling 190 D*Clot® HD Rotational Thrombectomy Systems worldwide due to failed sterility testing that indicates the sterility barrier may not be fully intact.

    Product
    The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rotatable radiopaque spiral shaft extends ending in an eccentric blunt distal tip. Once activated, the s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1419-2024·2024-07-03

    Gluten-Contaminated Aussie Bites Bakery Product Recall Due to Allergen Mislabeling

    Universal Bakery Organic Aussie Bites are being recalled because they are labeled as gluten-free but testing found gluten content above 20 parts per million. The product was distributed to Washington and Illinois.

    Product
    Universal Bakery Organic Aussie Bites, 30 oz clamshell container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1427-2024·2024-07-03

    Cream Cheese Stuffed Plain Mini Bagels Recalled for Undeclared Gluten

    FEEL GOOD FOODS INC is recalling Cream Cheese Stuffed Plain Mini Bagels due to undeclared gluten. Consumers with gluten sensitivity or celiac disease should not consume this product.

    Product
    Cream Cheese Stuffed Plain Mini Bagels
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2181-2024·2024-07-03

    Siemens X-ray Table Recalled for Fire Hazard in Power Supply

    Siemens recalls AXIOM MULTIX MT radiographic X-ray tables due to a short circuit in the power supply unit that may cause overheating and fire. 7 units are affected nationwide.

    Product
    AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395415
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1410-2024·2024-07-03

    Wakefield Charbroiled Cheeseburgers Recalled Due to Listeria Contamination Risk

    Classic Delight LLC is recalling 1,626 cases of Wakefield Charbroiled Cheeseburgers due to potential Listeria monocytogenes contamination. The product was distributed to 14 states; consumers should discard affected items.

    Product
    (Item 806679) Wakefield Charbroiled Cheeseburger
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2195-2024·2024-07-03

    Medtronic Implantable Defibrillator Recalled for Manufacturing Weld Defect

    Medtronic recalls 26 units of CROME HF QUAD CRT-D implantable defibrillators worldwide due to weld cracks discovered during manufacturing quality control. Devices were contained before reaching patients.

    Product
    CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2211-2024·2024-07-03

    Medtronic ICD Implants Recalled for Manufacturing Weld Crack Defects

    Medtronic recalls 9 units of CROME VR MRI SureScan implantable cardioverter defibrillators due to a manufacturing weld crack that caused devices to fail quality control leak testing.

    Product
    CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2221-2024·2024-07-03

    Endoscopic Kittner Surgical Instrument Recalled for Sterile Barrier Defect

    ASPEN SURGICAL is recalling 1,900 units of the Endoscopic Kittner Blunt Dissecting Instrument (Model KT-9101) due to a potential defect in the sterile barrier seal.

    Product
    Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2190-2024·2024-07-03

    Medtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect

    Medtronic recalled 14 COBALT HF QUAD CRT-D MRI SureScan implantable defibrillators due to a weld crack manufacturing defect detected during quality control testing.

    Product
    COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2218-2024·2024-07-03

    Prelude Roadster Guide Sheaths Recalled Due to Instruction Defect

    Merit Medical Systems is recalling Prelude Roadster Guide Sheaths due to an instructional defect. Older instructions directing tight connection assembly may cause over-tightening, leading to swivel nut detachment.

    Product
    Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F45MP -PG6F45R -PG6F45S -PG6F45S018 -PG6F65MP -PG6F65S -PG6F65SX -PG6F90MP -PG6F90MPX -PG6F90SX -PG6F90SX018 -PG7F45MP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2219-2024·2024-07-03

    Stryker Hoffman LRF Wire Tensioner Adjustment Ring May Become Loose

    Stryker is recalling 39 Hoffman LRF Wire Tensioner devices because the adjustment ring may loosen, preventing proper tension setting. No injuries reported.

    Product
    Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1430-2024·2024-07-03

    Chef Select Herb Baguettes Recalled for Undeclared Wheat and Milk Allergens

    Lidl US TRADING is recalling approximately 2,000 units of Chef Select 2 Herb Baguettes due to undeclared wheat and milk allergens resulting from foreign language labeling. Consumers with wheat or milk allergies should not consume this product.

    Product
    Chef Select 2 Herb Baguettes Filled With Herb Butter 2x175 g Barcode: 4056489447566. Frozen product packaged in a plastic bag, 2 baguettes per unit.
    Category
    Food
    Distribution
    9 states