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.

12576–12600 of 88183

  • HighFDA (Devices)·Z-2188-2024·2024-07-03

    Siemens AXIOM Vertix Solitaire Display Fire Risk from Power Supply Short Circuit

    Siemens is recalling the AXIOM Vertix Solitaire diagnostic imaging component due to a short circuit in the Touch Display's power supply unit that may cause overheating and fire. Two units with serial numbers 1239 and 1241 are affected.

    Product
    ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emergency and accident patients as well as for use in outpatient departments Material Number: 5901900
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1394-2024·2024-07-03

    Ready-to-Eat Turkey and Cheese Sandwiches Recalled for Possible Listeria Contamination

    Classic Delight LLC is recalling 384 cases of Classic Delight Turkey & Cheese On Round Bun (Item 6731) due to possible contamination with Listeria monocytogenes. The product was distributed to food service facilities in 14 states.

    Product
    (Item 6731) Classic Delight Turkey & Cheese On Round Bun - INSTITUTIONAL USE ONLY
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-2199-2024·2024-07-03

    Implantable Cardioverter Defibrillator with Weld Crack Defect Recalled

    Medtronic is recalling 40 EVERA MRI S DR SureScan ICDs (Model DDMC3D4) due to manufacturing weld cracks that caused devices to fail leak tests. The defect was identified during manufacturing; no patient harm has been reported.

    Product
    EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2192-2024·2024-07-03

    Medtronic Implantable Defibrillator Recalled Due to Manufacturing Weld Crack

    Medtronic is recalling 14 Cobalt XT HF CDT-D MRI SureScan implantable defibrillators due to a manufacturing weld defect that could cause device failure.

    Product
    Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2180-2024·2024-07-03

    X-ray Table Touch Display Power Supply Fire Hazard

    Siemens is recalling AXIOM MULTIX MT X-ray patient tables due to a potential short circuit in the Touch Display power supply that may cause overheating and fire. Fifty units were distributed 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: 8395399
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2197-2024·2024-07-03

    Medtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect

    Medtronic is recalling 14 units of EVERA MRI S VR SureScan implantable cardioverter defibrillators (Model DVMC3D4) due to potential weld cracks discovered during manufacturing. No patient injuries have been reported.

    Product
    EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2187-2024·2024-07-03

    X-ray table recalled for fire hazard from power supply unit short circuit

    Siemens MULTIX TOP I PRO X-ray tables are recalled due to a power supply short circuit that may cause overheating and fire. Three units have been identified.

    Product
    MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 475525
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2205-2024·2024-07-03

    Medtronic MIRRO MRI ICD devices recalled for manufacturing weld crack defect

    Medtronic recalls 13 MIRRO MRI VR SureScan implantable cardioverter defibrillators (ICDs) due to a manufacturing weld crack. The defect was identified and caused device failure during the manufacturing leak check quality control test.

    Product
    MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2198-2024·2024-07-03

    Medtronic EVERA MRI implantable defibrillator recalled for manufacturing weld defect

    Medtronic is recalling five units of its EVERA MRI S DR SureScan implantable cardioverter defibrillator due to a manufacturing defect—a weld crack that caused failure during quality control testing.

    Product
    EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1412-2024·2024-07-03

    Blazin' Chicken Kaiser Rolls Recalled for Possible Listeria Contamination

    Classic Delight LLC is recalling 1,477 cases of Blazin' Chicken Kaiser Rolls due to possible Listeria monocytogenes contamination. The affected product has been distributed across multiple states.

    Product
    (Item 806661) Wakefield Blazin' Chicken Kaiser Roll
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-2203-2024·2024-07-03

    Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect

    Medtronic recalls 46 PRIMO MRI VR SureScan implantable cardioverter defibrillators due to a manufacturing defect. Weld cracks identified during manufacturing quality checks could cause device failure.

    Product
    PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2217-2024·2024-07-03

    NovaGuide 2 Ultrasound System Recall Due to Grounding Cable Disconnection Risk

    NovaGuide 2 Traditional Ultrasound systems may have grounding cables that can be inadvertently disconnected during use, creating risk of electrical shock and equipment malfunction. Twenty-eight systems have been distributed nationwide.

    Product
    NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2168-2024·2024-07-03

    GE CARESCAPE Canvas monitors may lose display following power loss events

    GE Healthcare medical monitors may fail to display following a power loss event after CPU battery replacement, potentially delaying patient condition recognition.

    Product
    CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e) 5865770-01054698; f) 5865770-01054721; g) 5865770-01054740; h) 5865770-01055202; i) 5865770-01055204; j) 5865770-01055270; k) 5865770-01055317; l)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0568-2024·2024-07-03

    Duloxetine Prescription Capsules Recalled Nationwide for Nitrosamine Impurity

    Golden State Medical Supply is recalling Duloxetine 30mg capsules nationwide due to contamination with N-nitroso-duloxetine, a nitrosamine impurity above the FDA's proposed safety limit. Affected lots expire January 31, 2025.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1400-2024·2024-07-03

    Wakefield Bacon, Egg & Cheese Bagels recalled for possible Listeria contamination

    Classic Delight LLC is recalling 2,311 cases of Wakefield Bacon, Egg & Cheese Bagels (Item 514711) due to possible Listeria monocytogenes contamination. The affected product was distributed across 14 states.

    Product
    (Item 514711) Wakefield Bacon, Egg & Cheese Bagel
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-2171-2024·2024-07-03

    GE CARESCAPE Monitors May Fail to Power On After Battery Replacement

    GE Healthcare recalls CARESCAPE B650 patient monitors that may fail to power on after mains power loss following CPU timekeeper battery replacement, potentially delaying recognition of patient condition changes.

    Product
    CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-01023150, 4) 2095801-001-01023151, 5) 2095801-001-01023152, 6) 2095801-001-01032962, 7) 2095801-001-01033915, 8) 2095801-001-01034302, 9)…
    Category
    Medical Device
    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-2176-2024·2024-07-03

    VASOVIEW HemoPro harvesting system fluid ingress may disable cautery

    Maquet Cardiovascular recalls VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems due to fluid ingress into the harvesting tool handle, which may prevent necessary cautery or cause unintended cautery during surgical procedures.

    Product
    The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2185-2024·2024-07-03

    AXIOM Vertix Solitaire Medical Imaging Device Recall: Fire Risk from Power Supply Defect

    Siemens is recalling 4 AXIOM Vertix Solitaire medical imaging devices due to a short circuit in the touch display power supply that may cause overheating and fire. Units with serial numbers 1004, 1006, 1011, and 1014 are affected.

    Product
    AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: 8627718
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2201-2024·2024-07-03

    Medtronic MIRRO MRI implantable defibrillator recalled for weld defect

    Medtronic is recalling 3 MIRRO MRI DR SureScan implantable cardioverter defibrillators due to a manufacturing weld crack that caused devices to fail quality checks. The defect was detected during manufacturing before devices reached patients.

    Product
    MIRRO MRI DR SureScan, Model Number DDME3D1, 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-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 (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