The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

8226–8250 of 52968

  • HighFDA (Devices)·Z-2174-2024·2024-07-03

    Blood Glucose Meter Recall: Accu-Chek Guide May Display Incorrect Measurement Units

    Roche is recalling Accu-Chek Guide (SC) blood glucose meters that may display readings in mmol/L instead of mg/dL, appearing approximately 18 times lower than actual. This could lead to incorrect treatment decisions and long-term diabetes complications.

    Product
    Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. Product REF Number: 08453071001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V511000·2024-07-03

    Freightliner Custom Chassis S2C and S2RV Brake Light Recall

    Daimler Trucks North America is recalling 2023-2025 Freightliner Custom Chassis S2C and S2RV trucks because brake lights may not illuminate during active brake assist events.

    Product
    FCCC — FCCC S2C, S2RV
    Category
    Vehicle
    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-2212-2024·2024-07-03

    Medtronic Implantable Defibrillators Recalled for Manufacturing Weld Defect

    Medtronic is recalling 82 implantable cardioverter defibrillators due to a manufacturing defect involving weld cracks discovered during quality control testing before distribution to patients.

    Product
    Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ. b. CLARIA MRI CRT-D SureScan, Model Number DTMA2D1. c. CLARIA MRI QUAD CRT-D SureScan, Model Number DTMA2QQ. d. AMPLIA MRI CRT-D SureScan, Mod
    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-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-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-2222-2024·2024-07-03

    Drainage Catheter Recalled Due to Incorrect Expiration Dates on Labels

    Cook Incorporated is recalling 15 units of the Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter due to incorrect expiration dates on product labels that extend beyond the device's true expiration date. Affected units were distributed to Spain and the Netherlands.

    Product
    Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique. ORDER NUMBER: GPN: G
    Category
    Medical Device
    Distribution
    1 state
  • 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 (Food)·F-1405-2024·2024-07-03

    Wakefield Ham, Egg & Cheese Muffins Recalled for Possible Listeria Contamination

    Classic Delight LLC is recalling 1,366 cases of Wakefield Ham, Egg & Cheese Muffins due to possible Listeria monocytogenes contamination. The affected products were distributed across 14 states.

    Product
    (Item 806604) Wakefield Ham, Egg & Cheese Muffin
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-2204-2024·2024-07-03

    Medtronic Implantable Cardioverter Defibrillator Recalled Due to Weld Crack Defect

    Medtronic is recalling 6 units of the MIRRO MRI VR SureScan implantable cardioverter defibrillator due to a potential manufacturing defect. The devices failed manufacturing quality checks because of a weld crack.

    Product
    MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1423-2024·2024-07-03

    Fresh Catch Inc. Yellowfin Tuna Recalled for High Histamine Levels

    Fresh Catch Inc. is recalling Yellowfin Tuna for high histamine levels. No illnesses have been reported.

    Product
    Fresh Catch Inc. Yellowfin Tuna, 1 loin per case packaged in carboard boxes with keep refrigerated label
    Category
    Food
    Distribution
    1 state
  • 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 cauterizin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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) 2095801-001-0103
    Category
    Medical Device
    Distribution
    0 states
  • 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-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 (Food)·F-1402-2024·2024-07-03

    Wakefield Charbroiled Cheeseburger Kaiser Roll Recalled for Listeria Contamination

    Classic Delight LLC is recalling 3,411 cases of Wakefield Charbroiled Cheeseburger Kaiser Roll due to possible Listeria monocytogenes contamination. The product was distributed in 14 states.

    Product
    (Item 514713) Wakefield Charbroiled Cheeseburger Kaiser Roll
    Category
    Food
    Distribution
    14 states
  • 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-1413-2024·2024-07-03

    Wakefield Bacon Cheeseburger Kaiser Rolls Possibly Contaminated with Listeria

    Classic Delight LLC is recalling Wakefield Bacon Cheeseburger Kaiser Rolls due to possible Listeria monocytogenes contamination. The recall affects 1,079 cases distributed across 14 states.

    Product
    (Item 806653) Wakefield Bacon Cheeseburger Kaiser Roll
    Category
    Food
    Distribution
    14 states
  • HighFDA (Food)·F-1407-2024·2024-07-03

    Wakefield Bacon, Egg & Cheese Bagels Recalled for Possible Listeria Contamination

    Classic Delight LLC is recalling Wakefield Bacon, Egg & Cheese Bagels (Item 806620) due to possible Listeria monocytogenes contamination. The recall affects 2,663 cases distributed across 14 states.

    Product
    (Item 806620) Wakefield Bacon, Egg & Cheese Bagel
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-2196-2024·2024-07-03

    Medtronic EVERA S VR Implantable Cardioverter Defibrillator Recalled for Manufacturing Defect

    Medtronic is recalling EVERA S VR implantable cardioverter defibrillators due to a potential manufacturing defect involving a weld crack that can cause device failure. The defect was identified during manufacturing leak testing.

    Product
    EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1395-2024·2024-07-03

    Classic Delight Breaded Chicken Sliders Recalled for Possible Listeria Contamination

    Classic Delight Twin Breaded Chicken Sliders distributed to institutional food service are being recalled due to possible contamination with Listeria monocytogenes. The recall affects 1,767 cases across 14 states.

    Product
    (Item 6757) Classic Delight Twin Breaded Chicken Sliders - INSTITUTIONAL USE ONLY
    Category
    Food
    Distribution
    14 states