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.

8251–8275 of 52968

  • 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
    14 states
  • 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-1428-2024·2024-07-03

    Cream Cheese Stuffed Mini Bagels Recalled for Undeclared Gluten

    FEEL GOOD FOODS INC is recalling Cream Cheese Stuffed Everything Mini Bagels nationwide because the product contains gluten not listed on the label. Consumers with gluten sensitivity should not consume this product.

    Product
    Cream Cheese Stuffed Everything Mini Bagels
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2186-2024·2024-07-03

    Siemens Multix TOP X-ray Table Recalled Due to Fire Risk

    Siemens is recalling 3 Multix TOP I PRO radiographic X-ray tables due to a short circuit in the Touch Display power supply unit that may cause overheating and fire.

    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:475517
    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-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 (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-2170-2024·2024-07-03

    Patient Monitors May Fail to Display Vitals After Power Loss

    GE Healthcare is recalling certain CARESCAPE Canvas patient monitors that may fail to display vital signs after a power loss if the CPU battery has been replaced. This could delay recognition of changes in patient condition.

    Product
    CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01080402, e) 5514418-01081317, f) 5514418-01086007, g) 5514418-01086838, h) 5514418-01088182, i) 5514418-01108442, j) 5514418-01118673, k) 5514418-01120764
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-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 (Drugs)·D-0564-2024·2024-07-03

    Buprenorphine Injection Recalled Due to Incomplete Seal Integrity Issue

    Pfizer is recalling specific lots of Buprenorphine Hydrochloride Injection due to potential incomplete crimp seals that could compromise product sterility. Patients using affected lots should consult their healthcare provider.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    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-2202-2024·2024-07-03

    Implantable Cardioverter Defibrillator Recalled Due to Manufacturing Weld Defect

    Medtronic is recalling 26 MIRRO MRI DR SureScan Implantable Cardioverter Defibrillators due to a manufacturing defect involving a weld crack that could affect device function.

    Product
    MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1414-2024·2024-07-03

    Wakefield Sausage and Egg Pancake Recalled for Possible Listeria Contamination

    Classic Delight LLC recalls Wakefield Sausage & Egg Pancake products (Item 942821) due to possible Listeria monocytogenes contamination. Affected products were distributed across 14 states.

    Product
    (Item 942821) Wakefield Sausage & Egg Pancake
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-2216-2024·2024-07-03

    NovaGuide 2 Ultrasound Systems Recalled for Electrical Shock Risk

    FDA is recalling 45 NovaGuide 2 Intelligent Ultrasound systems due to a defective grounding cable that could become disconnected and cause electrical shock, electrical interference, or equipment malfunction.

    Product
    NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2194-2024·2024-07-03

    Medtronic COBALT XT Heart Devices Recalled Due to Manufacturing Defect

    Medtronic is recalling 58 COBALT XT HF QUAD implantable cardioverter defibrillators worldwide due to a weld crack manufacturing defect that caused devices to fail quality checks.

    Product
    COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1396-2024·2024-07-03

    Classic Delight Breaded Chicken Waffle Recalled for Possible Listeria Contamination

    Classic Delight Breaded Chicken Waffle (Item 7626) for institutional use is being recalled due to possible contamination with Listeria monocytogenes. The recall affects 644 cases distributed to institutions in 14 states.

    Product
    (Item 7626) Classic Delight Breaded Chicken Waffle - INSTITUTIONAL USE ONLY
    Category
    Food
    Distribution
    14 states
  • HighFDA (Food)·F-1406-2024·2024-07-03

    Wakefield Ham, Egg & Cheese Croissant Recalled for Listeria Contamination

    Classic Delight LLC recalls Wakefield Ham, Egg & Cheese Croissants due to possible Listeria monocytogenes contamination. The product was distributed across 14 US states; consumers with affected products should not consume them.

    Product
    (Item 806612) Wakefield Ham, Egg & Cheese Croissant
    Category
    Food
    Distribution
    14 states
  • HighFDA (Food)·F-1416-2024·2024-07-03

    Turkey Sausage & Egg Muffins Recalled for Possible Listeria Contamination

    Classic Delight LLC is recalling 16,572 cases of Turkey Sausage & Egg Muffins (Item 73131) distributed across 14 states due to possible Listeria monocytogenes contamination.

    Product
    (Item 73131) Turkey Sausage & Egg Muffin
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-2183-2024·2024-07-03

    Siemens AXIOM MULTIX MP X-ray Tables Recalled for Power Supply Fire Risk

    Siemens Medical Solutions is recalling AXIOM MULTIX MP radiographic X-ray tables due to a potential short circuit in the power supply that may cause overheating and fire. The recall includes 20 units with U.S. nationwide distribution.

    Product
    AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395431
    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-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 (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