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.

27151–27175 of 50462

  • HighFDA (Food)·F-0328-2019·2018-10-31

    McCain Foods Recalls Fire-Roasted Diced Red Onions Due to Pathogen Testing Failures

    McCain Foods USA is recalling Fire-Roasted 1/2" Diced Red Onions because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire-Roasted 1/2" Diced Red Onions; Sold in 25 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0217-2019·2018-10-31

    McCain Foods Recalls Fire-Roasted Diced Onions Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire-Roasted 1/2" Diced Onions because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire-Roasted 1/2" Diced Onions: Sold in 25 lb. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0278-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to software anomalies affecting startup, communication, and imaging functions.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Food)·F-0253-2019·2018-10-31

    McCain Recalls Fire Roasted Yellow Pepper Strips Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire Roasted Yellow Pepper Strips because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire Roasted Yellow Pepper Strips; Sold in 20 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0204-2019·2018-10-31

    ESAOTE MyLab Alpha Ultrasound System Recalled for Probe Overheating Risk

    ESAOTE S.P.A. is recalling 10 MyLab Alpha Model 7400 ultrasound systems because probe power monitoring settings may cause the probe head to overheat during continuous operation.

    Product
    MyLab Alpha, Model 7400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0254-2019·2018-10-31

    McCain Recalls Fire-Roasted Corn and Black Bean Blend for Pathogen Testing Failures

    McCain Foods USA is recalling Fire-Roasted Corn & Black Bean Blend because products were released after presumptive positive tests for Listeria and Salmonella without confirmation.

    Product
    Fire-Roasted Corn & Black Bean Blend; Sold in 2 lb. containers. Brand Name: Jon-Lin¿ NatureSmart¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0245-2019·2018-10-31

    McCain Recalls Fire Roasted Red Onion Sticks Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire Roasted Red Onion Sticks because products were released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire Roasted Red Onion Sticks; Sold in 25 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0211-2019·2018-10-31

    McCain Foods Recalls Caramelized Diced Onions Due to Listeria and Salmonella

    McCain Foods USA is recalling 77,900 cases of Jon-Lin brand caramelized diced onions because products were released after presumptive positive tests for Listeria monocytogenes and Salmonella.

    Product
    Caramelized 3/8" Diced Onions: Sold in 25 lb. . packages. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0234-2019·2018-10-31

    Ecolab Recalls Da Vinci Robotic System Disposable Accessory Kits

    Ecolab is recalling specific lots of Disposable Accessory Kits for the Da Vinci Si Robotic system because wrinkles in the packaging seal could compromise sterility.

    Product
    Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0256-2019·2018-10-31

    Custom Healthcare Systems Recalls 50 Curved Pean Forceps Kits

    Custom Healthcare Systems is recalling 50 units of curved pean forceps kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669
    Category
    Medical Device
    Distribution
    9 states
  • HighNHTSA·18V771000·2018-10-31

    Kia Recalls 2019 Forte Vehicles for Headlight Aiming Defect

    Kia is recalling 2019 Forte vehicles with LED headlights because they may not be aimed correctly, potentially reducing driver visibility and increasing crash risk.

    Product
    KIA — KIA FORTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0234-2019·2018-10-31

    McCain Recalls Organic Diced Onions Due to Listeria and Salmonella Testing Issues

    McCain Foods USA is recalling Sautéed 3/8" Diced Organic Onions because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Saut¿ed 3/8" Diced Organic Onions; Sold in 25 lb. containers. Brand Name: Jon-Lin¿ NatureSmart¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0252-2019·2018-10-31

    McCain Recalls Fire-Roasted Green Jalapeno Slices Due to Listeria and Salmonella

    McCain Foods USA is recalling 14,172 cases of Fire-Roasted Green Jalapeno Slices because products were released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire-Roasted Green Jalapeno Slices; Sold in 20 lb. containers. Brand Name: Jon-Lin¿ NatureSmart¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0553-2016·2018-10-31

    GE Healthcare 3.0T MRI Flex Coil Recalled for Overheating Risk

    GE Medical Systems is recalling 90 MRI coils because they may overheat in Mode 2, posing a risk of thermal injury to patients.

    Product
    GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0206-2019·2018-10-31

    ESAOTE MyLab Seven Ultrasound System Recalled for Probe Overheating Risk

    ESAOTE is recalling 10 MyLab Seven ultrasound systems because probe power monitoring settings may cause the probe head to overheat during continuous operation.

    Product
    MyLab Seven, Model 6400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2019·2018-10-31

    Canon MRI Systems Recall Due to SAR Display Error

    Canon Medical System is recalling 252 MRI systems because the displayed SAR value may be lower than the actual value, potentially exceeding safety limits.

    Product
    Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body.
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-0267-2019·2018-10-31

    CHS Custom Convenience Kits Recalled Due to Sterility Compromise

    Custom Healthcare Systems is recalling 4,500 fenestrated drape kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-0243-2019·2018-10-31

    McCain Foods Recalls Fire Roasted Diced Poblanos Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire Roasted 1/4" Diced Poblanos because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire Roasted 1/4" Diced Poblanos; Sold in 25 lb. containers. Brand Name: Jon-Lin¿ NatureSmart¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0245-2019·2018-10-31

    Custom Healthcare Systems Recalls Cast Padding Kits Due to Sterility Compromise

    Custom Healthcare Systems is recalling 30 units of cast padding kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-0216-2019·2018-10-31

    McCain Foods Recalls Smokehouse Roasted Diced Apples Due to Pathogen Testing Failures

    McCain Foods USA is recalling Smokehouse Roasted Diced Apples because internal audits revealed products were released after presumptive positive tests for Listeria and Salmonella without confirmation.

    Product
    Smokehouse Roasted 5/8" Diced Apples: Sold in 25 lb. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states