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.

27176–27200 of 50462

  • HighFDA (Devices)·Z-0232-2019·2018-10-31

    Ecolab Camera Arm Drapes Recalled for Potential Sterility Breach

    Ecolab is recalling specific lots of Camera Arm Drapes because wrinkles in the packaging seal could compromise the product's sterility.

    Product
    Camera Arm Drape (Box of 20) 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 cover/wrap…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0255-2019·2018-10-31

    McCain Foods Recalls Fire-Roasted Red Onion and Pepper Blend

    McCain Foods USA is recalling Fire-Roasted Red Onion & Pepper Blend because it was released after presumptive positive tests for Listeria and Salmonella without confirmation.

    Product
    Fire-Roasted Red Onion & Pepper Blend: Sold in 2 lb. containers. Brand Name: Hot Stuff Foods¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0323-2019·2018-10-31

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

    McCain Foods USA is recalling Fire-Roasted Home-Style Yellow Pepper Strips because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella.

    Product
    Fire-Roasted Home-Style Yellow Pepper Strips;: Sold in 20 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0250-2019·2018-10-31

    McCain Foods Recalls Fire-Roasted Chili Due to Pathogen Testing Failures

    McCain Foods USA is recalling Fire-Roasted Rubio's Fresno Chili because finished product was released after presumptive positive tests for Listeria and Salmonella without confirmation.

    Product
    Fire-Roasted Rubio's Fresno Chili ; Sold in 2 lb. containers. Brand Name: Chef Sensations¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0273-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems for 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 Bl70000027100 SYSTEM lOOV, Model Number Bl70000027100 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 from 2D…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Food)·F-0218-2019·2018-10-31

    McCain Recalls Fire Roasted Diced Green Peppers Due to Pathogen Testing Issues

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

    Product
    Fire Roasted 1/2" Diced Green Peppers: Sold in 25 lb. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0251-2019·2018-10-31

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

    McCain Foods USA is recalling Fire Roasted Green Pepper Strips because products were released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire Roasted Green Pepper Strips ; Sold in 2 lb. containers. Brand Name: Jon-Lin¿ NatureSmart¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0258-2019·2018-10-31

    McCain Recalls Fire-Roasted Red Pepper Strips Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire-Roasted Home-Style Red Pepper Strips because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella.

    Product
    Fire-Roasted Home-Style Red Pepper Strips;: Sold in 20 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0230-2019·2018-10-31

    McCain Foods Recalls Caramelized Diced Onions Due to Listeria and Salmonella

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

    Product
    Caramelized 1/4" Diced Onions; Sold in 25 lb. containers. Brand Name:Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0213-2019·2018-10-31

    Siemens APTIO 9000 Refrigerated Storage Module Recall for Missing Warning Label

    Siemens Healthcare Diagnostics is recalling 441 APTIO 9000 Refrigerated Storage Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    APTIO 9000 REFRIGERATED STORAGE MODULE
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Food)·F-0220-2019·2018-10-31

    McCain Foods Recalls Fire-Roasted Onion and Pepper Strip Blend

    McCain Foods USA is recalling Fire-Roasted Onion/Pepper Strip Blend due to potential Listeria and Salmonella contamination discovered during an internal audit.

    Product
    Fire-Roasted Onion/Pepper Strip Blend: Sold in 20 lb. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0235-2019·2018-10-31

    McCain Recalls Fire Roasted Diced Green Zucchini Due to Listeria and Salmonella

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

    Product
    Fire Roasted 1/2" Diced Green Zucchini ; Sold in 25 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0242-2019·2018-10-31

    Custom Healthcare Systems Recalls Convenience Kits Due to Sterility Compromise

    Custom Healthcare Systems is recalling specific lots of CHS Custom Convenience Kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-0224-2019·2018-10-31

    McCain Recalls Fire Roasted Onion Strips Due to Listeria and Salmonella

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

    Product
    FIRE ROASTED ONION STRIPS: Sold in 20 lb. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0327-2019·2018-10-31

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

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

    Product
    Fire-Roasted Red Jalapeno Slices; Sold in 2 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0271-2019·2018-10-31

    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 reported software anomalies affecting startup, communication, and imaging functions.

    Product
    O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 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 from 2D and…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Food)·F-0242-2019·2018-10-31

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

    McCain Foods USA is recalling Fire-Roasted Diced Organic Onions after an internal audit revealed products were released following presumptive positive tests for Listeria and Salmonella without confirmation.

    Product
    Fire-Roasted 3/8" Diced Organic Onions; Sold in 25 lb. containers. Brand Name: Jon-Lin¿ NatureSmart¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0240-2019·2018-10-31

    Custom Healthcare Systems Recalls Convenience Kits Due to Sterility Compromise

    Custom Healthcare Systems is recalling 200 units of CHS Custom Convenience Kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Product Number: B9-15934B
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0203-2019·2018-10-31

    Data Innovations Recalls Abbott Alinity ci-series Software Driver

    Data Innovations is recalling a software driver for Abbott Alinity ci-series instruments that fails to process quality control results, potentially delaying or causing incorrect patient treatment.

    Product
    IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).
    Category
    Medical Device
    Distribution
    1 state