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.

1501–1525 of 21623

  • HighFDA (Devices)·Z-1536-2026·2026-03-18

    [pending] GEM Premier 5000; Part No: 00055415011.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1536-2026.

    Product
    GEM Premier 5000; Part No: 00055415011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1549-2026·2026-03-18

    [pending] Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16

    Pending LLM rewrite. Source: FDA_DEVICE Z-1549-2026.

    Product
    Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1544-2026·2026-03-18

    [pending] PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016

    Pending LLM rewrite. Source: FDA_DEVICE Z-1544-2026.

    Product
    PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1498-2026·2026-03-18

    [pending] Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)006287580

    Pending LLM rewrite. Source: FDA_DEVICE Z-1498-2026.

    Product
    Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DI code: (01)00628758003335 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1537-2026·2026-03-18

    [pending] GEM Premier 5000; Part No. 00055430004.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1537-2026.

    Product
    GEM Premier 5000; Part No. 00055430004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0400-2026·2026-03-18

    [pending] ICOSAPENT ETHYL (ICOSAPENT ETHYL)

    Pending LLM rewrite. Source: FDA_DRUG D-0400-2026.

    Product
    ICOSAPENT ETHYL — ICOSAPENT ETHYL (ICOSAPENT ETHYL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0614-2026·2026-03-18

    CNC Noodle Corporation Fresh Noodles Recall for Undeclared Allergens

    CNC Noodle Corporation is recalling ZHONG HUA CHAO MIAN fresh noodles due to undeclared wheat and Yellow #6 food coloring on the label. Consumers with wheat allergies or sensitivities to the colorant may be at risk.

    Product
    Secondary Packaging: ZHONG HUA CHAO MIAN NOODLE INGREDIENTS: ENRICHED FLOUR, WATER, STARCH, SALT, POTASSIUM, CARBONATE AND BENZOATE OF SODA ADDED AS PRESERVATIVE F.D. & C. YELLOW COLOR #5 & #5 (TARTRAZINE) ARTIFICIAL COLORS) Primary Packaging: CHINA NOODLE CO. FRESH NOODLE NET W
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·H-0550-2026·2026-03-18

    Frozen Raw Blueberry Crumble Pie Recalled for Listeria Risk

    Willamette Valley Pie Company is recalling frozen raw blueberry crumble pies due to potential listeria monocytogenes contamination. The pies were distributed to grocery store in-store bakeries in Illinois and Oregon.

    Product
    Frozen Raw Bulk 8 inch Blueberry Crumble Pie (4 pies/case). Net wt. 24.5oz. UPC 0002251881223. Handmade - Willamette Valley Pie Company LLC. 1651 Eska Way, Silverton, OR. Frozen Raw pies were sold frozen in bulk packaging to grocery retailers' in-store bakeries. They are intende
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1557-2026·2026-03-18

    [pending] HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBAS

    Pending LLM rewrite. Source: FDA_DEVICE Z-1557-2026.

    Product
    HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 /
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1546-2026·2026-03-18

    [pending] Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement

    Pending LLM rewrite. Source: FDA_DEVICE Z-1546-2026.

    Product
    Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/RE4H01P-43, PROCURE TRUE METRIX PRO Meter Only/RE4212P-00, Henry Schein TRUE MET
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1503-2026·2026-03-18

    [pending] Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC,

    Pending LLM rewrite. Source: FDA_DEVICE Z-1503-2026.

    Product
    Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1497-2026·2026-03-18

    [pending] IBA Proton Therapy System - PROTEUS 235

    Pending LLM rewrite. Source: FDA_DEVICE Z-1497-2026.

    Product
    IBA Proton Therapy System - PROTEUS 235
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0551-2026·2026-03-18

    Frozen Blueberry Crumble Pie Recalled for Listeria Risk

    Willamette Valley Pie Company is recalling Frozen Raw Bulk 9 inch Blueberry Crumble Pie due to potential contamination with listeria monocytogenes. The frozen pies were sold to grocery retailers' in-store bakeries in Illinois and Oregon.

    Product
    Frozen Raw Bulk 9 inch Blueberry Crumble Pie ES (4 pies/case). Net wt. 38oz. UPC 00022518893257. Handmade - Willamette Valley Pie Company LLC. 1651 Eska Way, Silverton, OR. Frozen raw pies were sold frozen in bulk packaging to grocery retailers' in-store bakeries. They are inte
    Category
    Food
    Distribution
    2 states