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.

11651–11675 of 22152

  • HighFDA (Devices)·Z-1722-2024·2024-05-08

    Zimmer surgical fracture plates may fail to lock properly

    Zimmer periarticular locking plates used in orthopedic surgery have a thread defect that may prevent proper locking of screws. The defect could delay surgery or result in loss of fixation requiring additional intervention.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1755-2024·2024-05-08

    Johnson & Johnson Irrigation Sleeve Recalled for Manufacturing Defect

    Johnson & Johnson is recalling 3,428 reusable irrigation sleeves due to manufacturing defects that could impair cooling during eye surgery, potentially causing anterior chamber instability and patient harm.

    Product
    Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0476-2024·2024-05-08

    FDA Issues Nationwide Recall of Subpotent Ophthalmic Eye Drops

    The FDA is recalling 3,320 bottles of compounded ophthalmic solution due to subpotency. The affected product does not contain adequate amounts of active medication.

    Product
    Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1726-2024·2024-05-08

    Zimmer Distal Lateral Fibular Plates May Have Improper Screw Locking

    A thread form defect in the locking holes of Zimmer surgical bone plates may prevent locking screws from securing properly, potentially causing loss of fixation during surgery.

    Product
    ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1724-2024·2024-05-08

    Zimmer ZPLP Fibular Plate May Fail to Lock Properly During Surgery

    The ZPLP Distal Lateral Fibular Plate may have a thread defect preventing screws from locking properly, potentially compromising surgical fixation and requiring further intervention.

    Product
    ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1729-2024·2024-05-08

    Zimmer Distal Lateral Fibular Plate Recall Due to Locking Thread Defect

    Zimmer recalls certain ZPLP Distal Lateral Fibular Plates due to thread form defects in locking holes that may prevent proper screw fixation. Affected devices may lose fixation, potentially delaying surgery or requiring additional intervention.

    Product
    ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1731-2024·2024-05-08

    Medtronic Invos Infant Sensor Cables recalled for manufacturing defects

    Covidien is recalling 1,122 Medtronic Invos Reusable Infant Sensor Adapter Cables due to manufacturing defects in connectors. The defects may cause error codes or non-functioning monitoring channels.

    Product
    Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1715-2024·2024-05-08

    Zimmer Distal Lateral Fibular Plate may fail to lock properly

    Zimmer orthopedic plates may have thread defects preventing locking screws from properly mating, potentially resulting in loss of fixation and need for additional surgery.

    Product
    ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 7-2357-018-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1212-2024·2024-05-08

    Food Club All Purpose Flour recalled for undeclared allergens

    Shawnee Milling Company recalled 3,360 bags of 5 lb. Food Club All Purpose Flour due to undeclared milk, egg, and soy allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    5 lb.Food Club All Purpose Flour Best if Used by 03/08/2025
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1749-2024·2024-05-08

    Radiation therapy planning system doses may be calculated incorrectly

    Certain versions of RayStation radiation therapy planning software may incorrectly report dose-related parameters, potentially affecting treatment calculations. The manufacturer recommends verification of affected systems.

    Product
    RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2024·2024-05-08

    RayStation radiation therapy planning software affected by source-to-surface distance calculation error

    RayStation radiation therapy treatment planning software versions 8.1.0.47, 8.1.1.8, and 8.1.2.5 may calculate source-to-surface distance incorrectly, potentially affecting dose calculations. Approximately 5 units are distributed worldwide.

    Product
    RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1213-2024·2024-05-08

    French's Crispy Fried Onions Recalled for Potential Staphylococcus Growth

    McCormick & Company is recalling French's Crispy Fried Onions due to potential growth of Staphylococcus aureus. The affected product was distributed to consumers in Arizona and Illinois.

    Product
    FRENCH S CRISPY FRIED ONIONS ORIG 16/6 OZ, Case Pack - 16/6 OZ,
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1712-2024·2024-05-08

    Zimmer Distal Lateral Fibular Plate Locking Screw Defect

    Zimmer's Periarticular Locking Plate may have defective locking holes that prevent screws from properly locking, risking loss of bone fixation and requiring additional surgery.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V587000·2024-05-08

    2023 International HV and MV Driveshaft Failure Recall

    Navistar recalls certain 2023 International HV and MV vehicles; driveshafts may break under certain conditions, causing loss of drive power and increasing crash risk. Replacement is free.

    Product
    INTERNATIONAL — 2023 INTERNATIONAL HV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1744-2024·2024-05-08

    Radiation Therapy Planning System May Report Dose Values Too High

    RayStation radiation therapy planning software versions 9.0.0.113 and 9.0.1.142 may report dose values that are higher than actual. The Class II recall affects 63 units distributed worldwide.

    Product
    RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1716-2024·2024-05-08

    Zimmer Locking Plate System Recalls Distal Fibular Plates Due to Thread Defect

    Zimmer recalls distal fibular plates with defective locking holes that may prevent proper screw fixation during orthopedic surgery, potentially requiring additional intervention.

    Product
    ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1747-2024·2024-05-08

    Radiation therapy planning system may calculate patient doses too high

    RayStation versions 10.1.0.613 and 10.1.1.54 may calculate radiation doses higher than intended. Eighteen units have been distributed worldwide to medical facilities.

    Product
    RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V554000·2024-05-07

    2023 Western Star and Freightliner trucks recalled for engine control module defect

    Daimler Trucks North America is recalling 1,375 certain 2023 Western Star and Freightliner commercial trucks due to engine control module defects that can cause unexpected engine shutdown, increasing crash risk.

    Product
    WESTERN STAR — 2023 WESTERN STAR 49X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V552000·2024-05-07

    KZRV Travel Trailers Retractable Awning Seam Separation Drop Hazard

    KZRV is recalling 2022-2023 travel trailers due to electric retractable awnings with defective welded seams that may separate and drop, increasing the risk of injury.

    Product
    KZRV — 2023 KZRV SPORTSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V493000·2024-05-07

    Pleasure Way motorhomes recalled for fuel hose fire risk

    Pleasure Way is recalling certain 2021-2023 OnTour and Lexor motorhomes due to fuel hose defects that may cause gasoline leaks and fire risk. Dealers will inspect and replace fuel hoses free of charge.

    Product
    PLEASURE WAY — 2022 PLEASURE WAY ONTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V490000·2024-05-07

    Grand Design RV Recall: Improperly Tightened Suspension U-Bolts

    Grand Design is recalling certain 2021–2024 Solitude and Momentum fifth wheels with improperly tightened suspension U-bolts. Loose U-bolts can cause the axle to move, leading to loss of vehicle control.

    Product
    GRAND DESIGN — 2023 GRAND DESIGN SOLITUDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V494000·2024-05-07

    2018-2023 Nissan Leaf vehicles recalled for unintentional acceleration risk

    Nissan is recalling certain 2018-2023 Leaf vehicles that may accelerate unintentionally when the driving mode is changed after disengaging cruise control. The defect increases the risk of crashes.

    Product
    NISSAN — 2020 NISSAN LEAF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V556000·2024-05-07

    Electric retractable awning on multiple RV models may separate unexpectedly

    The electric retractable awning on certain 2022–2023 RV models has a welded seam that may separate, allowing the awning to drop beyond normal operation and increase injury risk.

    Product
    FOREST RIVER — 2022 FOREST RIVER FLAGSTAFF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V555000·2024-05-07

    2022 Vanleigh Vilano and Beacon travel trailers awning failure recall

    Vanleigh RV recalls 2022 Vilano and Beacon travel trailers for defective electric retractable awnings that may collapse. The welded seam can fail, creating a fall injury risk.

    Product
    VANLEIGH — 2022 VANLEIGH VILANO
    Category
    Vehicle
    Distribution
    Distributed nationwide