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.

7626–7650 of 52968

  • HighFDA (Devices)·Z-2703-2024·2024-08-28

    Medline medical procedure kits recalled for dimensional variation affecting canister fit

    Medline Industries recalled 6,998 medical procedure kits worldwide due to slight dimensional variations that may cause difficulty fitting into outer canisters. The Class II recall affects multiple procedure kit types distributed in the US and internationally.

    Product
    Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; c) ENT, REF DYNJ909935; d) NASAL SINUS-LF, REF DYNJ902624G; e) ORAL, REF DYNJ902377I; f) PACK,BRONCHOSCOPY, REF DYNJ65475B; g) PACK,HEAD AND NECK, REF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2716-2024·2024-08-28

    Philips Allura Xper Interventional Fluoroscopy Systems Recalled for Incorrect Bolt

    Philips Allura Xper systems contain an incorrect half-threaded bolt in LTE kits instead of the required full-threaded bolt. Six units distributed worldwide have been affected.

    Product
    Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2682-2024·2024-08-28

    BIOFIRE FILMARRAY Pneumonia Panel Recalled for Manufacturing Defect

    BioFire Diagnostics is recalling 58 units of BIOFIRE FILMARRAY Pneumonia Panel due to a manufacturing defect that increases the risk of control failures and delayed test results.

    Product
    BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2686-2024·2024-08-28

    Diagnostic Test Kit May Produce False Results in Tuberculosis Drug Resistance Testing

    The BD BACTEC MGIT 960 PZA Kit may intermittently produce falsely resistant results when testing TB susceptibility to pyrazinamide. This Class II recall affects 12,383 units distributed worldwide.

    Product
    BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2693-2024·2024-08-28

    IBA Proton Therapy System PROTEUS 235 Collision Detection Malfunction

    FDA recalls 19 units of the IBA Proton Therapy System PROTEUS 235 due to occasional failures in collision detection for the Forte Robotic Patient Positioning System affecting facilities across multiple US states and internationally.

    Product
    IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2672-2024·2024-08-28

    FDA Recalls Alcon Ophthalmic Knives for Decreased Blade Sharpness

    Alcon is recalling 1,061 ophthalmic surgical knives due to reports of decreased sharpness. The affected instruments are used in eye surgery procedures and may not perform as intended.

    Product
    Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2666-2024·2024-08-28

    Alcon ophthalmic surgical knives recalled for sharpness defect

    Alcon is recalling 145,248 ophthalmic knives (CLEARCUT SATINSLIT model 8065992745) due to increased complaint reports of inadequate sharpness. The surgical instruments were distributed nationwide and internationally.

    Product
    Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Catalog Number: 8065992745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2650-2024·2024-08-28

    Ophthalmic Knives Recalled Due to Complaints About Reduced Sharpness

    Alcon is recalling ophthalmic knives for increased complaints of reduced sharpness. These surgical instruments require consistent blade sharpness for surgical precision in eye procedures.

    Product
    Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Model/Catalog Number: 8065772245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2675-2024·2024-08-28

    Ophthalmic surgical knives recalled due to reported sharpness defects

    Alcon is recalling specific ophthalmic surgical knives due to reported sharpness defects. The recall affects 3,791 units distributed nationwide and internationally.

    Product
    Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2652-2024·2024-08-28

    Alcon Ophthalmic Surgical Knives Recalled for Inadequate Sharpness Defect

    Alcon is recalling specific ophthalmic knives due to reports of inadequate sharpness. The affected instruments may not function as intended during surgical procedures.

    Product
    Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number: 8065772445 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V642000·2024-08-27

    Kentucky Trailer Recalls 2022-2024 MV and PV Truck Bodies for Floor Defect

    Kentucky Trailer is recalling 2022-2024 MV and PV truck bodies because the upper cargo floor may not be secured properly, allowing crossmembers to loosen and detach.

    Product
    KENTUCKY TRAILER — KENTUCKY TRAILER MV, PV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V641000·2024-08-27

    Jayco motorhome rearview camera image may not display

    Jayco is recalling certain 2023-2025 Entegra Ethos, Ethos LI, Arc, Jayco Swift, Swift LI and Comet motorhomes because radio software may prevent the rearview image from displaying, failing FMVSS 111.

    Product
    JAYCO — JAYCO, ENTEGRA SWIFT LI, ETHOS LI, ETHOS, COMET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V640000·2024-08-26

    Toyota Sequoia Hybrid tow hitch covers may come loose and detach

    Toyota is recalling certain 2023-2024 Sequoia Hybrid vehicles with a tow hitch cover attached to the rear bumper because the cover may come loose and detach from the vehicle.

    Product
    TOYOTA — TOYOTA SEQUOIA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V634000·2024-08-23

    Ford fuel injectors assembled without O-ring support discs may leak

    Ford is recalling certain Lincoln Corsair, Escape, Mustang and Explorer vehicles because fuel injectors may have been assembled without O-ring support discs. 24 units affected.

    Product
    FORD — FORD, LINCOLN MUSTANG, ESCAPE, EXPLORER, CORSAIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V635000·2024-08-23

    Ford EcoBoost engine intake valves may break while driving

    Ford is recalling certain 2021-2022 vehicles with 2.7L or 3.0L Nano EcoBoost engines because the engine intake valves may break, resulting in engine failure and loss of drive power.

    Product
    FORD — FORD, LINCOLN EDGE, BRONCO, NAUTILUS, AVIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24E073000·2024-08-23

    Navico Recalls Progressive RV Surge Protectors Due to Ground Contact Defect

    Navico Group is recalling Progressive RSM-30 and PSK-30 surge protectors for recreational vehicles because the ground contact may fail, increasing the risk of electrical shock.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24348·2024-08-22

    Shawshank LEDz Squeeze Plush Ball Toys Recalled for Injury Hazard

    Shawshank LEDz is recalling approximately 9,600 Squeeze Plush Ball toys sold at Ace Hardware because the toys contain liquid and glitter that can splash out if the membrane ruptures, potentially injuring a child's eyes and face.

    Product
    Squeeze Plush Ball Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24346·2024-08-22

    Siemens SolarReady Meter Combos Recalled Due to Fire Hazard

    Siemens is recalling about 3,910 SolarReady Meter Combos because an interior connection can overheat and pose a fire hazard. The firm has received eight reports of overheating, including one localized fire, but no injuries.

    Product
    Siemens SolarReady Meter Combos
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2575-2024·2024-08-21

    Merit Medical Cardiac Catheter Kits Recalled for Syringe Leaks and Breakage

    Merit Medical's Prelude SNAP-H cardiac catheter kits are being recalled because their syringes may leak or break during use, potentially affecting cardiac procedures. No illnesses have been reported.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP-H (Introducer Catheter kit), REF: PLSH-1006/A PLSH-1007/A PLSH-1008/A PLSH-1009.5/A PLSH-2506/A PLSH-2507/A For the introduction of various t
    Category
    Medical Device
    Distribution
    Distributed nationwide