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.

5176–5200 of 52956

  • HighFDA (Devices)·Z-1211-2025·2025-03-05

    Tyber Medical recalls A.L.P.S. mvX Anatomic Lateral Fibula Plates due to screw malposition

    Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates (418 units, nationwide) because the locking screw may pass through the locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2025·2025-03-05

    PENTAX Medical Video Upper GI Endoscope Thermal Burn Risk Recall

    Pentax of America is recalling 138 PENTAX Medical Video Upper GI Scopes due to a thermal injury risk. The light guide tip can become excessively hot during endoscopic procedures, potentially burning patient tissue.

    Product
    PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0576-2025·2025-03-05

    Deiorio Foods Cauliflower Shells Recalled for Plastic Fragment Contamination

    Deiorio Foods is recalling 1701 cases of 5912MOD-CAU 11" Gluten Free Friendly Cauliflower Shells due to potential contamination with white plastic fragments. The product may pose a choking hazard.

    Product
    5912MOD-CAU 11" Gluten Free Friendly Cauliflower Shell; Bulk packaged in a blue poly bag, within a corrugated box. 20 units per case; Product UPC: 074542659125; Master Case GTIN: 00074542659125
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0583-2025·2025-03-05

    Rajbhog Sweets Jelebi Jaggery recalled due to undeclared milk allergen

    Rajbhog Distributors TX Inc. recalls Rajbhog Sweets Jelebi Jaggery for containing undeclared milk, an allergen that can trigger allergic reactions in sensitive consumers.

    Product
    Rajbhog Sweets Jelebi Jaggery, 9.5 oz packages and sold by weight from bulk trays.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1223-2025·2025-03-05

    FDA Recalls Medial Tibia Plates for Intra-operative Screw Failure

    Tyber Medical is recalling A.L.P.S. mvX Medial Tibia Plates due to reports that the locking screw can pass through the locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770715121
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1217-2025·2025-03-05

    Orthopedic Plate Locking Screw May Pass Through Hole During Surgery

    Tyber Medical is recalling A.L.P.S. mvX-P Anatomic Lateral Fibula Plates because the locking screw may pass through the locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate, 12-Hole, Left. Inended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708121
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2025·2025-03-05

    GE Healthcare MRI system recalled for RF energy safety control failure

    GE Healthcare's Optima MR360 MRI systems may allow unsafe RF energy exposure if a scan resumes after power loss. The user interface can incorrectly enable scanning when tissue-heating levels exceed safe limits.

    Product
    Optima MR360, NMRI system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2025·2025-03-05

    Medical plate locking screw may fail during fracture surgery

    A locking screw in the A.L.P.S. mvX Medial Tibia Plate may pass through its locking hole during surgery. Surgical delays have been reported with this device.

    Product
    A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate, 16-Hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715161
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1210-2025·2025-03-05

    Orthopedic fibula plate locking screw failure during surgery

    Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates due to locking screw passing through the locking hole intra-operatively, causing surgical delays. The recall affects 397 units distributed nationwide.

    Product
    A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole, Right Model/Catalog Number: 770708042
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1207-2025·2025-03-05

    Automated Medication Cabinet Recalled Due to Fingerprint Scanner Overheating Risk

    CareFusion's BD Pyxis MedFlex automated medication cabinet is being recalled due to fingerprint scanner failure and overheating, posing a potential fire hazard in clinical settings.

    Product
    BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing Cabinet (ADC) intended to securely store and dispense medications and supplies to a qualified and authorized user in a clinical setting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1220-2025·2025-03-05

    Medial tibia plate screw locking defect causes surgical delays

    Tyber Medical is recalling A.L.P.S. mvX Medial Tibia Plates because the locking screw may pass through the locking hole during surgery instead of securing properly, causing surgical delays. The recall affects 210 units distributed nationwide.

    Product
    A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Model/Catalog Number: 770715062 Intended for Fixation of fractures of the distal tibia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1224-2025·2025-03-05

    A.L.P.S. mvX Medial Tibia Plate Locking Screw Malfunction Recall

    Tyber Medical recalls 208 units of A.L.P.S. mvX Medial Tibia Plates due to locking screws that can pass through the locking hole during surgery, causing surgical delays. No patient injuries have been reported.

    Product
    A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1240-2025·2025-03-05

    MRI System May Resume Scanning Above Safe Thermal Limits

    GE Healthcare's Brivo MR355 MRI system can incorrectly resume scans when tissue heating limits are exceeded, potentially causing thermal burns if patients contact conductive materials. The recall affects 22 systems distributed nationwide and internationally.

    Product
    Brivo MR355, NMRI system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2025·2025-03-05

    Socrates 38 Aspiration Catheter Recall Due to Sterile Barrier Defect

    Scientia Vascular is recalling 120 Socrates 38 Aspiration Catheters due to manufacturing defects that created channels in the packaging seal. The defect could potentially compromise the sterile barrier on devices used for acute stroke treatment.

    Product
    Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1238-2025·2025-03-05

    Pentax EPK-i8020c Video Processor Recalled for Thermal Burn Risk

    Pentax EPK-i8020c video processors can overheat during endoscopic procedures, creating a risk of thermal burns to patient tissues. The light guide tip becomes hot and may cause injury to mucous membranes.

    Product
    Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V141000·2025-03-04

    2025 Triumph Speed Twin Motorcycles Recalled for Turn Signal Visibility Defect

    Triumph is recalling 2025 Speed Twin motorcycles (900, 1200, 1200 RS) due to red rear turn signals installed too close to the tail light, reducing visibility and increasing crash risk. Dealers will replace the signals with amber colored ones free of charge.

    Product
    TRIUMPH — TRIUMPH SPEED TWIN 900, SPEED TWIN 1200 RS, SPEED TWIN 1200
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V140000·2025-03-04

    Jayco Recalls 2025 Eagle Trailers Due to Incorrect Tire Certification Labels

    Jayco is recalling 2025 Eagle fifth wheels and travel trailers because certification labels contain incorrect tire load and size information.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER, JAYCO FIFTH WHEEL EAGLE HT, EAGLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V137000·2025-03-03

    Motiv Recalls Chassis Vehicles Due to Throttle Position Sensor Defect

    Motiv Power Systems is recalling specific chassis vehicles because a loose throttle position sensor pin may cause a loss of drive power, increasing crash risk.

    Product
    MOTIV — MOTIV F-53 BEV CHASSIS, F-53 CHASSIS, F-59 BEV CHASSIS, E-450 BEV CHASSIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V136000·2025-02-28

    Big Tex Recalls 2025 Trailers Due to Undersized Winch Hardware

    Big Tex Trailer Manufacturing is recalling 2025 14RB, 14RD, 16RB, and 16RD trailers because undersized winch hardware may allow the winch to detach, creating a road hazard.

    Product
    BIG TEX — BIG TEX 16RD, 14RB, 16RB, 14RD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V124000·2025-02-28

    Ford Maverick brake lights can illuminate without the driver braking

    Ford is recalling certain 2022 Maverick vehicles previously repaired under 24V-730, because the ABS module may illuminate the brake lights when the driver is not braking. This fails FMVSS 108.

    Product
    FORD — FORD MAVERICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V134000·2025-02-28

    Ford Super Duty rearview image may not show with hitch assist

    Ford is recalling certain 2023 F-Super Duty F-250, F-350 and F-450 vehicles previously repaired under 23V-573, because the default rearview camera image may not display when using Pro Trailer Hitch Assist.

    Product
    FORD — FORD F-350 SD, F-250 SD, F-450 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V123000·2025-02-28

    Ford Maverick Hybrid instrument cluster may not illuminate warning lights

    Ford is recalling certain 2022-2023 Maverick Hybrid vehicles previously repaired under 24V-140, because the instrument panel cluster may not properly illuminate warning lights or gauges.

    Product
    FORD — FORD MAVERICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25156·2025-02-27

    Canyon Speedmax CF Triathlon Bicycles Recalled for Fork Cracking Hazard

    Canyon Bicycles USA recalls about 1,400 Speedmax CF triathlon bicycles due to fork steerer tubes that can crack or break, creating a fall hazard. The company is offering free repairs at authorized service centers.

    Product
    Canyon Speedmax CF Triathlon Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·25V122000·2025-02-27

    Orange EV Recalls HUSK-E Trucks Due to Incorrect Weight Rating Placard

    Orange EV is recalling 2023-2024 HUSK-E XP terminal trucks because the rear weight rating placard is incorrect and tires may be inadequate, increasing crash risk.

    Product
    ORANGE EV — ORANGE EV HUSK-E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25161·2025-02-27

    P.J. Salvage Children's Pajama Sets and Robes Recalled for Flammability Violation

    P.J. Salvage recalled approximately 9,400 children's pajama sets and robes sold at Nordstrom Rack because they violate federal flammability regulations, posing a risk of burn injuries to children. No injuries have been reported.

    Product
    P.J. Salvage Pajama Sets and Robes
    Category
    Consumer Product
    Distribution
    Distributed nationwide