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.

5151–5175 of 52958

  • HighFDA (Devices)·Z-1215-2025·2025-03-05

    Anatomic Lateral Fibula Plate locking screw malfunction during surgery

    Tyber Medical is recalling 220 A.L.P.S. mvX Anatomic Lateral Fibula Plates due to complaints that the locking screw passes through the locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fibula Plate, 10-Hole, Left. Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770708101
    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-1236-2025·2025-03-05

    Video Colonoscope May Cause Thermal Burns to Tissue During Use

    The PENTAX Medical Video Colonoscope (Model EC38-i20cL) can develop excessive heat at the tip during procedures, potentially causing thermal burns to patient tissue. Users reported dark images and steam-like smoke from the device.

    Product
    PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1242-2025·2025-03-05

    MRI Systems May Resume Scans When SAR Exceeds Safe Limits

    Certain GE Healthcare MRI systems may incorrectly enable scan resumption when radiofrequency energy absorption exceeds FDA-set limits, potentially causing tissue heating. Risk is higher for patients with implants or touching conductive materials.

    Product
    SIGNA MR355, SIGNA MR360, NMRI system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2025·2025-03-05

    Clinical Chemistry Analyzer Fails to Track Assay Expiration Dates After Software Update

    A software issue in the DxC 500 AU analyzer prevents correct tracking of assay expiration dates after software upgrades. Expired assays may be used, potentially producing inaccurate patient test results.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
    Category
    Medical Device
    Distribution
    19 states
  • 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 (Devices)·Z-1221-2025·2025-03-05

    Medial Tibia Plate Recall: Locking Screw Defect During Surgery

    Tyber Medical is recalling A.L.P.S. mvX Medial Tibia Plates because the locking screw may not properly secure during surgery, causing surgical delays. No injuries have been reported.

    Product
    A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770715101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1247-2025·2025-03-05

    Leica Biosystems Cryostat CM1950 Firmware Update May Cause Tissue Loss

    A software issue in the Leica Biosystems CM1950 cryostat firmware update could result in loss of patient tissue. Serial numbers 12835 and 12854 are affected.

    Product
    Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1231-2025·2025-03-05

    Infusion Pump Manual Instructs Users to Leave Safety Clamp Open

    BD Alaris Pump Module user manual incorrectly instructs users to leave the safety clamp open when reloading infusion sets, potentially causing accidental over-infusion.

    Product
    BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administra
    Category
    Medical Device
    Distribution
    51 states
  • 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
  • HighFDA (Devices)·Z-1219-2025·2025-03-05

    Orthopedic tibia plate locking screw failure causes surgical delays

    Tyber Medical recalls A.L.P.S. mvX Medial Tibia plates; the locking screw can pass through the locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715061
    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-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
  • HighNHTSA·25V144000·2025-03-05

    Mercedes-Benz Tourrider Buses Recalled for Missing Driver Seat Bracket

    Daimler Coaches is recalling 2022-2025 Mercedes-Benz Tourrider buses because a missing driver's seat bracket may allow the backrest to fold forward in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ TOURRIDER PREMIUM, TOURRIDER BUSINESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V142000·2025-03-05

    Blue Arc BA4L-800 Recalled for Headlight Adjustment Defect

    Shyft Group is recalling 2024-2025 Blue Arc BA4L-800 vehicles because missing headlight covers allow beam adjustment, potentially causing glare or reduced visibility.

    Product
    BLUE ARC — BLUE ARC BA4L-800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2025·2025-03-05

    Plato 17 Microcatheter Recall Due to Sterile Barrier Packaging Defect

    Scientia Vascular is recalling Plato 17 Microcatheter units due to manufacturing defects in the packaging seal that could compromise sterility during vascular procedures.

    Product
    Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interventional or diagnostic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0574-2025·2025-03-05

    Beverage Base Lemonade Recalled for Undeclared Yellow #5

    OCBW INC is recalling Beverage Base Lemonade products due to undeclared Yellow #5. A total of 8,847 units were distributed across eight states. Consumers with sensitivities to food dyes should not consume the product.

    Product
    Beverage Base Lemonade, 3 gallon, BIB: Best By 12/12/2025; Beverage Base Lemonade, 5 gallon, BIB: Best By 01/12/2026
    Category
    Food
    Distribution
    8 states
  • 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 (Food)·F-0575-2025·2025-03-05

    Beverage Base Recalled for Undeclared Yellow #5 Allergen

    OCBW INC is recalling Beverage Base Sweet&Sour in 3-gallon bulk containers due to undeclared Yellow #5, a color additive. The product was distributed across eight states and poses a risk to consumers with sensitivities to this ingredient.

    Product
    Beverage Base Sweet&Sour, 3 gallon, BIB: Best By 12/10/2025
    Category
    Food
    Distribution
    8 states
  • HighFDA (Drugs)·D-0248-2025·2025-03-05

    Avastin intravitreal injection syringes recalled for sterility assurance failure

    Turbare Manufacturing recalls 1,147 syringes of Avastin 1.25 mg intravitreal injection nationwide due to a quality control process deviation affecting sterility assurance.

    Product
    Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01.
    Category
    Drug
    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-1230-2025·2025-03-05

    BD Pyxis MedBank medication cabinets recalled for operating room contraindication labeling

    CareFusion is recalling BD Pyxis MedBank medication management cabinets due to inadequate labeling. A contraindication statement must be added to warn against use in procedure and operating rooms.

    Product
    139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2HH-1FM MEDPASS 169-150 BD PYXIS MEDBANK MINI 4HH MEDPASS 169-140 BD PYXIS MEDBANK TWR MN 3FH-8HH MEDPASS
    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-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