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.

8076–8100 of 22104

  • HighFDA (Devices)·Z-1218-2025·2025-03-05

    Orthopedic Fixation Plates Recalled for Screw Locking Failure During Surgery

    Tyber Medical is recalling 115 A.L.P.S. mvX orthopedic plates because the locking screw can pass through the locking hole during surgery, causing surgical delays and inadequate fracture fixation.

    Product
    A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right. Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708122 Product Description:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1216-2025·2025-03-05

    Anatomic lateral fibula plate locking screw failure during surgery

    Tyber Medical A.L.P.S. mvX anatomic lateral fibula plates (219 units nationwide) have a defect where the locking screw can pass through its locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole, Right. Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770708102 Product Description:
    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
  • HighFDA (Food)·F-0581-2025·2025-03-05

    Rajbhog Sweets Jelebi Orange Recalled for Undeclared Milk Allergen

    Rajbhog Sweets Jelebi Orange is being recalled due to undeclared milk. Consumers with milk allergies should not consume this product.

    Product
    Rajbhog Sweets Jelebi Orange, 9.5 oz packages and sold by weight from bulk trays.
    Category
    Food
    Distribution
    0 states
  • 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-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
    0 states
  • HighFDA (Devices)·Z-1206-2025·2025-03-05

    BD Pyxis Medication Dispensing Devices Labeling Update Addresses Manual Access Risk

    FDA is requiring labeling updates for BD Pyxis automated medication dispensing devices to address the risk of delays in medication access due to power loss or device malfunctions. The recall affects approximately 1,521 units distributed nationwide.

    Product
    BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.
    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 (Food)·F-0573-2025·2025-03-05

    Idaho Pacific Potato Flour Recalled for Undeclared Milk Allergen

    Idaho Pacific Fine Potato Flour has been recalled due to undeclared milk content (13-17 ppm) not listed on the label. Consumers with milk allergies should not consume this product.

    Product
    Idaho Pacific Fine Potato Flour, product #20501, packaged in multi-walled Kraft bag, Net Wt. 50lbs. No UPC code. Manufactured by Idaho Pacific Corporation, Ririe, ID 83443.
    Category
    Food
    Distribution
    3 states
  • 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-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-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 (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-1209-2025·2025-03-05

    Anatomic Lateral Fibula Plate recalled for locking screw malfunction

    Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates due to reports of locking screws passing through the locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1213-2025·2025-03-05

    Orthopedic plate recall: locking screw may pass through hole during surgery

    Tyber Medical is recalling 214 units of A.L.P.S. mvX orthopedic plates (nationwide) because the locking screw may pass through the locking hole during surgery. Surgical delays have been reported.

    Product
    A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended to bridge or otherwise stabilize bone fragments to facilitate healing. Model/Catalog Number: 770708081
    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
    0 states
  • 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-1226-2025·2025-03-05

    Medial Tibia Plate Recall Due to Locking Screw Malfunction During Surgery

    Tyber Medical recalls 109 units of the A.L.P.S. mvX Medial Tibia Plate nationwide due to reports of the locking screw passing through the locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770715162
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V339000·2025-03-05

    Multiple travel trailers recalled for detaching freshwater tanks

    Forest River travel trailers may have freshwater tanks that detach when full, posing a road hazard. Dealers will install additional attachment straps at no cost.

    Product
    CLIPPER TOWABLE — 2021 CLIPPER TOWABLE CWT272RLS
    Category
    Vehicle
    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-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 (Food)·F-0580-2025·2025-03-05

    Chocolate Caramels recalled for contamination with plastic pieces

    V Chocolates, Inc is recalling Assorted Chocolate Caramels with kosher sea salt due to plastic pieces from a broken tray. Consumers should not consume this product and should dispose of or return it.

    Product
    Assorted Chocolate Caramels with kosher sea salt, Net Weight 1.25lb
    Category
    Food
    Distribution
    Distributed nationwide
  • 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-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-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