The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

3676–3700 of 13449

  • 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-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-1239-2025·2025-03-05

    MRI Systems Allow Unsafe Scan Resumption Exceeding SAR Safety Limits

    GE Healthcare MRI systems may incorrectly resume scans after power loss when tissue heating rates exceed safe limits, risking excessive heating if patients contact conductive materials or have implants.

    Product
    SIGNA Creator, SIGNA Explorer, NMRI systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1212-2025·2025-03-05

    A.L.P.S. mvX Fibula Plate Recall: Locking Screw Malfunction During Surgery

    Tyber Medical is recalling 408 units of the A.L.P.S. mvX Anatomic Lateral Fibula Plate because the locking screw can pass through the locking hole during surgery, causing surgical delays. No injuries have been reported.

    Product
    A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole, Right Model/Catalog Number: 770708062
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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 (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-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-1214-2025·2025-03-05

    Orthopedic Surgical Plates Recalled Due to Intra-Operative Locking Screw Malfunction

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

    Product
    A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right Indicated for use in Fixation of fractures of the distal tibia Model/Catalog Number: 77070802
    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-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-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 (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 (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-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-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-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-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-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-1222-2025·2025-03-05

    Orthopedic Tibia Plate Locking Screw Malfunction Nationwide Recall

    Tyber Medical is recalling 209 A.L.P.S. mvX Medial Tibia plates nationwide due to reports that locking screws can pass through the locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended Fixation of fractures of the distal tibia. Model/Catalog Number: 770715102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2025·2025-03-05

    LIFEPAK 20e Defibrillator Recalled for Incorrect Keypad Installation

    Physio-Control is recalling LIFEPAK 20e defibrillator/monitor units distributed in West Virginia due to incorrect keypad installation during manufacturing. The keypad error may affect device operation.

    Product
    LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
    Category
    Medical Device
    Distribution
    1 state