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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4501–4525 of 39968

  • 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-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-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 (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-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-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-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-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-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-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
  • 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-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-1243-2025·2025-03-05

    GE SIGNA MR380 NMRI System SAR Limit Exceeded During Scan Resumption

    GE SIGNA MR380 NMRI systems may allow scans to resume when the 6-minute average SAR (tissue heating rate) exceeds safe limits, potentially causing excessive tissue heating especially in patients with implants or conductive contact.

    Product
    SIGNA MR380, NMRI system, Non-US Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1227-2025·2025-03-05

    BD PYXIS MEDBANK systems operating room contraindication labeling update

    BD PYXIS MEDBANK medication management systems are subject to a labeling update adding a contraindication against use in procedure and operating rooms. Approximately 6,075 units were distributed nationwide.

    Product
    138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P 139002-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P 139000-01 BD PYXIS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1248-2025·2025-03-05

    Medical device recall: sterilization validator with incorrect incubation time

    TERRAGENE S.A. is recalling 914 ASP BIOTRACE Auto Read 60 sterilization process challenge devices due to incorrect incubation time listed in the product instructions. The IFU lists 20 minutes instead of the correct 60 minutes.

    Product
    ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1229-2025·2025-03-05

    BD PYXIS medication cabinets labeling update: operating room contraindication

    CareFusion is updating labeling for BD PYXIS medication management cabinets to add a contraindication statement prohibiting use in procedure and operating rooms.

    Product
    139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEX MN 1000 2HH-5FM 139038-01 BD PYXIS MEDFLEX MN 1000 3FM 139040-01 BD PYXIS MEDFL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1228-2025·2025-03-05

    BD PYXIS MEDBANK Medication Systems: Labeling Update for Operating Room Restriction

    CareFusion is updating labeling for BD PYXIS MEDBANK medication systems to include a contraindication against use in procedure and operating rooms. Healthcare facilities should review updated labeling and ensure appropriate device placement.

    Product
    155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 138921-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 155159-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 169-101 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 139122-01 BD PYXIS MEDBANK MINI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1144-2025·2025-02-26

    Allura Xper FD20 Fluoroscopy Table Mattress Issue Causes Fall Risk

    Philips recalls Allura Xper FD20 fluoroscopy patient tables due to a mattress issue that may cause patients to fall during procedures.

    Product
    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1152-2025·2025-02-26

    Philips Allura Xper Patient Table Mattress Defect Fall Risk

    Philips is recalling the Allura Xper FD10C patient examination table due to a mattress defect that may allow patients to fall from the table. The device was distributed worldwide.

    Product
    Allura Xper FD10C; Catalog number: 722001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1070-2025·2025-02-26

    Vascular Tack Endovascular System recalled for deployment and migration risks

    Spectranetics' Intact Vascular Tack Endovascular System may fail to deploy properly or migrate in blood vessels, potentially causing ischemia and requiring additional intervention.

    Product
    Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm, REF: 15613
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1161-2025·2025-02-26

    Philips Allura Centron patient table mattress defect poses fall risk

    Philips is recalling Allura Centron patient examination tables due to a mattress defect that poses a fall risk. Eighty units have been distributed internationally.

    Product
    Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1148-2025·2025-02-26

    Philips Allura Xper FD20/10 Imaging System Patient Table Mattress Fall Risk

    Philips is recalling the Allura Xper FD20/10 imaging system due to a defect in the patient table mattress that could allow patients to fall during procedures. The Class I recall affects 87 units distributed globally, including 22 in the US.

    Product
    Allura Xper FD20/10; Catalog numbers: 722029
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1151-2025·2025-02-26

    Philips Allura CV20 Patient Table: Fall Risk from Mattress Defect

    Philips is recalling the Allura CV20 patient table due to a mattress defect that could allow patients to fall. The recall affects 111 units distributed worldwide.

    Product
    Allura CV20; Catalog numbers: 722031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1154-2025·2025-02-26

    Philips Azurion 3 M15 Patient Tables Recalled for Patient Fall Risk

    Philips recalls Azurion 3 M15 imaging tables due to mattress defects that could cause patients to fall from the examination table.

    Product
    Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
    Category
    Medical Device
    Distribution
    Distributed nationwide