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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4476–4500 of 39987

  • 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-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-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-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-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-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-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-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-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
  • 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
  • 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-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-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
  • 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-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-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-1147-2025·2025-02-26

    Operating room table recalled due to mattress-related patient fall risk

    Philips Allura Xper FD20 OR Table units (catalog numbers 722023, 722035) are recalled due to a mattress defect that could cause patients to fall during procedures.

    Product
    Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1153-2025·2025-02-26

    Philips Azurion 3 M12 Medical Table Recalled for Patient Fall Risk

    Philips is recalling Azurion 3 M12 patient tables due to possibility of patient falling from the table related to the mattress. The recall affects 263 units distributed in the US and internationally.

    Product
    Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1157-2025·2025-02-26

    Philips Azurion 7 B12 examination tables recalled due to patient fall risk

    Philips Medical Systems is recalling Azurion 7 B12 examination tables due to a mattress-related patient fall risk. The recall affects 602 total units, including 94 in the US and 508 internationally.

    Product
    Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1143-2025·2025-02-26

    Philips Allura Xper Fluoroscopy Device Patient Table Mattress Fall Risk

    Philips Medical is recalling certain Allura Xper FD10/10 fluoroscopy systems because the patient table mattress could cause patients to fall during procedures. The recall affects devices worldwide.

    Product
    Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1158-2025·2025-02-26

    Philips Azurion 7 B20 imaging system patient fall hazard from table mattress

    Philips Azurion 7 B20 imaging systems are recalled because the patient table mattress may allow patients to fall. This FDA Class I recall affects 1,314 units distributed worldwide.

    Product
    Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1146-2025·2025-02-26

    Surgical Operating Table Recalled Due to Patient Fall Risk

    Philips Medical Systems is recalling the Allura Xper FD20 Biplane OR Table due to a mattress defect that could cause patients to fall during surgery. 3 units are affected globally.

    Product
    Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1156-2025·2025-02-26

    Philips Azurion 5 M20 tables recalled due to patient fall risk

    Philips is recalling Azurion 5 M20 imaging tables worldwide due to a mattress defect that could cause patients to fall from the table. This FDA Class I recall involves 632 units.

    Product
    Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1142-2025·2025-02-26

    Medical imaging device patient table mattress may cause patient falls

    Philips is recalling Allura Xper FD10 imaging devices because the patient table mattress may not securely hold patients during procedures, creating a fall hazard. The recall affects 2,274 units worldwide, including 459 in the U.S.

    Product
    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
    Category
    Medical Device
    Distribution
    Distributed nationwide