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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3201–3225 of 27346

  • HighFDA (Devices)·Z-1102-2025·2025-02-12

    ECG cable shipped with incomplete cleaning and disinfection instructions

    Physio-Control is recalling 245 LIFEPAK 35 ECG cables (Lot 0224) because the shipped instructions do not include proper cleaning and disinfection procedures, creating potential cross-contamination risks.

    Product
    LIFEPAK 35 ECG cable REF 11111-000041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1073-2025·2025-02-12

    VNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect

    LivaNova's SenTiva VNS generators (48 units) may stop delivering stimulation due to a mechanical defect. Patients may experience return to baseline seizure or depressive symptoms and may require replacement surgery.

    Product
    SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1113-2025·2025-02-12

    Sysmex PS-10 Sample Preparation System Recalled for False Test Results

    Sysmex PS-10 Sample Preparation Systems may produce false test results due to sporadic omission of the probe wash step during antibody pipetting. Thirty-two units have been recalled nationwide.

    Product
    Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1046-2025·2025-02-12

    X-Ray Imaging System May Continue Exposure Beyond Safety Limit

    GE Medical Systems' Optima XR646 HD X-Ray imaging systems may allow continued radiation exposure beyond the safety limit without operator confirmation. A warning message displays but does not prevent the excess exposure.

    Product
    Optima XR646 HD. X-Ray imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1107-2025·2025-02-12

    Patient Monitor May Fail to Alarm on Ventilator Disconnect

    Philips IntelliVue Patient Monitor MX400 may fail to alarm when a Hamilton ventilator is disconnected. 28 units affected in the US and internationally.

    Product
    IntelliVue Patient Monitor MX400. Model Number: 866060
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1082-2025·2025-02-12

    Philips AlluraXper FD20 operating room surgical table finger entrapment risk

    Philips AlluraXper FD20 operating room tables can trap fingers during manual repositioning, risking injury. The hazard affects both operators and service personnel worldwide.

    Product
    AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1115-2025·2025-02-12

    Beckman Coulter DxI 9000 immunoassay analyzer recalled for software-related motion errors

    Beckman Coulter is recalling 61 DxI 9000 immunoassay analyzers worldwide due to a software error causing tray gripper motion errors that result in intermittent hard stops and delays in patient test results.

    Product
    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1108-2025·2025-02-12

    Patient Monitor May Fail to Alert When Ventilator Disconnects

    Philips IntelliVue Patient Monitor MX450 units may fail to sound an alarm when a Hamilton ventilator becomes disconnected, potentially delaying detection of the disconnection.

    Product
    IntelliVue Patient Monitor MX450. Model Number: 866062
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1110-2025·2025-02-12

    IntelliVue Patient Monitor MX550 May Fail to Alarm on Ventilator Disconnection

    Philips IntelliVue Patient Monitor MX550 units may fail to generate an alarm when a Hamilton ventilator is disconnected, creating a patient safety risk. The monitor could remain silent without alerting clinical staff.

    Product
    IntelliVue Patient Monitor MX550. Model Number: 866066
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1118-2025·2025-02-12

    Spine Surgery Planning Software Calculation Errors in Rod Planning Parameters

    Medicrea International is recalling UNiD Spine Analyzer software due to calculation errors in rod planning parameters. The software experienced anomalies resulting in incorrect values for surgical classification and measurement parameters used in spine surgery planning.

    Product
    UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a he
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1109-2025·2025-02-12

    IntelliVue Patient Monitor MX500 may fail to generate critical alarms

    Philips IntelliVue Patient Monitor MX500 units may fail to generate "No Device Data" alarms when a Hamilton ventilator disconnects, potentially delaying notification of loss of connectivity. 45 units distributed in the US and internationally.

    Product
    IntelliVue Patient Monitor MX500. Model Number: 866064
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1085-2025·2025-02-12

    Finger entrapment hazard in Philips Allura fluoroscopy patient tables

    Philips is recalling AD7 and AD7X patient tables from Allura and Azurion fluoroscopy systems. During manual repositioning, fingers can become trapped between the guiding rails and tabletop, potentially causing injury.

    Product
    Allura Xper FD20/20 System Code: (1) 722038
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1043-2025·2025-02-12

    X-Ray imaging systems may allow radiation exposure beyond safety limits

    GE Medical Systems is recalling Definium 656HD and Discovery XR656HD X-Ray systems due to an Automatic Exposure Control defect that may allow radiation exposure to exceed intended safety limits.

    Product
    Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1096-2025·2025-02-12

    FDA Recalls PROLENE Polypropylene Sutures for Defective Packaging Seals

    Ethicon is recalling PROLENE polypropylene sutures because some packages have open seals due to a manufacturing defect. Defective seals may allow pathogens to contaminate the sterile sutures, potentially causing infection.

    Product
    PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1076-2025·2025-02-12

    Philips Allura CV20 patient tables risk finger entrapment during repositioning

    The Philips Allura CV20 System patient tables (AD7 and AD7X models) pose a finger entrapment hazard during manual repositioning. Fingers can become caught between the tabletop and guiding rails, potentially injuring operators and service personnel.

    Product
    Allura CV20 System Code: 722031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1084-2025·2025-02-12

    Philips Allura and Azurion Patient Tables Recall Due to Finger Entrapment Risk

    Philips is recalling AD7 and AD7X patient tables used in Allura and Azurion medical imaging systems due to a finger entrapment hazard during manual repositioning. Operators and service personnel are at risk of finger injury.

    Product
    AlluraXperFD20/10 System Code: (1) 722029
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1105-2025·2025-02-12

    NeiMed NasoGel nasal spray recalled due to stability failure

    Neilmed Pharmaceuticals is recalling NasoGel for Dry Noses due to stability failure that may allow microbial growth. The product was distributed across 30 U.S. states and to five countries.

    Product
    NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1080-2025·2025-02-12

    Philips recalls AlluraXper FD20 patient tables due to finger entrapment hazard

    Philips is recalling AlluraXper FD20 patient tables due to a finger entrapment hazard. During manual repositioning, fingers can get trapped between the tabletop and rails, risking injury to operators and service personnel.

    Product
    AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2025·2025-02-12

    VNS Therapy Generators May Stop Delivering Stimulation Due to Component Failure

    The SenTiva and SenTiva Duo vagus nerve stimulation generators may stop delivering therapy due to an internal mechanical component becoming stuck, causing potential loss of seizure and depression control.

    Product
    SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1106-2025·2025-02-12

    IntelliBridge EC10 Module may fail to alarm on ventilator disconnection

    The IntelliBridge EC10 Module may fail to sound an alarm when a Hamilton ventilator is disconnected. This could allow unnoticed disconnections that could affect patient monitoring.

    Product
    IntelliBridge EC10 Module. Model Number: 865115
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1047-2025·2025-02-12

    Newborn Resuscitator Kit Recalled for Inline Spring Defect

    414 newborn resuscitator kits (ROi CPS LLC) recalled for a potential spring defect in the Inline Controller that could prevent proper ventilation pressure in labor and delivery settings.

    Product
    regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1078-2025·2025-02-12

    Philips AlluraXper Patient Tables Pose Finger Entrapment Risk

    Philips is recalling AD7 and AD7X patient tables used in Allura and Azurion fluoroscopy systems. Manual repositioning can trap fingers between the tabletop and rails, risking injury to operators and service personnel.

    Product
    AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1098-2025·2025-02-12

    Surgical sutures recalled for potential sterility breach

    Ethicon is recalling ETHIBOND EXCEL Polyester Sutures due to open packaging seals that could compromise sterility and allow pathogen contamination. No illnesses have been reported.

    Product
    ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1079-2025·2025-02-12

    Philips Allura patient tables recall due to finger entrapment risk

    Philips recalls AD7 and AD7X patient tables in Allura and Azurion systems due to finger entrapment risk during manual repositioning. Operators and service personnel could suffer finger injuries.

    Product
    Allura Xper FD10C System Code: (1) 722001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1088-2025·2025-02-12

    Philips Azurion Patient Tables Recalled for Finger Entrapment Risk

    Philips Azurion patient tables used in medical imaging systems can trap fingers between the tabletop and rails during manual repositioning, potentially causing finger injury to operators and service personnel.

    Product
    Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280
    Category
    Medical Device
    Distribution
    Distributed nationwide