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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3876–3900 of 13543

  • 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
    0 states
  • 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-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-1081-2025·2025-02-12

    Philips AlluraXper FD20 Biplane Patient Table Finger Entrapment Risk

    Philips AlluraXper FD20 Biplane patient tables may cause finger entrapment between the tabletop and guiding rails during manual repositioning, affecting operators and service personnel.

    Product
    AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1092-2025·2025-02-12

    Philips Azurion patient tables recalled for finger entrapment hazard

    Philips is recalling Azurion 7 B20 patient tables due to a finger entrapment hazard between the tabletop and guiding rails during manual repositioning. Operators and service personnel could suffer finger injury.

    Product
    Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
    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
    0 states
  • 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-1091-2025·2025-02-12

    Philips Azurion and Allura System Patient Tables: Finger Entrapment Risk

    Philips Azurion and Allura system patient tables may trap fingers between the guiding rails and tabletop during manual repositioning, risking finger injury to operators and service personnel.

    Product
    Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1099-2025·2025-02-12

    Belmont Medical 3-Spike Disposable Set May Leak During Use

    The Belmont Medical 3-Spike Disposable Set may leak during priming due to a crack in its female quick connector, potentially delaying warmed infusions in hospital settings.

    Product
    Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids to any patients e10 kg requiring warmed infusion. Part Number:903-00006
    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
  • HighFDA (Devices)·Z-1086-2025·2025-02-12

    Philips AD7 and AD7X Patient Table Finger Entrapment Risk

    The Philips AD7 and AD7X patient tables pose a finger entrapment risk during manual repositioning. Operators and service personnel could sustain finger injuries from the gap between the longitudinal guiding rails and tabletop.

    Product
    AlluraXperFD20/15 System Code: (1) 722058
    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-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-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-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-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-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
    0 states
  • HighFDA (Devices)·Z-1077-2025·2025-02-12

    Philips AD7 and AD7X patient tables recalled due to finger entrapment risk

    Philips has recalled the AD7 and AD7X patient tables used in medical imaging systems because fingers can become entrapped between the tabletop and guiding rails during manual repositioning, potentially causing injury.

    Product
    Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1075-2025·2025-02-12

    Levofloxacin Antimicrobial Susceptibility Discs Recalled Due to Packaging Mislabeling

    Oxoid Limited is recalling 1,406 units of Lev5 Levofloxacin susceptibility discs because packaging may contain Norfloxacin discs instead, which could affect laboratory test results.

    Product
    Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1093-2025·2025-02-12

    Philips Azurion patient tables recalled for finger entrapment risk

    Philips is recalling Azurion 7 M12 and Allura patient tables used in medical imaging systems due to a finger entrapment hazard during manual repositioning. Operators and service personnel may suffer finger injury if fingers are caught between the tabletop and guiding rails.

    Product
    Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233
    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-1097-2025·2025-02-12

    PERMA-HAND Silk Sutures Recalled for Packaging Sterility Breach

    Ethicon is recalling PERMA-HAND Silk Sutures that may have open seals on packaging due to manufacturing defects, risking sterility compromise and patient infection. Approximately 78,792 units were distributed nationwide and internationally.

    Product
    PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk 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-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