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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3826–3850 of 13449

  • HighFDA (Devices)·Z-1094-2025·2025-02-12

    Philips Azurion and Allura Patient Table Finger Entrapment Risk

    Philips Azurion 7 M20 and Allura patient tables pose a finger entrapment risk during manual repositioning. Fingers can get caught between the tabletop and guiding rails, potentially causing finger injury to operators and service personnel.

    Product
    Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1114-2025·2025-02-12

    Endodontic Files Recalled for Excess Irradiation Causing Package Integrity Issues

    US Endodontics is recalling endodontic files due to irradiation above specification, which may compromise package integrity. The recall affects 789,729 devices distributed in the US and internationally.

    Product
    Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK AP135253PK AP135313PK AP145213PK AP145253PK AP145313PK AP1GP213PK AP1GP253PK AP1GP313PK O.U.S. Products: EdgeFile X7 REF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2025·2025-02-12

    Philips AlluraXper Operating Room Table Finger Entrapment Hazard

    The Philips AlluraXper FD20 operating room table can trap fingers between the guiding rails and tabletop during manual repositioning, potentially injuring operators and service personnel.

    Product
    AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
    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-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-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-1045-2025·2025-02-12

    GE Discovery XR656 HD X-ray system AEC control malfunctions during imaging

    GE Medical Systems is recalling the Discovery XR656 HD X-ray imaging system due to a malfunction in the Automatic Exposure Control (AEC) feature. The defect allows continued X-ray exposure beyond intended limits without requiring operator acknowledgment.

    Product
    Discovery XR656 HD. X-Ray imaging system.
    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-1111-2025·2025-02-12

    Temporary Titanium Abutments May Fracture in Dental Implants

    DDS Lab temporary titanium abutments may have been installed in some dental implant restoration cases instead of definitive abutments. The components may fracture, risking restoration loosening, oral tissue injury, and aspiration.

    Product
    Temporary Titanium Abutments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-1044-2025·2025-02-12

    Medical X-Ray System Permits Bypass of Radiation Exposure Control

    GE Medical Systems' Discovery XR656HD X-Ray imaging systems can allow radiation exposures to exceed the Automatic Exposure Control limit without blocking further exposure. Approximately 3,149 units are affected worldwide, including 1,697 in the United States.

    Product
    Discovery XR656HD. X-Ray imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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-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-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-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-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-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-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-1090-2025·2025-02-12

    Philips Azurion 5 M20 Patient Tables Recalled for Finger Entrapment Hazard

    Philips Azurion 5 M20 x-ray system patient tables can trap fingers between the tabletop and guiding rails during repositioning. The hazard may cause finger injury to operators and service personnel.

    Product
    Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1104-2025·2025-02-12

    Integra Miltex Cryosolutions Cartridges Recalled for Premature Valve Opening

    The Integra Miltex Cryosolutions Cartridges (Model C-CA-23) are being recalled because the valve may open prematurely during assembly, causing the cartridge to empty before use. Approximately 3,352 units were distributed nationwide in the US and Canada.

    Product
    Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1103-2025·2025-02-12

    Nitrous Oxide Cartridges Recalled Due to Premature Valve Opening

    Integra Miltex CryoSolutions N2O cartridges are recalled because the valve may open prematurely, causing partial or complete cartridge emptying before use. Affected units were distributed nationwide and to Canada.

    Product
    Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
    Category
    Medical Device
    Distribution
    Distributed nationwide