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.

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2426–2450 of 13381

  • HighFDA (Devices)·Z-2472-2025·2025-09-03

    American Contract Systems Surgical Kits Recalled Due to Unconfirmed Sterilization

    American Contract Systems is recalling 588 surgical procedure kits distributed in Illinois and Louisiana due to inability to confirm proper sterilization of certain components. The kits may not meet sterilization assurance requirements.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUM
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2469-2025·2025-09-03

    Obstetric procedure kits recalled due to unconfirmed sterilization assurance

    American Contract Systems is recalling 781 medical procedure kits because the manufacturer cannot confirm sterilization was properly completed. The affected kits were distributed to healthcare facilities in Illinois and Louisiana.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2473-2025·2025-09-03

    STA Satellite Analyzer Recalled for Potential Reagent Contamination

    Diagnostica Stago recalls STA Satellite analyzers due to potential contamination of STA-LIQUID ANTI-Xa reagent by Stago Fibrinogen reagents in heparin applications. The contamination could affect the accuracy of coagulation test results.

    Product
    STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2452-2025·2025-09-03

    Medline General Surgery Tray kits recalled for tourniquet cuff weld defect

    Medline is recalling surgical tray kits containing Stryker tourniquet cuffs that may fail due to a manufacturing defect at the weld, risking patient hemorrhaging.

    Product
    The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits will be assembled using
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2465-2025·2025-09-03

    American Contract Systems Medical Procedure Kits Recalled Due to Sterilization Assurance Failure

    American Contract Systems is recalling 1,233 medical procedure kits distributed in Illinois and Louisiana because the company cannot confirm sterilization requirements were met for certain components.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2418-2025·2025-09-03

    THOR NovoTHOR Gen 3.0 Light Therapy Device Canopy Failure

    THOR Photomedicine recalls the NovoTHOR Gen 3.0 light therapy device due to faulty welded nuts that can shear off, detaching the gas strut and making the canopy difficult to lift.

    Product
    Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2440-2025·2025-09-03

    Orascoptic Custom Surgical Loupes Recalled for Potential Nickel Allergy Reactions

    Orascoptic custom surgical loupes are being recalled because their nose pads contain nickel, which may cause allergic reactions in people with nickel sensitivity.

    Product
    Orascoptic Superior Visualization Custom loupes with Dragonfly frames
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2476-2025·2025-09-03

    Fibrinogen diagnostic kit contamination risk in heparin applications

    Diagnostica Stago is recalling STA-Fibrinogen 5 diagnostic kits due to potential contamination that could affect anticoagulation monitoring tests in patients receiving heparin therapy.

    Product
    STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2462-2025·2025-09-03

    Foley Catheter Lumen Obstruction Recall — Potential Urinary Drainage Failure

    Bardex Foley catheters manufactured by C.R. Bard may develop obstructed lumens that prevent urine drainage, potentially causing kidney injury and pain. The recall affects 175,158 units distributed across specific U.S. states and Japan.

    Product
    Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2466-2025·2025-09-03

    Medical procedure kits recalled due to unconfirmed sterilization

    American Contract Systems is recalling 1,127 medical procedure kits distributed to Illinois and Louisiana because the manufacturer cannot confirm sterilization requirements were met for certain components.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SA
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2424-2025·2025-09-03

    Onkos Surgical Recalls ELEOS Segmental Limb Salvage System Implants

    Onkos Surgical is recalling ELEOS Segmental Limb Salvage System canal filling stem implants due to an unidentified substance discovered during a retrospective evaluation. No injuries have been reported.

    Product
    ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2471-2025·2025-09-03

    Surgical procedure kits recalled due to sterilization assurance concerns

    American Contract Systems Inc is recalling hysterectomy procedure kits from IL and LA due to inability to confirm sterilization assurance requirements were met.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2408-2025·2025-09-03

    Philips X5-1 Transducer Probe Recalled for Useful Life Labeling Clarification

    Philips is recalling X5-1 Transducer Probes to clarify labeling regarding the product's useful life. The manufacturer is providing updated labeling to clearly define when the device should no longer be used.

    Product
    X5-1 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2411-2025·2025-09-03

    Philips X7-2 Transducer Probes Recalled for Useful Life Labeling Clarification

    Philips Ultrasound is recalling approximately 171,322 X7-2 Transducer Probes distributed nationwide to provide clarification and labeling regarding the useful life of these ultrasound devices.

    Product
    X7-2 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2437-2025·2025-09-03

    Hemodialysis delivery system may trigger false alarms causing repeated priming cycles

    The PrisMax V2-US hemodialysis delivery system may produce false air-detection alarms during priming due to low deaeration chamber levels, resulting in multiple unnecessary priming cycles.

    Product
    PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2393-2025·2025-09-03

    Philips S4-2 Transducer Probe Labeling Clarification on Useful Life

    Philips is clarifying labeling on S4-2 Transducer Probes to define product useful life. About 171,322 units distributed nationwide are affected.

    Product
    S4-2 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2451-2025·2025-09-03

    Intraocular lenses with incorrect power recalled for vision impairment risk

    Bausch & Lomb is recalling Akreos intraocular lenses due to a manufacturing error that resulted in incorrect lens power (16 diopters instead of 3), which could cause vision problems requiring optical or surgical correction.

    Product
    Akreos, SKU: AO60P0300. Akreos intraocular lenses
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2386-2025·2025-09-03

    Philips Ultrasound mL26-8 Transducer Probe Labeling Clarification Recall

    Philips Ultrasound is recalling 171,322 mL26-8 Transducer Probe units nationwide to provide clarification and labeling defining the useful life of these ultrasound transducers in clinical use.

    Product
    mL26-8 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2356-2025·2025-09-03

    Philips C6-3 Transducer Probe Labeling Clarification on Useful Life

    Philips is providing labeling clarification to define the useful life of C6-3 Transducer Probes in the field. 171,322 units are affected nationwide.

    Product
    C6-3 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2366-2025·2025-09-03

    Philips D2cwc Transducer Probes recalled for labeling clarification

    Philips Ultrasound recalls 171,322 D2cwc Transducer Probes nationwide to provide clarification labeling on device useful life. Facilities should review updated labeling for proper device management and replacement schedules.

    Product
    D2cwc Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2402-2025·2025-09-03

    Philips Ultrasound L12-5 Transducer Probe Recall for Labeling Clarification

    Philips is recalling 171,322 L12-5 ultrasound transducer probes distributed nationwide to provide clarification and proper labeling defining the device's useful life.

    Product
    TRANSDUCER L12-5 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide