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 the agency’s own highest classification or reported deaths or serious injuries, 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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25276–25300 of 40233

  • ModerateFDA (Devices)·Z-0300-2018·2018-01-10

    Zimmer Biomet Recalls ECHO POR FMRL NC 9X125 Due to Labeling Error

    Zimmer Biomet is recalling ECHO POR FMRL NC 9X125 medical devices because the internal patient label may be incorrect, although the outer box and product are correctly identified.

    Product
    ECHO POR FMRL NC 9X125, model # 192009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0305-2018·2018-01-10

    Zimmer Biomet Recalls Distal Femoral Knee Implant Due to Labeling Error

    Zimmer Biomet is recalling a specific lot of distal femoral knee implant assemblies because the internal patient label may be incorrect, although the product itself is correctly identified.

    Product
    RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0296-2018·2018-01-10

    Zimmer Biomet Recalls Lateral Troch Plate Due to Labeling Error

    Zimmer Biomet is recalling Lateral Troch Plate Full Crimp units because the internal patient label may be incorrect, though the product itself is correct.

    Product
    Lateral Troch Plate Full Crimp - 254mm, model # 350837
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0314-2018·2018-01-10

    Smiths Medical Medfusion Syringe Infusion Pump Recall for Clamp Loosening

    Smiths Medical is recalling Medfusion Syringe Infusion Pumps because a loose clamp mechanism may cause the device to incorrectly alarm for invalid syringe sizes.

    Product
    Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0301-2018·2018-01-10

    Zimmer Biomet Recalls CER OPTION TYPE 1 TPR SLEVE -6 Due to Labeling Error

    Zimmer Biomet is recalling CER OPTION TYPE 1 TPR SLEVE -6 devices because the internal patient label may be incorrect, although the outer box and product are correctly identified.

    Product
    CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0306-2018·2018-01-10

    Euro Diagnostica Recalls DIASTAT ANA ELISA Kits Due to Performance Deviation

    Euro Diagnostica is recalling 534 DIASTAT ANA ELISA kits (Lot TS 2076) distributed in Minnesota, Nebraska, and Texas because a component deviation may cause false positive results.

    Product
    Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0297-2018·2018-01-10

    Zimmer Biomet Recalls Lateral Troch Plate Due to Labeling Error

    Zimmer Biomet is recalling Lateral Troch Plate Full Crimp devices because the internal patient label may be incorrect, although the outer box and product are correctly identified.

    Product
    Lateral Troch Plate Full Crimp - 254mm, model # 350838
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0299-2018·2018-01-10

    Zimmer Biomet Recalls COMP Primary Stem Due to Labeling Error

    Zimmer Biomet is recalling COMP Primary Stem 8MM MINI devices because the internal patient label may be incorrect, although the product itself is correctly identified.

    Product
    COMP PRIMARY STEM 8MM MINI, model # 113628
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0312-2018·2018-01-10

    Zimmer Biomet Recalls PPS RingLoc+ Acetabular Shells Due to Missing Etching

    Zimmer Biomet is recalling 15 units of PPS RingLoc+ Acetabular Shells because the product was distributed with missing etching.

    Product
    PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc¿+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. The Porous Plasma Spray (PPS) Ringloc¿+…
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-0308-2018·2018-01-10

    Beckman Coulter Access 2 Immunoassay System Recalled for Burn Risk

    Beckman Coulter is recalling Access 2 Immunoassay Systems due to a potential for minor skin burns if the tool contacts the reagent storage interface board during pipettor alignment.

    Product
    Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0310-2018·2018-01-10

    Beckman Coulter Recalls UniCel DxC 600i Systems Due to Burn Risk

    Beckman Coulter is recalling two UniCel DxC 600i SYNCHRON Access Clinical Systems because a tool may contact a board and cause minor skin burns during alignment.

    Product
    UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0309-2018·2018-01-10

    Beckman Coulter Access 2 Immunoassay System Recalled for Burn Risk

    Beckman Coulter is recalling three Access 2 Immunoassay Systems due to a potential risk of minor skin burns during pipettor alignment.

    Product
    Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0213-2018·2018-01-03

    Sterilmed recalls reprocessed St. Jude Medical Agilis NxT Steerable Introducers

    Sterilmed Inc is recalling 112 reprocessed St. Jude Medical Agilis NxT Steerable Introducers due to inadequate seals caused by missing adhesive glue.

    Product
    St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0289-2018·2018-01-03

    Accuray TomoHDA System Recalled for Uncontrolled Couch Movement

    Accuray is recalling 87 TomoHDA radiation therapy systems worldwide due to a defect causing uncontrolled couch descent.

    Product
    TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0288-2018·2018-01-03

    Accuray TomoH System Recalled for Uncontrolled Couch Movement

    Accuray is recalling 29 TomoH Systems due to a defect causing uncontrolled couch descent, posing a risk of injury to patients.

    Product
    TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0286-2018·2018-01-03

    Accuray Hi-Art System Recalled for Uncontrolled Couch Movement

    Accuray Incorporated is recalling 250 Hi-Art(R) Systems due to uncontrolled couch Z-axis movement (descent). The affected units are distributed worldwide.

    Product
    Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0270-2018·2018-01-03

    L3 Security Cabinet X-ray System Recalled for Shielding Gaps

    L3 Security & Detection is recalling 471 Examiner 3DX 6000 cabinet X-ray systems used for airline baggage screening due to shielding gaps that may cause excessive X-ray emissions.

    Product
    L3 Security & Detection System Cabinet X-ray system used for security screening of checked airline baggage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0287-2018·2018-01-03

    Accuray TomoHD System Recalled for Uncontrolled Couch Movement

    Accuray is recalling 118 TomoHD radiation therapy systems worldwide due to uncontrolled couch descent.

    Product
    TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0292-2018·2018-01-03

    Philips IntelliVue Patient Monitors Recalled for Distorted ST-Segment Display

    Philips is recalling specific IntelliVue patient monitors and measurement servers because they may display distorted ST-segments during 12-lead ECG monitoring.

    Product
    IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0295-2018·2018-01-03

    Medline Recalls Sterile Elastic Esmark Bandages Due to Sterilization Failure

    Medline Industries is recalling 5,722 units of sterile elastic bandages because they may not have been properly sterilized.

    Product
    Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into a corrugate case, 20 individually packed bandages per case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2018·2018-01-03

    Orthofix Power Drill Torque Limiter Recalled Due to Breakage Risk

    Orthofix Srl is recalling 416 units of Power Drill Torque Limiters because they may break during surgical use. The devices are used for temporary bone stabilization in lower limb procedures.

    Product
    Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0273-2018·2018-01-03

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products PHYT Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides because they may produce biased results when used with citrate plasma specimens.

    Product
    VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0290-2018·2018-01-03

    Remel Shigella sonnei Agglutinating Serum Recalled for Failure to Agglutinate

    Remel Inc is recalling Shigella sonnei Agglutinating Serum because it may fail to agglutinate within the specified minimum reaction time.

    Product
    Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0285-2018·2018-01-03

    Randox HbA1c Reagent Recalled for Low Calibration Absorbance

    Randox Laboratories is recalling 90 kits of HbA1c reagent (Batch 414553) due to low calibration absorbance that may affect performance.

    Product
    Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0264-2018·2017-12-27

    BioMerieux Recalls ETEST Oxacillin Strips Due to Quality Control Failures

    BioMerieux SA is recalling ETEST Oxacillin strips due to quality control failures that may cause false resistant results.

    Product
    ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
    Category
    Medical Device
    Distribution
    Distributed nationwide