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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23976–24000 of 40299

  • HighFDA (Devices)·Z-1633-2018·2018-05-16

    Vygon Recalls PICC Insertion Kits Due to Sterility Risk

    Vygon U.S.A. is recalling 16,520 PICC Kit units (Product Code AMS-7063-1) because potential friction holes may compromise product sterility.

    Product
    PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1754-2018·2018-05-16

    Cook Inc. Recalls Connecting Tubes Due to Potential Leakage

    Cook Inc. is recalling 304 connecting tubes because the cap-adapter assembly may not tighten adequately, potentially causing fluid leakage or air aspiration.

    Product
    Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1777-2018·2018-05-16

    Parker Laboratories Recalls Sterile Ultrasound Gel for Potential Seal Leaks

    Parker Laboratories, Inc. is recalling Sterile Aquasonic 100 Ultrasound Transmission Gel because the packet seals may leak.

    Product
    Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1670-2018·2018-05-16

    Siemens Dimension Sirolimus Reagent Cartridge Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling Dimension Sirolimus reagent cartridges because biotin can interfere with test results, potentially affecting patient care.

    Product
    Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1669-2018·2018-05-16

    Siemens Dimension Free Thyroxine Reagent Cartridge Recall for Labeling Error

    Siemens is recalling Dimension Free Thyroxine reagent cartridges because the instructions for use incorrectly state the level at which biotin does not interfere.

    Product
    Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1658-2018·2018-05-16

    Siemens Dimension Vista Glucose Assay Recalled for Drug Interference

    Siemens is recalling Dimension Vista Glucose assays because they may produce inaccurate results when used with certain drugs.

    Product
    Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1668-2018·2018-05-16

    Siemens Recalls Dimension TSHL Reagent Cartridges Due to Biotin Labeling Error

    Siemens Healthcare Diagnostics is recalling Dimension TSHL reagent cartridges because the instructions for use incorrectly state the biotin concentration level at which interference does not occur.

    Product
    Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1646-2018·2018-05-16

    Siemens ADVIA Ammonia Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Ammonia assays because sulfasalazine and sulfapyridine may cause inaccurate test results.

    Product
    ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1765-2018·2018-05-16

    Bard POWERPORT ClearVUE Slim Catheter Recalled for Incorrect Patient ID Card Instructions

    Bard Peripheral Vascular Inc is recalling 383 units of POWERPORT ClearVUE Slim catheters because the packaged Patient ID Card contains incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1801-2018·2018-05-16

    Beaver-Visitec Recalls Hemostatic Eraser Bipolar Due to Incorrect Labeling

    Beaver-Visitec International Inc. is recalling 1,025 units of Wet-Field Hemostatic Eraser Bipolar 25G instruments because they were packaged with incorrect labeling.

    Product
    Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1759-2018·2018-05-16

    Synthes Sciatic Nerve Retractor Recalled for Potential Microspore Formation

    Synthes (USA) Products LLC is recalling 196 Sciatic Nerve Retractors due to a potential for microspores to form on the hollow handle, which could allow fluid entry.

    Product
    Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1772-2018·2018-05-16

    Bard POWERPORT ClearVUE Implantable Port Recall for Incorrect Instructions

    Bard Peripheral Vascular Inc is recalling 15 units of POWERPORT ClearVUE isp Implantable Port kits because the included Patient ID Card contains incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1654-2018·2018-05-16

    Siemens Dimension Thyroxine Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Thyroxine assays because they may produce inaccurate results when used with certain drugs.

    Product
    Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1689-2018·2018-05-16

    Siemens ADVIA Centaur Folate Recalled for Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate assays because biotin interference levels are not listed in the instructions, potentially affecting test accuracy.

    Product
    ADVIA Centaur¿ Folate (FOL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1778-2018·2018-05-16

    Siemens Syngo.Via Software Recall for Report Functionality Defect

    Siemens Medical Solutions is recalling Syngo.Via VB20A software because corrected report values are not saved or transmitted, causing the system to use original values.

    Product
    Syngo.Via VB20A model 1049610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1768-2018·2018-05-16

    Bard POWERPORT ClearVUE Slim Catheter Recalled for Incorrect Flushing Instructions

    Bard Peripheral Vascular Inc is recalling 3,196 units of POWERPORT ClearVUE Slim catheters because the included Patient ID Card contains incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1742-2018·2018-05-16

    Hyphen BioMed Recalls ZYMUTEST HIA MonoStrip IgG Assay Kits

    Hyphen BioMed is recalling 12 ZYMUTEST HIA MonoStrip IgG kits because the package insert incorrectly lists serum and other fluids as valid sample types.

    Product
    ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1764-2018·2018-05-16

    Bard POWERPORT ClearVUE Slim Catheter Recalled for Incorrect Patient Card Instructions

    Bard Peripheral Vascular Inc is recalling POWERPORT ClearVUE Slim catheters because the included Patient ID Card contains incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1676-2018·2018-05-16

    Siemens IMMULITE 2000 Folic Acid Assay Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Folic Acid assays because biotin interference is not listed in the instructions for use.

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1653-2018·2018-05-16

    Siemens Creatine Kinase MB Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling the Dimension Creatine Kinase MB (MBI) assay because it may produce inaccurate results when used with certain drugs.

    Product
    Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1678-2018·2018-05-16

    Siemens IMMULITE CEA Assay Recalled for Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling IMMULITE CEA assays because biotin interference thresholds are not listed in the instructions, potentially affecting test accuracy.

    Product
    IMMULITE ¿ /IMMULITE ¿ 1000 CEA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1693-2018·2018-05-16

    Straumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Changes

    Straumann Manufacturing is recalling Emdogain Enamel Matrix Derivative because a raw material shelf life change was implemented without submitting data to demonstrate continued product efficacy.

    Product
    Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1649-2018·2018-05-16

    Siemens Dimension Ammonia Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Ammonia assays because they may produce inaccurate results when used with certain drugs.

    Product
    Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1779-2018·2018-05-16

    MHC Medical Recalls EasyTouch Insulin Syringes Due to Lot Labeling Error

    MHC Medical Products LLC is recalling EasyTouch Insulin Syringes because retail cartons may display incorrect lot numbers.

    Product
    EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1643-2018·2018-05-16

    Beckman Coulter iChemVELOCITY Urine Chemistry System Recall for Incorrect Settings

    Beckman Coulter is recalling 2,225 iChemVELOCITY Urine Chemistry Systems because incorrect settings may cause false low results or incorrect color reporting.

    Product
    BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700- 7176-001, 700-7177-001 Product Usage: The iChemVELOCITY…
    Category
    Medical Device
    Distribution
    Distributed nationwide