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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23901–23925 of 40175

  • 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
  • ModerateFDA (Devices)·Z-1767-2018·2018-05-16

    Bard Peripheral Vascular Recalls POWERPORT ClearVUE Catheters

    Bard Peripheral Vascular Inc is recalling 4,044 POWERPORT ClearVUE catheters because the Patient ID Card contains incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1674-2018·2018-05-16

    Siemens IMMULITE 2000 Allergy IgE Kit Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Allergy specific IgE Universal Kits because biotin interference is not documented in the instructions for use.

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 3g Allergy specific IgE Universal Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1659-2018·2018-05-16

    Siemens Creatine Kinase MB Assay Recalled for Drug Interference

    Siemens is recalling the Dimension Vista Creatine Kinase MB assay because it may produce inaccurate results when used with certain drugs.

    Product
    Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1763-2018·2018-05-16

    Bard POWERPORT ClearVUE Slim Catheter Recalled for Incorrect Patient Card Instructions

    Bard Peripheral Vascular Inc is recalling 216 units of POWERPORT ClearVUE Slim catheters because the packaged Patient ID Card contains incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1651-2018·2018-05-16

    Siemens Dimension AST Assay Recalled for Drug Interference

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

    Product
    Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1686-2018·2018-05-16

    Siemens IMMULITE Vitamin B12 Assay Recalled Due to Biotin Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE Vitamin B12 assays because biotin interference is not listed in the instructions for use.

    Product
    IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1782-2018·2018-05-16

    Ondamed Biofeedback Device Recalled for Lack of Marketing Clearance

    Ondamed Inc is recalling 585 Ondamed Biofeedback Devices because they were marketed in the US without FDA clearance. Customers are advised to contact the firm for an available upgrade.

    Product
    Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1682-2018·2018-05-16

    Siemens IMMULITE CA125 Assay Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE CA125 assays because biotin interference thresholds are not listed in the instructions, potentially affecting test accuracy.

    Product
    IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)
    Category
    Medical Device
    Distribution
    Distributed nationwide