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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22876–22900 of 40299

  • HighFDA (Devices)·Z-2803-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and manifold.

    Product
    18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2805-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2823-2018·2018-08-22

    Merit Medical Recalls Pediatric Peritoneal Dialysis Catheters Due to Mix-Up

    Merit Medical Systems is recalling specific lots of Flex-Neck Classic Peritoneal Dialysis Catheters (Pediatric) due to a mix-up with adult catheters.

    Product
    Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck¿ PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2821-2018·2018-08-22

    Zimmer Biomet Recalls Echo Hip Stems Due to Potential Component Comingle

    Zimmer Biomet is recalling 12 Echo Bi-Metric Hip Stems because they may have been mixed with a different model. The error could extend surgery time.

    Product
    ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2820-2018·2018-08-22

    Zimmer Biomet Recalls ARCOS Modular Revision Hip System Femoral Stems

    Zimmer Biomet is recalling 12 ARCOS Modular Revision Hip System femoral stems because they may have been mixed with Echo BI-Metric stems, potentially extending surgery time.

    Product
    ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2743-2018·2018-08-22

    Apollo Lap-Band System Recalled Due to Missing Component

    Apollo Endosurgery Inc. is recalling 54 units of the Apollo Lap-Band AP System Small with RapidPort EZ because a component was missing from the package.

    Product
    Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with pillows that are filled with saline and a buckle that joins the ends of the bands together, an access port and silicone tubing that connects the band to the…
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2751-2018·2018-08-22

    Terumo CDI System 500 Monitor Recalled for H/Sat Module Self-Test Failure

    Terumo is recalling 128 CDI System 500 monitors because a subset of devices fail the automated H/Sat Color Chip Test. This failure disables the H/Sat module but does not cause device inaccuracy.

    Product
    Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2818-2018·2018-08-22

    Arrow Hands-Off Central Venous Catheter Recalled for Packaging Seal Defects

    Arrow International Inc. is recalling 7,024 units of Hands-Off Multi-Lumen Central Venous Catheters because packaging may not be sealed, potentially compromising sterility.

    Product
    HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2835-2018·2018-08-22

    Intuitive Surgical Recalls da Vinci Xi Endoscope Controller for Calibration Defect

    Intuitive Surgical is recalling one da Vinci Xi Endoscope Controller due to improper calibration. The defect may cause dim images, color imbalance, or increased fogging.

    Product
    The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2750-2018·2018-08-22

    Terumo CDI Blood Parameter Monitoring System 500 H/SAT Recalled for Self-Test Failures

    Terumo is recalling 128 CDI Blood Parameter Monitoring System 500 H/SAT units because a hybrid intensity shift causes the automated Color Chip Test to fail, disabling the H/Sat module.

    Product
    CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2748-2018·2018-08-22

    Siemens ARTIS Pheno X-Ray System Recalled for Potential Hardware Thermal Issue

    Siemens Medical Solutions USA is recalling 605 ARTIS Pheno interventional fluoroscopic X-ray systems due to a potential hardware issue that may cause thermal effects and damage to system parts.

    Product
    ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2742-2018·2018-08-22

    Merit Medical Systems Recalls 1mL Medallion Syringes Due to Plunger Defect

    Merit Medical Systems is recalling 22,234 units of 1mL Medallion Syringes due to a manufacturing defect in the plunger tip.

    Product
    1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2836-2018·2018-08-22

    DRG Instruments Recalls Salivary Estradiol ELISA Kits Due to Measurement Errors

    DRG Instruments GmbH is recalling 169 Salivary Estradiol ELISA kits because poor differentiation between standards may cause lower recovery of estradiol levels.

    Product
    Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2822-2018·2018-08-22

    Nico Corp. Recalls Mislabeled Sterile Shepherd's Hook Accessories

    Nico Corp. is recalling 204 sterile Shepherd's Hook accessories because they were shipped with incorrect transport labels instead of product labels.

    Product
    NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2749-2018·2018-08-22

    Richard-Allan Scientific Recalls Mislabeled EZ Single Cytofunnel Brown Units

    Richard-Allan Scientific is recalling 1,039 cases of EZ Single Cytofunnel Brown units due to mislabeling. The recall is voluntary and nationwide.

    Product
    EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific Cytospin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2786-2018·2018-08-22

    Clarity 10SG Urinalysis Strips Recalled for Analyzer Incompatibility

    Clarity Diagnostics is recalling specific lots of Clarity 10SG Urinalysis Strips because they lack a Canister Code Bar Code Label, making them incompatible with Clarity Urocheck 120 Urine Analyzers.

    Product
    Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2827-2018·2018-08-22

    Tosoh Bioscience Recalls AIA Analyte Application Manual CDs

    Tosoh Bioscience is recalling 9 AIA Analyte Application Manual CDs due to unapproved product labeling. The CDs were distributed to six US states.

    Product
    Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference…
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2553-2018·2018-08-15

    Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Airflow Obstruction Risk

    Vyaire Medical is recalling 15,714 pediatric AirLife Resuscitation Devices because a manufacturing error may obstruct supplemental oxygen airflow during use.

    Product
    AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve, Part Number 2K8008; c. Pediatric…
    Category
    Medical Device
    Distribution
    28 states
  • SevereFDA (Devices)·Z-2681-2018·2018-08-15

    Howmedica Recalls rHead Stem Implant 6mm Collar Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 245 rHead Stem Implant 6mm Collar units because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Stem Implant 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2675-2018·2018-08-15

    Howmedica Recalls Stryker Radial Head Implant Assemblies Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 191 Stryker rHead Radial Head implant assemblies because literature reviews indicate a higher revision rate than other similar devices.

    Product
    Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2712-2018·2018-08-15

    Howmedica Recalls #3 Bipolar Radial Head Implant Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 999 units of the #3 Bipolar radial head implant because literature reviews indicate a higher revision rate than other similar devices.

    Product
    #3 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2716-2018·2018-08-15

    Howmedica Recalls Stryker rHead Radial Head Orthopedic Implants

    Howmedica Osteonics Corp. is recalling 543 units of the #2 Bipolar stem implant from the Stryker rHead system due to higher-than-expected revision rates.

    Product
    #2 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2736-2018·2018-08-15

    FDA Recalls iTOVi Tracker/Scanner Devices Due to Shock Complaints

    Hudson Scientific LLC is recalling iTOVi Tracker/Scanner devices because they may not meet manufacturing standards and have caused electric shocks.

    Product
    iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to generate a report that then makes a recommendation on nutritional supplements.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2660-2018·2018-08-15

    Arjohuntleigh Magog Quick Connect 272 KG Scale Recall for Detachment Risk

    Arjohuntleigh Magog is recalling Quick Connect 272 KG Scales used with Maxi Sky 2 ceiling lifts because the spreader bar can detach from the scale attachment.

    Product
    Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient lifters to measure the weight of a patient who cannot stand on a scale. It is designed to be used indoors in hospitals, nursing homes, home care or health care…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2577-2018·2018-08-15

    Qiagen AmniSure ROM Test Recalled for Potential Control Line Failure

    Qiagen Sciences is recalling 1,620 AmniSure ROM Test kits because the control line may not appear on the test strip, potentially affecting result validity.

    Product
    AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.
    Category
    Medical Device
    Distribution
    Distributed nationwide