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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18101–18125 of 27534

  • HighFDA (Devices)·Z-1737-2018·2018-05-16

    Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Error

    Zimmer Biomet is recalling 54 Gentle Threads Interference Screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, increasing infection risk.

    Product
    Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the ankle/foot and knee.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1572-2018·2018-05-16

    Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 720 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1796-2018·2018-05-16

    Siemens Recalls Dimension Lipase Flex Reagent Cartridge Lot FB8109

    Siemens Healthcare Diagnostics is recalling one lot of Dimension Lipase Flex Reagent Cartridges due to calibration failure causing positive bias in test results.

    Product
    Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1694-2018·2018-05-16

    Straumann Emdogain Recall Due to Shelf Life Data Issue

    Straumann Manufacturing is recalling specific lots of Emdogain because a raw material shelf life change was made without data proving the product remains effective.

    Product
    Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1789-2018·2018-05-16

    TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances

    TP Orthodontics is recalling 7 Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.

    Product
    Jasper Vektor, Class II Correction Appliance, Part No. 610-530L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-1672-2018·2018-05-16

    Siemens Recalls Dimension Vista MMB Reagent Cartridges Due to Biotin Interference

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridges because the instructions for use do not list the biotin concentration that causes interference.

    Product
    Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1798-2018·2018-05-16

    Inpeco Laboratory Automation Systems Recalled for Module Freezing Risk

    Inpeco S.A. is recalling 18 laboratory automation systems because a module may freeze without warning, potentially delaying patient test results.

    Product
    FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1575-2018·2018-05-16

    Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 270 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.

    Product
    AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1732-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Seal Separation Risk

    Datascope Corporation is recalling four custom tubing kits because a seal defect may allow air to enter the housing, potentially collapsing the balloon and reducing blood flow.

    Product
    BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1687-2018·2018-05-16

    Siemens Recalls ADVIA Centaur Cyclosporine Due to Labeling Error

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Cyclosporine because the instructions for use incorrectly state the biotin non-interference level.

    Product
    ADVIA Centaur¿ Cyclosporine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1558-2018·2018-05-16

    Vyaire Medical Recalls AirLife Pediatric Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 42 AirLife Pediatric Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.

    Product
    AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1634-2018·2018-05-16

    Vygon Recalls Neonatal PICC Trays Due to Potential Sterility Issues

    Vygon U.S.A. is recalling 16,520 Neonatal PICC Trays because potential friction holes may affect the product's sterility.

    Product
    Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2018·2018-05-16

    Cook Inc. Recalls Connecting Tubes Due to Potential Leakage

    Cook Inc. is recalling 220 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.

    Product
    Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-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-1555-2018·2018-05-16

    Vyaire Medical Recalls AirLife Pediatric Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 24 AirLife Pediatric Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1663-2018·2018-05-16

    Baxter Sigma Spectrum Infusion Pump Recalled for Documentation Errors

    Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because technicians omitted required safety tests, potentially compromising air and occlusion detection.

    Product
    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2018·2018-05-16

    Bard BrachySource Iodine-125 Radioactive Seeds Recalled for Dosage Mix-Up

    Bard Brachytherapy is recalling Iodine-125 radioactive seeds because incorrect dosage levels were mixed up and sent to two hospitals in California and Georgia.

    Product
    BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1762-2018·2018-05-16

    Bard Peripheral Vascular Recalls POWERPORT ClearVUE Catheters Due to Incorrect Instructions

    Bard Peripheral Vascular Inc is recalling 1551 units of the POWERPORT ClearVUE Slim catheter because the included Patient ID Card has incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1560-2018·2018-05-16

    Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 4,640 AirLife Infant Resuscitation Devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.

    Product
    AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1664-2018·2018-05-16

    Baxter Sigma Spectrum Infusion Pump Recall Due to Testing Documentation Errors

    Baxter is recalling 444 Sigma Spectrum Infusion Pumps because technicians omitted specific safety tests. The missing tests for air and occlusion detection could lead to serious health consequences.

    Product
    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1783-2018·2018-05-16

    TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances

    TP Orthodontics is recalling 108 Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.

    Product
    Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-1770-2018·2018-05-16

    Bard Peripheral Vascular Recalls POWERPORT ClearVUE Catheters Due to Incorrect Instructions

    Bard Peripheral Vascular Inc is recalling specific lots of POWERPORT ClearVUE catheters because the included Patient ID Card has incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1563-2018·2018-05-16

    Vyaire Medical Recalls AirLife Pediatric Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 2,340 AirLife Pediatric Resuscitation Devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.

    Product
    AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1684-2018·2018-05-16

    Siemens Recalls Immulite Assays Due to Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling certain IMMULITE assays because the instructions for use do not list the biotin concentration that causes interference, posing a risk of inaccurate test results.

    Product
    IMMULITE ¿ /IMMULITE ¿ 1000 TG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1200-2018·2018-05-16

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for ECG Signal Interference

    Siemens is recalling 229 ACUSON SC2000 ultrasound systems because electromagnetic interference from electrosurgical equipment may cause the ECG signal to flatline.

    Product
    ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1637-2018·2018-05-16

    Vygon Recalls PICC Trays Due to Potential Sterility Compromise

    Vygon U.S.A. is recalling 16,520 PICC Trays because potential friction holes may affect the sterility of the product.

    Product
    PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide