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.

Filters

Agency

Category

Minimum severity

Clear filters

33226–33250 of 40449

  • HighFDA (Devices)·Z-1476-2015·2015-04-29

    Churchill Medical Systems Recalls Bifurcated Sets Due to Leaking Risk

    Churchill Medical Systems is recalling 1,050 bifurcated sets with check valves and Bionectors due to a potential for leaking caused by insufficient bonding.

    Product
    Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1482-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Spec Failures

    Wright Medical Technology is recalling 51 units of the Crosscheck Plating System because dimensional specifications are out of range, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Left, REF CCP-HSX1L. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1468-2015·2015-04-29

    Churchill Medical Systems Recalls Bifurcated Extension Sets Due to Leaking Risk

    Churchill Medical Systems is recalling 100 Bifurcated Extension Sets because a defect may cause leaking. The sets are used to administer medical fluids.

    Product
    Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1458-2015·2015-04-29

    Spacelabs Pediatric Flow Sensor Kit Recalled for Inaccurate Low Flow Readings

    Del Mar Reynolds Medical is recalling Spacelabs Pediatric Flow Sensor Kits because they report inspiratory and expiratory tidal volumes lower than the actual volumes delivered to patients.

    Product
    Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1463-2015·2015-04-29

    Thermedx Fluid Management System P4000 Recalled for Software Bugs

    Thermedx LLC is recalling 127 Fluid Management System P4000 units due to software bugs that could affect the accuracy of fluid deficit measurements.

    Product
    Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic procedures.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1493-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Specification Defects

    Wright Medical Technology is recalling 172 units of the Crosscheck Plating System because specific dimensions are out of specification, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1469-2015·2015-04-29

    Churchill Medical Systems Recalls 4-inch Microbore Double Lumen Sets

    Churchill Medical Systems is recalling 2,350 units of 4-inch Microbore Double Lumen Sets due to a potential leak caused by an insufficient bond between the needleless device and the female luer.

    Product
    4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1483-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Dimensional Defects

    Wright Medical Technology is recalling 52 units of the Crosscheck Plating System because dimensional specifications are out of range, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right, REF CCP-HSX1R. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1473-2015·2015-04-29

    Churchill Medical Systems Recalls 7-Inch High Pressure Sets Due to Leaking Risk

    Churchill Medical Systems is recalling 129,500 units of 7-inch High Pressure Sets with Bionector due to a potential for leaking caused by insufficient bonding.

    Product
    7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1486-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Dimensional Defects

    Wright Medical Technology is recalling 102 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1499-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Specification Defects

    Wright Medical Technology is recalling 151 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, Utility Plate, 7-Hole, REF CCP-UTN7. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1455-2015·2015-04-29

    DBX Mix Bone Void Filler Recalled for Potential Packaging Seal Defect

    Musculoskeletal Transplant Foundation is recalling 25 units of DBX Mix bone void filler because the outer packaging seal may not be fully intact.

    Product
    DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1510-2015·2015-04-29

    Specialty Appliance Works Recalls Universal Nuts for Incorrect Stainless Steel Material

    Specialty Appliance Works is recalling Universal Nuts used in Herbst Appliances because they were made with 416 SS instead of the specified 303 SS.

    Product
    Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1459-2015·2015-04-29

    Exactech Recalls Equinoxe 44mm Short Humeral Head Shoulder Implants

    Exactech, Inc. is recalling 112 Equinoxe 44mm Short Humeral Head shoulder implant components because incorrect outer and inner labeling may misidentify the device size.

    Product
    Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1501-2015·2015-04-29

    SenTec Recalls V-Sign Sensor 2 Due to Premature PCO2 Unit Deterioration

    SenTec AG is voluntarily replacing V-Sign Sensor 2 units because a part of the PCO2 measuring unit deteriorates prematurely, disabling PCO2 monitoring. The recall affects 129 units in the US and 59 outside the US.

    Product
    Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. The SenTec Digital Monitoring System (SDMS) is used for continuous and non-invasive monitoring of transcutaneous carbon dioxide tension (tcPCO2), oxygen…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1454-2015·2015-04-29

    Focus Diagnostics Recalls Stratify JCV DxSelect Assay Due to False Positive Risk

    Focus Diagnostics is recalling 300 units of the Stratify JCV DxSelect assay (Lot 27333) because a non-conforming batch may cause false positive results.

    Product
    STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1516-2015·2015-04-29

    PhotoMedex Recalls Iamin Medical Devices Due to Inconsistent Labeling

    PhotoMedex, Inc. is recalling Iamin Moist Dressings and Hydrating Gel because their labeling does not match the intended uses approved by the FDA.

    Product
    Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1503-2015·2015-04-29

    Specialty Appliance Works Recalls Orthodontic Universal Nuts Due to Material Error

    Specialty Appliance Works is recalling 14,428 Universal Nuts used in orthodontic Herbst Appliances because they were manufactured with 416 SS instead of the specified 303 SS.

    Product
    MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1512-2015·2015-04-29

    Xpress System Pedicle Screw Assembly Recalled for Incorrect Laser Marking

    X Spine Systems Inc is recalling 14 units of Xpress System Pedicle Screw Assemblies because the laser marking on the yoke incorrectly states 7.5 x 55mm instead of 5.5 x 55mm.

    Product
    Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1509-2015·2015-04-29

    Specialty Appliance Works Recalls Orthodontic Universal Nut Components

    Specialty Appliance Works is recalling Universal Nut components for Herbst Appliances because they were made with 416 SS instead of the specified 303 SS.

    Product
    TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/pk), TS Crown Component 5LR (5/pk), TS Crown Component 6LR (5/pk), TS Crown Component 4UL (5/pk), TS Crown Component 5UL (5/pk), TS Crown Component 4LL (5/pk)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1466-2015·2015-04-29

    Biomet Recalls Torque Limiting Handles for Spinal Fixation Devices

    Biomet Spine is recalling 874 Torque Limiting Handles used in spinal fixation due to supplier component updates.

    Product
    Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1505-2015·2015-04-29

    Specialty Appliance Works Recalls MiniScope Mechanical Set Universal Nuts

    Specialty Appliance Works is recalling Universal Nuts for MiniScope Mechanical Sets because they were made with 416 stainless steel instead of the specified 303 stainless steel.

    Product
    Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and Specialty MiniScope Mech. Set Size 24 A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1502-2015·2015-04-29

    Herbst Universal Nut Recalled for Incorrect Stainless Steel Material

    Specialty Appliance Works is recalling Herbst Universal Nuts because they were manufactured with 416 SS instead of the specified 303 SS.

    Product
    Herbst Universal Nut which is used in a Herbst Appliance A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1504-2015·2015-04-29

    Specialty Appliance Works Recalls Orthodontic Herbst Appliance Nuts

    Specialty Appliance Works is recalling TS Herbst Nuts because they were manufactured with 416 stainless steel instead of the specified 303 stainless steel.

    Product
    TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1511-2015·2015-04-29

    Specialty Appliance Works Recalls Orthodontic Universal Nut Components

    Specialty Appliance Works is recalling TS ROC Crown Components because the Universal Nut was made with 416 SS instead of the specified 303 SS.

    Product
    TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk)…
    Category
    Medical Device
    Distribution
    Distributed nationwide