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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23501–23525 of 40299

  • SevereFDA (Devices)·Z-2126-2018·2018-06-13

    Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating Systems and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.

    Product
    CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Large (002-G-01030)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2131-2018·2018-06-13

    Orthofix Recalls MTP Plates Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling specific MTP plates because locking screws failed to properly engage during surgery.

    Product
    MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Large (002-B-03003)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2132-2018·2018-06-13

    Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure

    Orthofix is voluntarily recalling Rival Reduce Fracture Plating and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.

    Product
    Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001); b) 4 Hole (003-D-02001); c) 6 Hole (003-D-03001)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2135-2018·2018-06-13

    Orthofix Recalls Rival Plating Systems Due to Screw Engagement Failure

    Orthofix is voluntarily recalling Rival Reduce Fracture and View Plating Systems because locking screws failed to engage plates during surgery.

    Product
    Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2134-2018·2018-06-13

    Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating Systems and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.

    Product
    T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-02001)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2121-2018·2018-06-13

    Orthofix Recalls Non-Locking Screws for Improper Plate Engagement

    Orthofix, Inc. is voluntarily recalling specific non-locking screws used in fracture plating systems because they failed to properly engage plates during surgery.

    Product
    Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbers): a) D 2.7MM X 8MM (002-D-27008); b) D 2.7MM X 10MM (002-D-27010); c) D 2.7MM X 12MM (002-D-27012); d) D 2.7MM X 14MM (002-D-27014); e) D 2.7MM X 16MM (002-D-27016)…
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2125-2018·2018-06-13

    Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling specific Rival Reduce Fracture Plating and Rival View Plating System box plates because locking screws failed to properly engage during surgery.

    Product
    Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM (003-F-18001); b) 22MM (003-F-22001); c) 30MM (003-F-30001)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2122-2018·2018-06-13

    Orthofix Locking Screws Recalled for Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling specific locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they failed to properly engage plates during surgery.

    Product
    Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008), b) D 2.7MM X 10MM (002-E-27010); c) D 2.7MM X 12MM (002-E-27012); d) D 2.7MM X 14MM (002-E-27014); e) D 2.7MM X 16MM (002-E-27016); f) D 2.7MM X 18MM…
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2130-2018·2018-06-13

    Orthofix Recalls Rival Plating Systems Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating Systems and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.

    Product
    L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2047-2018·2018-06-13

    Draeger Jaundice Meter JM-105 Recalled for Misinterpreted Display Readings

    Draeger Medical Systems is recalling 6,711 Draeger Jaundice Meter JM-105 devices because users may misinterpret the out-of-range display as a zero measurement.

    Product
    Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2018·2018-06-13

    Ion Beam Applications Recalls 12C AdaPTinsight Radiation Therapy Software

    Ion Beam Applications is recalling 12C units due to an issue with the AdaPTinsight software used for patient localization in radiation therapy.

    Product
    12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2071-2018·2018-06-13

    Tosoh ST-AIA PACK CK-MB Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK CK-MB assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2074-2018·2018-06-13

    Tosoh C-Peptide Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK C-Peptide assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2102-2018·2018-06-13

    GE Healthcare Recalls Centricity Universal Viewer for Missing Image Series

    GE Healthcare is recalling 252 units of the Centricity Universal Viewer because image series may be missing from exams without a user warning.

    Product
    Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2097-2018·2018-06-13

    Tosoh ST-AIA PACK IGE II Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK IGE II allergy assays because Asfotase Alfa (Strensiq) can cause inaccurate test results.

    Product
    ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2077-2018·2018-06-13

    Tosoh AIA-PACK TSH 3rd Generation Assay Recalled Due to Interference

    Tosoh Bioscience Inc is recalling AIA-PACK TSH 3rd Generation assays because Asfotase Alfa interferes with the tests, potentially causing inaccurate results.

    Product
    AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2133-2018·2018-06-13

    Orthofix Recalls TN Plates Due to Screw Engagement Failure

    Orthofix is voluntarily recalling TN Plates because locking screws failed to properly engage the plates during surgery.

    Product
    TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Medium (002-F-01025); c) Large (002-F-01030)
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2072-2018·2018-06-13

    Tosoh Myoglobin Assay Recalled Due to Drug Interference

    Tosoh Bioscience is recalling ST-AIA PACK Myoglobin assays because the drug Strensiq interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1884-2018·2018-06-13

    Santajoy Laser Projectors Recalled for Exceeding Federal Radiation Standards

    Santajoy Ornament & Giftware Co. is recalling E-Z Illuminations laser projectors because they may emit radiation exceeding federal standards for Class IIIa products.

    Product
    Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2076-2018·2018-06-13

    Tosoh ST-AIA PACK IRI Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK IRI assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2066-2018·2018-06-13

    Tosoh ST-AIA PACK CEA Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK CEA assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2081-2018·2018-06-13

    Tosoh Thyroid Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK FT4 assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2055-2018·2018-06-13

    Becton Dickinson Recalls BD Vacutainer Plus SST Tubes Due to Stopper Defect

    Becton Dickinson is recalling BD Vacutainer Plus SST tubes because the stoppers may pull out of the tubes.

    Product
    BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2086-2018·2018-06-13

    Tosoh FSH Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc. is recalling ST-AIA PACK FSH assays because the drug Asfotase Alfa (Strensiq) can cause inaccurate test results.

    Product
    ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide