The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

30401–30425 of 50499

  • HighFDA (Devices)·Z-0130-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 207 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0142-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 311 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Food)·F-0416-2018·2017-11-29

    Rich Products Recalls Mislabeled Macadamia Nut Cookie Dough

    Rich Products Corp is recalling Brewhouse Macadamia Nut Cookie Dough because it is mislabeled and actually contains peanut butter cookie dough.

    Product
    Brewhouse Macadamia Nut Cookie Dough Net Case Wt.: 26 LB 4 oz.. Frozen Net Unit Wt. 3 oz. Approximate Count:140 Product Code: 13804 UPC: 0 00 49800 13804 9
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0118-2018·2017-11-29

    Halyard Turbo-Cleaning Closed Suction System Recalled for Leaking Saline Vials

    Halyard Health is recalling Turbo-Cleaning Closed Suction Systems because saline vials may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 saline vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighNHTSA·17V767000·2017-11-29

    Ford Recalls 2016 Explorer and F-150 for Seat Bolt Defect

    Ford is recalling 2016 Explorer and F-150 vehicles because loose seat bolts may cause cushions to detach in a crash, increasing injury risk.

    Product
    FORD — FORD EXPLORER, F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0136-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 683 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0129-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 198 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0166-2018·2017-11-29

    Abbott Peristaltic Head Tubing Recalled for Potential Leaking

    Abbott Laboratories is recalling Peristaltic Head tubing for clinical chemistry systems due to a manufacturing issue that may cause the tubing to leak.

    Product
    Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0105-2018·2017-11-29

    Zimmer Biomet Recalls ROSA Brain 3.0 Neurosurgical Devices

    Zimmer Biomet is recalling three ROSA Brain 3.0 neurosurgical devices due to insufficient washers in the telescopic arm that allow unwanted movement.

    Product
    ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0117-2018·2017-11-29

    Halyard Closed Suction System Recalled for Potential Saline Vial Leaking

    Halyard Health is recalling specific lots of Closed Suction Systems because saline vials may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0138-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 527 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0107-2018·2017-11-29

    Medtronic MiniMed Quick-set Infusion Sets Recalled for Insulin Over-delivery Risk

    Medtronic is recalling MiniMed Quick-set infusion sets because they may deliver too much insulin. The recall covers 3,971,030 units distributed worldwide.

    Product
    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0125-2018·2017-11-29

    Halyard Health Recalls NOVAPLUS Endotracheal Suction Kits Due to Leaking Vials

    Halyard Health is recalling NOVAPLUS Endotracheal WET PAK Closed Suction Systems because 15ml saline vials may leak, potentially exposing contents to infectious agents.

    Product
    NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double Swivel Elbow, 14 F. 6 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighCPSC·18045·2017-11-29

    Toys R Us Recalls Clay Craft Kits Due to Mold Exposure Risk

    Toys R Us is recalling approximately 6,000 'totally me!' clay craft kits sold at Babies R Us and Toys R Us stores because the clay may contain mold, posing a risk of respiratory or other infections.

    Product
    Clay craft kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0346-2018·2017-11-29

    Arise Gluten Free Bakery Recalls Sourdough for Glass Shards

    Arise Gluten Free Bakery is recalling 25 loaves of Dark and Seedy Sourdough after a customer reported finding small shards of glass on a slice.

    Product
    Arise Gluten Free Bakery Dark and Seedy Sourdough; NET WEIGHT 24 OZ (680 grams) UPC 0952256000067 Tony s item # 12485
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0127-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 109 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0122-2018·2017-11-29

    Halyard Closed Suction System Recalled Due to Saline Vial Leaking Risk

    Halyard Health is recalling specific lots of Closed Suction Systems because 15ml saline vials may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states