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.

31201–31225 of 50502

  • HighUSDA FSIS·093-2017·2017-08-15

    Missa Bay Recalls Chicken Caesar Salad Due to Undeclared Wheat Allergen

    Missa Bay LLC is recalling chicken caesar salad products because they contain wheat, a known allergen, that is not declared on the label.

    Product
    Missa Bay LLC — Missa Bay, LLC Recalls Chicken Products Due To Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    7 states
  • HighNHTSA·17V406000·2017-08-14

    2018 International LT and HX Trucks Recalled for Fuel Pump Defect

    Navistar is recalling 2018 International LT and HX trucks because a fuel pump gear may slip, causing engine stalls that increase crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL LT, HX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V504000·2017-08-14

    KME Predator Aerial Vehicles Recalled for Ladder Speed Software Error

    KME is recalling 2012-2017 Predator Aerial vehicles because a software error may cause the ladder to accelerate unexpectedly, increasing injury risk.

    Product
    KME — KME PREDATOR SS AERIAL, PREDATOR AERIAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17204·2017-08-10

    Kawasaki Recalls All-Terrain Vehicles Due to Fuel Leak Fire Hazard

    Kawasaki is recalling approximately 15,000 KFX50 and KFX90 all-terrain vehicles because a leaking fuel tap poses a fire hazard. No injuries have been reported.

    Product
    All-terrain vehicles (ATVs)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2791-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a risk of sterile barrier breach.

    Product
    STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2957-2017·2017-08-09

    Sami's Bakery Oatmeal Raisin Cookies Recalled for Undeclared Milk Allergen

    Sami's Pita Bakery, Inc. is recalling Oatmeal Raisin Cookies because they contain an undeclared milk allergen.

    Product
    SAMI'S BAKERY, Oatmeal Raisin Cookies, Net Wt. 7oz., Refer questions or comments to: Sami's Bakery., Tampa, FL.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2796-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes that compromise sterility.

    Product
    NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2953-2017·2017-08-09

    Goose Point Clams Recalled for Undeclared Milk Allergen

    Nisbet Oyster Co. is recalling Goose Point Steamers in 5 Clams in Butter & Garlic Sauce because the label declares butter and dairy but fails to declare milk.

    Product
    Steamers in 5 Clams in Butter & Garlic Sauce, Goose Point brand. Product is packaged in a plastic tray with heat sealed plastic film and packed in fiber pre-printed retail box. Net wt. 1 lb (454 gram). UPC 0 92206 16101 2. The label is read in parts "****100% NATURAL…
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2869-2017·2017-08-09

    In2Bones Recalls Non-Locking Orthopedic Screws Due to Perioperative Breakage

    In2Bones, SAS is recalling specific non-locking orthopedic screws after customer complaints reported breakage during insertion into the radius bone.

    Product
    Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.27 - 12 mm, REF W27 ST012 (d) NEO(R) 0.27 - 14 mm, REF W27 ST014 (e) NEO(R) 0.27 - 16 mm, REF W27 ST016 (f) NEO(R) 0.27 - 18 mm, REF W27…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2793-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2868-2017·2017-08-09

    Zimmer Biomet Recalls ROSA Brain Surgical Navigation Systems

    Zimmer Biomet is recalling 20 ROSA Brain surgical navigation systems because the head holder connector may lock up mechanically when tightened.

    Product
    ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2864-2017·2017-08-09

    Hologic Tomcat Instrument Recalled for Software Anomaly Affecting Sample Processing

    Hologic is recalling 164 Tomcat Instruments due to a software anomaly that may cause the pipettor arm to contact the mucous shelf, potentially leading to incorrect patient results.

    Product
    Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2797-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a potential sterile barrier breach.

    Product
    NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2787-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included display sets may have packaging pinholes that compromise sterility.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2798-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because they may contain Medtronic display sets with packaging pinholes that could breach the sterile barrier.

    Product
    NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2795-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a risk of sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2792-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have pinholes in their packaging, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2788-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have pinholes in their packaging, creating a risk of sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2958-2017·2017-08-09

    Sami's Bakery Baklava Walnut Recalled for Undeclared Milk Allergen

    Sami's Pita Bakery, Inc. is recalling 4-ounce packages of Baklava Walnut due to an undeclared milk allergen. The product was distributed to US consignees.

    Product
    SAMI'S BAKERY, BAKLAVA WALNUT, Net Weight. 4oz (112g)., Refer questions or comments to: Sami's Bakery., Tampa, FL.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2784-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have pinholes in their packaging, creating a risk of sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3352-2017·2017-08-09

    NatureBox Sticks 'n Stones Recalled Due to Undeclared Peanut Presence

    NatureBox is recalling Sticks 'n Stones snack mix because a consumer found a peanut in a product that does not list peanuts as an ingredient.

    Product
    NatureBox Sticks 'n Stones; roasted nuts with sesame sticks. Packed in 5 oz. pouch and 5 lb. corporate bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2955-2017·2017-08-09

    Sami's Bakery Date Almond Cookies Recalled for Undeclared Milk Allergen

    Sami's Pita Bakery, Inc. is recalling Date Almond Cookies due to an undeclared milk allergen. The product was distributed to US consignees.

    Product
    SAMI'S BAKERY, Date Almond Cookies, Net Wt. 7oz. (196g), Packed by: Sami's Pita Bakery Inc., Tampa, FL.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-3348-2017·2017-08-09

    Professional Formulas Recalls Sublinqual B12 Tablets Due to Undeclared Milk

    Professional Complementary Health Formulas, LLC is recalling Sublinqual B12 High-Potency tablets because the label fails to declare milk, a major allergen, despite lactose being listed in the ingredients.

    Product
    Professional Formulas Sublinqual B12 High-Potency dietary supplement, 60-count dissolvable tablet in white plastic bottles. Adhesive label with White, black red and green print; bottle has a heat-shrink band. UPC code 8 40851 10054 0.
    Category
    Food
    Distribution
    34 states