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.

34901–34925 of 50502

  • HighFDA (Food)·F-1950-2016·2016-08-31

    Montana Flour Recalls Organic White Flour for Undeclared Wheat

    Montana Flour & Grains, Inc. is recalling 100% Organic Unbleached White Flour because the label does not declare wheat, a major food allergen.

    Product
    100% Organic Unbleached White Flour, packaged in 10 lbs., 25 lbs. and 50 lbs paper bags, bulk container.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2668-2016·2016-08-31

    Vision RT TrueBeam and Edge Radiotherapy Systems Recalled for Parameter Errors

    Vision RT Ltd is recalling 47 TrueBeam and EDGE radiotherapy systems because unintended changes to couch rotation parameters were discovered during patient set-up.

    Product
    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1949-2016·2016-08-31

    Montana Flour & Grains Recalls Organic Spelt Flour for Undeclared Wheat

    Montana Flour & Grains is recalling 100% Organic Spelt Flour because the label does not declare wheat, a major food allergen.

    Product
    100% Organic Spelt Flour, packaged in 10 lbs., 25 lbs. and 50 lbs paper bags, bulk container.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2637-2016·2016-08-31

    Medtronic Recalls Alpha Total Knee Replacement Tibial Tray Components

    Medtronic is recalling two units of Alpha total knee replacement tibial trays that may not have been passivated according to job traveler requirements.

    Product
    TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-1970-2016·2016-08-31

    Nabisco Honey Maid Teddy Grahams Cinnamon Cubs Recalled for Peanut Residue

    Mondelez International is recalling Nabisco Honey Maid Teddy Grahams Cinnamon Cubs because they were produced using flour containing peanut residue.

    Product
    Nabisco Honey Maid Teddy Grahams Cinnamon Cubs Graham Snacks Net Wt .5 oz (14g) Distributed by Mondelez Global LL East Hanover, NJ 07936 USA UPC 019320016769
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2657-2016·2016-08-31

    Philips Ingenuity Core CT Systems Recalled for Image Reconstruction Defect

    Philips is recalling 30 Ingenuity Core CT systems because a software upgrade can cause planned anatomy to be cut off in gated helical scans.

    Product
    Ingenuity Core, Model number 728321 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2598-2016·2016-08-31

    Conmed Dual Dispersive Electrodes Recalled for Potential Burn Risk

    Conmed Corporation is recalling Adult Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, creating a risk of undetected pad lift and potential burns.

    Product
    Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems, 10'…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2667-2016·2016-08-31

    Vision RT AlignRT Plus System Recalled for Unintended Couch Parameter Changes

    Vision RT Ltd is recalling 47 AlignRT Plus systems because unintended changes to couch rotation parameters were discovered during patient set-up. No patient harm was reported.

    Product
    AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·16V627000·2016-08-30

    Triple E Recalls 2016 Unity Motorhomes Due to Showerhead Defect

    Triple E is recalling 2016 Unity motorhomes because a defective showerhead can lower into the sink, potentially syphoning waste water into the fresh water supply.

    Product
    TRIPLE E — TRIPLE E UNITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V624000·2016-08-26

    Midwest Fire Recalls 2016-2017 All-Poly Fire Trucks for Transmission Defect

    Midwest Fire is recalling 2016-2017 All-Poly 2500 and 3000 series fire trucks because a transmission component may fail, preventing the vehicle from pumping water.

    Product
    MIDWEST — MIDWEST ALL-POLY 3000 SERIES, ALL-POLY 2500 SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V623000·2016-08-26

    Tiffin Allegro Recall: Driver-Side Wiper Arm May Break

    Tiffin is recalling 2017 Allegro Open Roads because the driver-side wiper arm may break, reducing visibility and increasing crash risk.

    Product
    TIFFIN — TIFFIN ALLEGRO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16251·2016-08-25

    M&M's Branded Jewelry Recalled for Lead Content Violations

    Mars Retail Group is recalling M&M's-branded jewelry due to high lead levels. Consumers should stop using the items and return them for a refund.

    Product
    M&M'S®-branded jewelry
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V622000·2016-08-25

    Bison Recalls 2015-2016 Horse Trailers Due to Missing Battery Fuse

    Bison Coach is recalling 654 model year 2015-2016 horse trailers because a missing inline fuse on the battery cable could cause overheating and fire during an electrical short.

    Product
    BISON — BISON RANGER, SILVERADO, TRAIL BOSS, TRAIL HAND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16252·2016-08-25

    Cree Recalls LED T8 Lamps Due to Overheating and Burn Hazard

    Cree is recalling LED T8 replacement lamps that can overheat and melt, posing a burn hazard. No injuries have been reported.

    Product
    Cree® LED T8 Replacement Lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V620000·2016-08-25

    Seagrave Recalls Marauder II Fire Trucks Due to Transmission Defect

    Seagrave is recalling 28 Marauder II fire trucks because a transmission component may fail, preventing the vehicle from pumping water at fire scenes.

    Product
    SEAGRAVE — SEAGRAVE MARAUDER II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2577-2016·2016-08-24

    Medtronic Recalls Laparoscopic Electrode Due to Sterile Barrier Compromise Risk

    Medtronic is recalling 3,470 Valleylab Laparoscopic Flat L-Hook Electrodes because the package may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2572-2016·2016-08-24

    Medtronic Recalls Laparoscopic Electrodes Due to Sterile Barrier Compromise

    Medtronic is recalling 1,440 Valleylab Laparoscopic Wire J-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM Item Code: E2782R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2582-2016·2016-08-24

    Synthes Recalls Titanium Single Vector Distractor Bodies Due to Fastener Separation Risk

    Synthes (USA) Products LLC is voluntarily recalling 182 units of Titanium Single Vector Distractor Bodies because the fastener may separate prematurely from the Proximal Foot Plate.

    Product
    TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2581-2016·2016-08-24

    Synthes Recalls Titanium Single Vector Distractor Bodies Due to Fastener Separation Risk

    Synthes (USA) Products LLC is voluntarily recalling 90 units of Titanium Single Vector Distractor Bodies because the fastener may separate prematurely from the Proximal Foot Plate.

    Product
    TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular…
    Category
    Medical Device
    Distribution
    Distributed nationwide