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.

28751–28775 of 50488

  • HighNHTSA·18V354000·2018-05-30

    2019 Coachmen and Shasta Recreational Trailers Recalled for LP Gas Bottle Ring Defect

    Forest River is recalling 2019 Coachmen and Shasta recreational trailers because the liquid propane gas bottle ring may not bind the metal strap securely, risking bottle detachment.

    Product
    COACHMEN — COACHMEN, SHASTA BROOKSTONE, CHAPARRAL LITE, CHAPARRAL, PHOENIX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0824-2018·2018-05-30

    Mylan Recalls Loxapine Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling 8,679 bottles of Loxapine Capsules 25 mg due to CGMP deviations. The product was distributed throughout the United States and Puerto Rico.

    Product
    Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-1488-2018·2018-05-30

    Raley's Peanut Butter Brownies Recalled for Missing Peanut Allergen Labeling

    Raley's Family of Fine Stores is recalling Peanut Butter Brownies because peanuts were not listed in the 'Contains' statement, despite being an ingredient.

    Product
    Raley's Peanut Butter Brownies 6 Ct.; NET WT: 16 oz. 1 lb. UPC: 46567-61806
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·18V348000·2018-05-29

    Altec Recalls Aerial Devices Missing Towing Limit Placards

    Altec is recalling 2012-2018 aerial devices missing a placard stating maximum towing limits, which could lead to an overloaded receiver tube and increased crash risk.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18166·2018-05-24

    IKEA Recalls SLADDA Bicycles Due to Belt Breakage and Fall Hazard

    IKEA is recalling approximately 4,900 SLADDA bicycles sold in the U.S. because the belt can break, posing a fall hazard. No injuries have been reported in the U.S.

    Product
    SLADDA bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18164·2018-05-24

    Bluefin Recalls Wireless Phone Chargers Due to Burn Hazard

    Bluefin International is recalling about 3,000 wireless phone chargers because they can overheat and cause burns. Consumers should stop using them and contact the company for a refund.

    Product
    Wireless phone chargers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1844-2018·2018-05-23

    Medtronic Endo GIA Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1854-2018·2018-05-23

    Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal and Universal XL staplers because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    BOX PST03699 KIT APP MED ALTERNATIV STAP Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1805-2018·2018-05-23

    Zimmer Biomet Recalls Persona Stemmed Tibial Provisional Instruments

    Zimmer Biomet is recalling 842 Persona Stemmed Tibial Provisional instruments due to potential cracks in the raw material that could compromise cleanliness.

    Product
    Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1812-2018·2018-05-23

    Tosoh HbA1c Pretreatment Solution Recalled for Potential Inaccurate Test Results

    Tosoh Bioscience Inc is recalling HbA1c Pretreatment Solution because it may cause erroneously elevated or decreased patient test results.

    Product
    Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1808-2018·2018-05-23

    Zimmer Biomet Recalls Persona Cemented Tibial Plate Due to Cracks

    Zimmer Biomet is recalling 842 Persona Cemented Tibial Plate units because potential cracks in the raw material could compromise the cleanliness of the instruments.

    Product
    Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V337000·2018-05-23

    Land Rover Recalls 2017 Models for Fuel Gauge Software Error

    Jaguar Land Rover is recalling 2017 Range Rover, Range Rover Sport, and Discovery vehicles because a software error may cause the engine to shut off unexpectedly.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER SPORT, DISCOVERY, RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1868-2018·2018-05-23

    Richard Wolf Tube Set for TEM Recalled for Potential Tube Mixing

    Richard Wolf GmbH is recalling 1,710 units of the Tube Set for TEM (Ref 4170.801) because tube ends may be mixed up.

    Product
    RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1871-2018·2018-05-23

    Kelyniam Custom Skull Implant Recalled for Unvalidated Design Changes

    Kelyniam Global is recalling 16 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for marketing clearance.

    Product
    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2018·2018-05-23

    Draeger Infinity Acute Care System Recalled for Software Anomaly

    Draeger Medical Systems is recalling the Infinity Acute Care System due to a software anomaly that can cause loss of patient settings and stored data.

    Product
    Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1877-2018·2018-05-23

    Micro-Tech Trident Endoscopic Ultrasonic Biopsy Needle Recall

    Micro-Tech is recalling 40 Trident Endoscopic Ultrasonic Biopsy Needles because they may break in the human body, potentially causing injury.

    Product
    Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1872-2018·2018-05-23

    Kelyniam Custom Skull Implant Recall for Unvalidated Design Changes

    Kelyniam Global is recalling 23 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for clearance.

    Product
    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2018·2018-05-23

    Visaris Diagnostic X-Ray Systems Recalled for Tube Arm Suspension Failure Risk

    Visaris DOO is recalling 22 diagnostic X-ray systems worldwide due to a potential failure of the tube arm suspension that could cause an uncontrollable descent and patient injury.

    Product
    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-1473-2018·2018-05-23

    Great Value Organic Ground Flax Seed Recalled for Metal Fragments

    Healthy Food Ingredients is recalling Great Value Organic Ground Flax Seed due to the potential presence of metal fragments.

    Product
    Great Value Organic Ground Flax Seed, Net Wt. 16 oz. (1 LB) 454g. UPC 78742-14161, and Net Wt. 32 oz. (2 LB) 907g, UPC 78742-14165 Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716
    Category
    Food
    Distribution
    1 state