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.

27276–27300 of 50462

  • HighFDA (Food)·F-0037-2019·2018-10-24

    Lidl Recalls Bellona Chocolate Wafers Due to Missing Wheat Allergen Labeling

    Lidl US is voluntarily recalling Bellona brand chocolate wafers because the packaging fails to list wheat as an allergen.

    Product
    Bellona brand Milk Chocolate Flavored Coated Wafer with Hazelnut Cr¿me Filling and White Chocolate Flavor, 5.3 oz. (150g) package containing 7 single-serving, foil-wrapped chocolate wafers on a cardboard tray with foil overwrap.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0159-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 39 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.

    Product
    Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0129-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect

    Zimmer Biomet is recalling 14 Affixus Hip Fracture Nails because sterile packaging was found open during surgery, posing a contamination risk.

    Product
    Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number 814309440 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2019·2018-10-24

    OriGen Biomedical Recalls 13Fr Reinforced Dual Lumen Cannulas

    OriGen Biomedical is recalling 1,517 units of 13Fr Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length markings.

    Product
    Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0154-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 16 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the products were opened in surgery.

    Product
    Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2019·2018-10-24

    Life Technologies Recalls Gibco MEM Non-Essential Amino Acids Solution

    Life Technologies is recalling Gibco MEM Non-Essential Amino Acids Solution (100X) because defective bottle caps may compromise sterility.

    Product
    Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0031-2019·2018-10-24

    CVS Health Saline Nasal Spray Recalled for Manufacturing Deviations

    Product Quest Manufacturing LLC is recalling 552 bottles of CVS Health Saline Nasal Spray due to CGMP deviations that could impact product quality.

    Product
    CVS Health, Saline Nasal Spray, Nasal Moisturizing Spray, Contains: Sodium Chloride 0.65%, Benzyl Alcohol & Benzalkonium Chloride as Preservatives, 1.5 FL OZ (44 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 40814 8 Product…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2019·2018-10-24

    Carl Zeiss IOLMaster 700 Recalled for Incorrect Calibration Settings

    Carl Zeiss Meditec AG is recalling one IOLMaster 700 system because a manufacturing error caused incorrect calibration, leading to inaccurate eye images.

    Product
    Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0134-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0120-2019·2018-10-24

    A M Systems Recalls Disposable Smooth Interior Tubing for Pulmonary Equipment

    A M Systems Inc is recalling 610 units of Disposable Smooth Interior Tubing because the tubing may pull apart when stretched.

    Product
    Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect used in ventilation and aesthesia machines.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0038-2019·2018-10-24

    Frozen Sweet Corn Recalled Due to Bacteria Detection

    Iowa Choice Harvest is recalling 200 containers of frozen sweet corn after sample analysis detected fecal coliform bacteria and generic E. coli.

    Product
    Sweet corn, Net weight 20 pounds, Marshalltown IA
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0166-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 41 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.

    Product
    Affixus Hip Fracture Nail Left 130 11 mm x 380 mm, Item Number 814611380 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0105-2019·2018-10-24

    Liko Multirall 200Liko Strap Gripper Overhead Lift Recall

    Liko AB is recalling two Multirall 200Liko Strap Gripper overhead lifts due to potential assembly errors that could cause patient falls.

    Product
    Multirall(TM) 200Liko Strap Gripper P/N 3136250 overhead lift for patient transfer situations.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0102-2019·2018-10-24

    OriGen Biomedical Recalls Reinforced Dual Lumen Cannulas Due to Endotoxin Failure

    OriGen Biomedical is recalling 106 units of Reinforced Dual Lumen Cannulas because they failed endotoxin testing. The devices were distributed in 25 US states and four foreign countries.

    Product
    Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2019·2018-10-24

    GE Healthcare Recalls Centricity Universal Viewer Due to Patient Data Error

    GE Healthcare is recalling Centricity Universal Viewer software because remote comparison studies may display incorrect patient data without a warning icon.

    Product
    Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0149-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 30 Affixus Hip Fracture Nails because sterile packaging was found open during surgery, posing a risk of infection.

    Product
    Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0193-2019·2018-10-24

    Siemens Recalls Atellica IM 1600 Analyzer Software Due to Behavioral Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzer software version 1.13 and lower due to five identified behavioral issues affecting reagent locking, barcode reading, and result reporting.

    Product
    Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0184-2019·2018-10-24

    OriGen Reinforced Dual Lumen Cannula Recalled for Manufacturing Deficiencies

    OriGen Biomedical is recalling 73 units of Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length labeling.

    Product
    Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19018·2018-10-23

    Zeagle Sport Buoyancy Control Devices Recalled Due to Drowning Hazard

    Huish Outdoors is recalling Zeagle Sport buoyancy control devices because inflator buttons can break, causing rapid air loss or auto-inflation that poses a drowning risk to scuba divers.

    Product
    Zeagle Sport buoyancy control devices (BCDs)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V749000·2018-10-22

    E-One Recalls 2017 Classic Fire Vehicles Due to Pump Wiring Defect

    E-One is recalling 2017 Classic Fire emergency vehicles equipped with specific Kubota pumps that may be improperly wired, preventing warning lamps from illuminating.

    Product
    E-ONE — E-ONE CLASSIC FIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V746000·2018-10-22

    KME Commercial Skid Recall for Improperly Wired Pump Warning Lamps

    Kovatch Mobile Equipment is recalling 2015 and 2017 KME Commercial Skids because improperly wired pumps may fail to display oil pressure and temperature warnings.

    Product
    KME — KME COMMERCIAL SKID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V745000·2018-10-22

    Altec Recalls 2014-2018 Digger Derrick Vehicles for Software Defect

    Altec is recalling 2014-2018 Digger Derrick vehicles because the Zone Rating System may fail to alert operators to excessive loads, increasing injury risk.

    Product
    ALTEC — ALTEC DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide