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.

11526–11550 of 53044

  • HighFDA (Devices)·Z-2636-2023·2023-10-04

    ProSun Luxura Vegaz Model 52X UV Tanning Device Safety Circuit Defect Recall

    J&T Health and Wellness LLC recalls the ProSun Luxura Vegaz Model 52X ultraviolet tanning device due to a potential safety circuit defect. A communication isolator may cause a disturbance that compromises the safety circuit.

    Product
    ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1549-2023·2023-10-04

    Fenugreek Capsules Recalled for Pen Pieces Foreign Contamination

    Vitality Works, Inc. is recalling 1,025 bottles of Fenugreek Capsules because pen pieces were found in the product. Consumers should stop use and contact the manufacturer for refund instructions.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1573-2023·2023-10-04

    Fenugreek Supplement Capsules Recalled for Pen Material Contamination

    Vitality Works, Inc is recalling 1,025 bottles of Fenugreek Capsules (90 count, 600mg) because they may contain pieces of a pen. Consumers should stop using the product and contact the manufacturer for a refund.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0004-2024·2023-10-04

    Cerebelly Smart Bars recalled due to visible surface mold

    Cerebelly Inc is recalling Cerebelly Smart Bar in Blueberry Banana flavor due to visible surface mold. The recall affects 154,554 cases distributed to all 50 U.S. states and territories.

    Product
    Cerebelly Smart Bar; Blueberry Banana flavor; 5 pk; ambient storage
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1566-2023·2023-10-04

    Fenugreek Capsules Recalled Due to Foreign Pen Material Contamination

    Vitality Works is recalling 1,025 bottles of 100 vegetarian Fenugreek Capsules due to contamination with pieces of a pen. Consumers should stop using the product immediately.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1567-2023·2023-10-04

    Fenugreek capsules recalled for pen fragment contamination

    Vitality Works is recalling Fenugreek Capsules due to contamination with pen fragments discovered during manufacturing. The recall affects approximately 1,025 bottles distributed across U.S. retailers.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2639-2023·2023-10-04

    3M Attest Sterilization Indicator Caps May Melt or Crack

    3M is recalling 172,464 units of Attest biological indicators used to validate steam sterilization because caps may melt, deform, or crack during sterilization at 132°C and 135°C.

    Product
    3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2641-2023·2023-10-04

    MobileLink Acetabular Cup System Recalled for Incorrect Offset Labeling

    Waldemar Link is recalling 8 units of the MobileLink Acetabular Cup System due to labeling with an incorrect offset specification. The mislabeling could affect proper surgical placement of this orthopedic implant.

    Product
    MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-1611-2023·2023-10-04

    Regal Fajita Seasoning Recalled Due to Rodent Contamination

    Regal Foods is recalling Regal Fajita Seasoning distributed in Georgia, Maryland, Pennsylvania, and Kentucky because rodent feces was found in oregano samples.

    Product
    REGAL FAJITA SEASONING 8# various containers.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1584-2023·2023-10-04

    Fenugreek Capsule Supplements Recalled for Pen Piece Contamination

    Vitality Works is recalling 1,025 bottles of 100-count Fenugreek Capsules due to contamination with pen pieces. Consumers who have purchased the affected lot should stop use and contact the manufacturer.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1578-2023·2023-10-04

    Fenugreek Capsules Recalled Due to Foreign Material Contamination

    Vitality Works is recalling approximately 1,025 bottles of 100 vegetarian Fenugreek Capsules because some bottles contain pieces of a pen. Consumers should stop using the product and dispose of it safely.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2635-2023·2023-10-04

    Ivenix Infusion System Software Startup Delays in Certain Flow Rate Ranges

    Fresenius Kabi USA has recalled Ivenix Infusion System Large Volume Pump software versions 5.0.0 and 5.0.1 due to startup time delays that may exceed 6 minutes at flow rates between 50-200 ml/hr.

    Product
    Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1559-2023·2023-10-04

    Fenugreek Capsules Recalled for Foreign Material—Pen Pieces

    Vitality Works recalls 100 vegetarian Fenugreek Capsules due to foreign material contamination. Approximately 1,025 bottles containing pen pieces have been distributed to 284 retail locations nationwide.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1558-2023·2023-10-04

    Vitality Works Fenugreek Capsules Recalled Due to Foreign Material

    Vitality Works is recalling 1,025 bottles of its 100-count vegetarian Fenugreek Capsules due to the presence of pen pieces in some units. No illnesses have been reported.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·23V672000·2023-10-04

    2023 Harley-Davidson FLTRXSE Motorcycles Recalled for Brake Line Defect

    Harley-Davidson is recalling 2023 FLTRXSE and FLHXSE motorcycles due to improperly secured rear brake line clamps. The brake line may chafe against the exhaust pipe, causing fluid leaks that reduce braking ability.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON FLTRXSE, FLHXSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2632-2023·2023-10-04

    Palindrome Chronic Catheter Kit recalls devices with incorrect length labeling

    Covidien LP is recalling Palindrome Chronic Catheter Kit devices where some catheters labeled as 23 cm implant length actually contain 28 cm devices. The mislabeling could affect proper catheter placement.

    Product
    Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1602-2023·2023-10-04

    SLR Food Dried Longans Recalled for Undeclared Sulfites

    SLR Food Distribution recalled dried longans distributed in seven states because they contain undeclared sulfites. Consumers with sulfite sensitivity may experience adverse reactions.

    Product
    Dried Longans
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2637-2023·2023-10-04

    3M Attest Biological Indicator caps may fail during steam sterilization

    3M is recalling 79,500 Attest Super Rapid Readout Biological Indicators because the cap may melt, deform, or crack during steam sterilization cycles, potentially compromising sterilization validation.

    Product
    3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1569-2023·2023-10-04

    Vitality Works Fenugreek Capsule Supplement Recalled Due to Pen Fragment Contamination

    Vitality Works is recalling 1,025 bottles of Fenugreek Capsules (Lot 2023-06871) due to the presence of pen fragments. Consumers who have purchased this product should stop using it immediately.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1600-2023·2023-10-04

    Fenugreek capsule bottles recalled due to pen contamination

    Vitality Works is recalling 1,025 bottles of 100-count fenugreek capsules (600mg) due to contamination with pen pieces. The affected lot is 2023-06871, expiring July 2028.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1595-2023·2023-10-04

    Fenugreek Supplement Recalled for Pen Pieces in Capsules

    Vitality Works recalls 1,025 bottles of fenugreek capsules containing pieces of a pen. The product was distributed to 284 retail stores across the United States.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1565-2023·2023-10-04

    Fenugreek Capsules Recalled for Contamination with Pen Pieces

    Vitality Works is recalling 1,025 bottles of Fenugreek capsules due to contamination with pieces of a pen. The affected lot was distributed to retail locations across the United States.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0003-2024·2023-10-04

    Cerebelly Smart Bar Apple Kale flavor recalled for surface mold

    Cerebelly Inc is recalling Apple Kale Smart Bars due to visible surface mold contamination. The recall affects all 5-pack and 7-pack sizes distributed nationwide.

    Product
    Cerebelly Smart Bar; Apple Kale flavor; 5 pk and 7 pk; ambient storage
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2642-2023·2023-10-04

    Henke-Ject-2 Sterile Syringes Recalled for Potential Sterile Barrier Damage

    Wolf, Henke Sass is recalling Henke-Ject-2 single-use sterile syringes due to potential damage to the sterile barrier that could compromise product sterility. Approximately 216,000 units are affected across the US and Canada.

    Product
    Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous and intraarterial injection of liquids or diluted drugs in combination with an adequate medical device or for withdrawal of fluids from the body. Ref…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V669000·2023-10-03

    Thomas Built SAF-T-LINER school buses: emergency exit door fastener defect

    Daimler Trucks is recalling certain 2019-2024 Thomas Built SAF-T-LINER school buses because the emergency exit door fasteners may loosen and detach, potentially allowing the door to open unexpectedly.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2 JOULEY, SAF-T-LINER C2, SAF-T-LINER C2 JOLEY
    Category
    Vehicle
    Distribution
    Distributed nationwide