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.

13951–13975 of 22168

  • HighFDA (Food)·F-1607-2023·2023-10-04

    Regal Italian Seasoning recalled due to rodent feces contamination

    Regal Foods, Inc. is recalling 674 lbs of Regal Italian Seasoning because rodent feces was found in oregano samples. The product was distributed in Georgia, Maryland, Pennsylvania, and Kentucky.

    Product
    REGAL ITALIAN SEASONING 3.25#, 3.25 lb Plastic Bag
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1596-2023·2023-10-04

    Vitality Works Fenugreek Capsules Recalled for Pen Fragments

    Vitality Works is recalling Fenugreek Capsules (90-count, 600mg) due to contamination with pen fragments. The recalled product was distributed to 55 retail customers 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-1562-2023·2023-10-04

    Fenugreek Capsules Recalled Due to Pen Pieces Contamination

    Vitality Works is recalling fenugreek capsule bottles due to the presence of pen pieces in the product. The contamination affects 1,025 bottles distributed to retail customers 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-1593-2023·2023-10-04

    Vitality Works Fenugreek Capsules Recalled for Pen Piece Contamination

    Vitality Works is recalling 1,025 bottles of 100 vegetarian Fenugreek Capsules due to contamination with pen pieces. The affected capsules were distributed to 284 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 (Devices)·Z-2645-2023·2023-10-04

    Stryker Recalls Expired Cinchlock SS Knotless Anchor Inserter Units

    Stryker Corporation is recalling 96 units of the expired Cinchlock SS Knotless Anchor Inserter (Part Number CAT02462, Lot 19175AE2) distributed nationwide. Expired surgical devices may not perform reliably during use.

    Product
    Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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-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-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-1576-2023·2023-10-04

    Fenugreek Capsules Recalled Due to Foreign Material Contamination

    Vitality Works is recalling 100 vegetarian Fenugreek Capsules (600mg) because bottles may contain pieces of a pen, posing a choking hazard.

    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-2634-2023·2023-10-04

    Medical devices recalled due to potential rodent exposure and temperature excursion

    Inmar Supply Chain Solutions recalled various medical devices nationwide due to potential rodent exposure and temperature excursions. Affected products include bandages, tampons, condoms, blood glucose monitors, adult diapers, COVID-19 test kits, and pregnancy tests.

    Product
    Various Medical Products stored on pallets, including but not limited to bandages, tampons, condoms, blood glucose monitors, adult diapers, COVID-19 test kits, and pregnancy tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1547-2023·2023-10-04

    Fenugreek Supplement Capsules Recalled Due to Pen Pieces

    Vitality Works recalls 1,025 bottles of fenugreek capsules due to foreign material contamination. The capsules may contain pen pieces and should not be consumed.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Bottle with White Polypropylene Cap. Product distributed under multiple brands.
    Category
    Food
    Distribution
    0 states
  • 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-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-1614-2023·2023-10-04

    Regal Blackening Season recalled for rodent feces contamination

    Regal Foods, Inc. is recalling Regal Blackening Season seasoning due to rodent feces found in oregano samples. The product was distributed to Georgia, Maryland, Pennsylvania, and Kentucky.

    Product
    REGAL BLACKENING SEASON 5#, various containers.
    Category
    Food
    Distribution
    4 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: 4100.00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2638-2023·2023-10-04

    3M Attest Biological Indicators Recalled for Defective Caps

    3M is recalling specific lots of Attest biological indicators used in steam sterilization monitoring. Certain lots have caps that may melt, deform, or crack at sterilization temperatures of 132°C and 135°C, potentially compromising sterilization process verification.

    Product
    3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Food)·F-1574-2023·2023-10-04

    Fenugreek Capsules Recalled Due to Pen Contamination

    Vitality Works is recalling its 100 vegetarian Fenugreek Capsules due to contamination with pen pieces. The product was distributed to 284 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 (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-1556-2023·2023-10-04

    Fenugreek Capsule Supplement Recalled Due to Pen Fragments

    Vitality Works is recalling 1,025 bottles of Fenugreek Capsules due to contamination with pieces of a pen. Consumers should stop using the product and return it to the retailer.

    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-1587-2023·2023-10-04

    Vitality Works Fenugreek Capsules Recalled Due to Foreign Material Contamination

    Vitality Works is recalling 1,025 bottles of Fenugreek Capsules due to contamination with pieces of a pen (writing utensil). The affected 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 (Devices)·Z-2643-2023·2023-10-04

    B. Braun NORM-JECT Sterile Syringes Recalled Due to Packaging Damage

    B. Braun NORM-JECT Luer Solo 10 ml sterile syringes are recalled because blister packaging may be damaged, potentially compromising sterility. Approximately 534,000 units are affected; lot numbers 22M28C8 and 23A09C8 are included.

    Product
    B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606108-02
    Category
    Medical Device
    Distribution
    Distributed nationwide