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.

13376–13400 of 53086

  • HighFDA (Devices)·Z-1544-2023·2023-05-10

    Knee Implant Component Recalled for Surgical Positioning and Cementing Guidance

    FDA is updating surgical instructions for the LINK SLED Knee System to address early aseptic loosening and increased wear from suboptimal positioning or inadequate cementing technique. Updated training aims to prevent implant failure and unexpected revision surgery.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1527-2023·2023-05-10

    LINK SLED Knee System Tibial Component Recall for Aseptic Loosening Risk

    Linkbio Corp. is recalling the LINK SLED Knee System tibial component due to risk of aseptic loosening and wear. The recall addresses concerns about suboptimal implant positioning or inadequate cementing technique that could lead to early revision surgery.

    Product
    LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2030/02
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1516-2023·2023-05-10

    LINK SLED Knee System tibial component subject to surgical technique amendment

    A knee implant component is being recalled due to risks of early loosening or increased wear caused by suboptimal implant positioning or inadequate cementing. Manufacturers are providing updated surgical guidance.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1542-2023·2023-05-10

    Knee Implant System Recalled for Risk of Aseptic Loosening

    Linkbio Corp. recalls the LINK SLED Knee System due to risk of aseptic loosening from improper positioning or cementing technique, potentially requiring revision surgery. Five units affected in US and international distribution.

    Product
    LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1541-2023·2023-05-10

    LINK SLED Knee System implants recalled for early loosening risk

    Linkbio Corp. recalls 7 LINK SLED knee implants due to risk of early aseptic loosening and increased wear caused by suboptimal surgical technique. Affected units may require earlier-than-expected revision surgery.

    Product
    LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0562-2023·2023-05-10

    Seatex Alcohol Antiseptic 80% Hand Sanitizer Recalled for Superpotency and Impurities

    Seatex Alcohol Antiseptic 80% (1-gallon containers) is being recalled because the formula does not meet specifications, with superpotency and impurities present. The recall affects lot 220888 distributed in Florida, Georgia, and Texas.

    Product
    Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Container, UPC 6 12592 01480 0 Seatex, LLC. 445 TX Hwy 36 Rosenberg, TX 77471.
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-1549-2023·2023-05-10

    LINK SLED Knee System recalls due to implant loosening risk

    Linkbio Corp. is recalling LINK SLED Knee System implants that may loosen prematurely due to improper positioning or cementing technique. Enhanced surgical training is being provided to prevent early device failure.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1539-2023·2023-05-10

    Orthopedic knee implant system recalled due to early loosening risk

    Linkbio Corp. is recalling 5 units of the LINK SLED Knee System due to risk of early aseptic loosening or increased wear that could require earlier surgical revision. The recall addresses training and surgical technique to prevent implant failure.

    Product
    LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0801-2023·2023-05-10

    Cargill Grain Product Recalled for Gluten Contamination Despite Gluten-Free Label

    Cargill is recalling PROSANTE TVGPTN products labeled as gluten-free because they may contain gluten levels above 20 ppm. The recall affects 42,400 pounds distributed nationwide and internationally.

    Product
    PROSANTE TVGPTN 10P MNCD 25LB BG/32P, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1533-2023·2023-05-10

    LINK SLED Knee System Recalled for Aseptic Loosening and Implant Wear

    Linkbio Corp. is recalling 12 units of the LINK SLED Knee System due to risk of implant loosening and wear that could require revision surgery sooner than expected.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2030/10
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1525-2023·2023-05-10

    LINK SLED Knee Implant Component Recall for Aseptic Loosening Risk

    Linkbio Corp. is recalling the LINK SLED Knee System's all-poly tibial component due to risk of early aseptic loosening and increased wear from suboptimal implant positioning or inadequate cementing during surgery.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0770-2023·2023-05-10

    Dark Chocolate Covered Cashews Recalled for Undeclared Peanut Allergen

    Cargill Cocoa & Chocolate recalled 17 bags of Wilbur Dark Chocolate Covered Cashews due to undeclared peanut allergen. The product was distributed to 6 consumers in Minnesota, New Jersey, Ohio, Florida, Rhode Island, and Kansas.

    Product
    Wilbur¿ Dark Chocolate Covered Cashews Net Wt.16 oz (1 LB) 454g Packaged in plastic bag
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1538-2023·2023-05-10

    LINK SLED Knee Implant Component Recalled for Aseptic Loosening Risk

    The LINK SLED Knee System tibial component is being recalled due to risk of aseptic loosening caused by improper implant positioning or cementing technique, which could lead to early implant failure requiring revision surgery.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2030/15
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1551-2023·2023-05-10

    Knee Implant Component Recalled for Risk of Early Aseptic Loosening

    Linkbio Corp. is recalling the LINK SLED Knee System tibial component due to risk of early aseptic loosening and increased wear caused by suboptimal implant positioning or inadequate cementing technique.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2230/12
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0812-2023·2023-05-10

    PreProtein Dietary Supplement Bottles Recalled for Packaging Defect

    Novis PR, LLC is recalling PreProtein liquid dietary supplement bottles due to bloated packaging. The product was distributed domestically in 16 oz bottles.

    Product
    PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 16 oz Bottle, packed in 12 units of 16 oz. each per case.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0566-2023·2023-05-10

    Advil Liqui-Gels 200 mg ibuprofen capsules recalled for improper storage

    Family Dollar Stores is recalling Advil Liqui-Gels 200 mg ibuprofen capsules (SKUs 0999841 and 0916071) distributed nationwide due to storage outside labeled temperature requirements.

    Product
    Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b) 40-count Liquid Filled Capsule bottles.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1474-2023·2023-05-10

    SafeLight Fiber Optic Cable Recall Due to Assembly Defect

    Stryker Corporation is recalling SafeLight Fiber Optic Cables due to insufficient epoxy on the proximal end, which can cause light output failure and potentially delay surgical procedures.

    Product
    SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1532-2023·2023-05-10

    LINK SLED Knee System Tibial Component Recall Due to Early Loosening Risk

    Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early aseptic loosening and increased wear from improper implant positioning or inadequate cementing. Patients may require revision surgery earlier than expected.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1536-2023·2023-05-10

    Knee Implant System Recalled for Premature Loosening and Wear Risk

    Linkbio Corp. is recalling LINK SLED Knee System implants that may loosen or wear prematurely due to improper surgical positioning or cementing, potentially requiring revision surgery. Updated surgical technique guidance is being provided.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1524-2023·2023-05-10

    LINK SLED Knee System tibial component subject to early loosening recall

    Linkbio Corp. is recalling the LINK SLED Knee System tibial component (15 units) due to risk of early loosening and increased wear from inadequate surgical technique, potentially requiring earlier-than-expected revision surgery.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-2028/14
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0810-2023·2023-05-10

    Dietary Supplement Protein Bottles Recalled for Bloated Packaging

    Novis PR is recalling GPre Protein dietary supplement (lot 230118) due to bloated bottles affecting 6,034 units distributed domestically.

    Product
    GPre Protein, Liquid predigested Protein, Dietary Supplement, Nt Wt. 16 oz, plastic bottle packed 12 units of 16 oz in 1 case.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1559-2023·2023-05-10

    Laboratory automation module firmware may cause sample misidentification

    A firmware bug in Inpeco laboratory automation modules may cause sample misidentification, leading to incorrect electrolyte test results and potential treatment errors.

    Product
    Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1509-2023·2023-05-10

    LINK SLED Knee Prosthesis Recalled for Risk of Premature Failure

    Linkbio Corp. is recalling LINK SLED Knee System prostheses due to risk of early aseptic loosening or increased wear caused by suboptimal surgical technique. The company is providing amended surgical guidelines and training.

    Product
    LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2020/52
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1521-2023·2023-05-10

    Linkbio Knee Implant Recalled for Aseptic Loosening Risk

    Linkbio Corp. is recalling 15 LINK SLED Knee System implants due to risk of aseptic loosening and wear from improper surgical technique. The company is providing amended surgical guidance and training to prevent implant failure.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0800-2023·2023-05-10

    Cargill Recalls PROSANTE Products That May Contain Gluten

    Cargill recalled PROSANTE TVGPTN products labeled gluten-free because they may contain gluten above 20 ppm. About 2.4 million lbs were distributed nationwide and internationally.

    Product
    PROSANTE TVGPTN 12BF MNCD 50LB BG/36P, paper bag
    Category
    Food
    Distribution
    Distributed nationwide