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.

13401–13425 of 53086

  • HighFDA (Food)·F-0782-2023·2023-05-10

    Gluten-Free Flour Product May Contain Excess Gluten, Nationwide Recall

    Cargill's PROSANTE brand flour products labeled gluten-free may contain gluten above 20 ppm. The products were distributed nationwide across the US and internationally.

    Product
    PROSANTE TVGPTN 3014B FLK 50LB BG, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0564-2023·2023-05-10

    Advil Ibuprofen 200mg tablets recalled due to improper storage conditions

    Family Dollar Stores is recalling Advil Ibuprofen 200mg caplets stored outside temperature requirements. The recall affects units distributed nationwide from July 2022 through March 2023.

    Product
    Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1511-2023·2023-05-10

    Knee implant tibial component recalled for aseptic loosening risk

    Linkbio Corp. recalls LINK SLED Knee System tibial component due to risks of early aseptic loosening and implant wear from improper surgical positioning or cementing technique.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1560-2023·2023-05-10

    Laboratory Automation System Firmware May Misassociate Patient Samples

    Inpeco laboratory automation systems have a firmware defect that may cause sample ID mis-association, leading to incorrect test results for electrolyte measurements. Potential consequences include abnormal treatment decisions and serious health complications.

    Product
    Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-207-01, ACP-230-00, ACP-230-01 APT-207-00, APT-207-01, APT-230-00, APT-230-01…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2023·2023-05-10

    Knee Implant Recall for Aseptic Loosening and Implant Wear Risk

    The LINK SLED Knee System is recalled due to risk of early aseptic loosening and implant wear caused by suboptimal surgical positioning or inadequate cementing. The manufacturer is updating surgical guidance and providing additional training.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1530-2023·2023-05-10

    LINK SLED Knee Implant Recall: Risk of Early Loosening and Revision Surgery

    Linkbio Corp. is recalling 14 LINK SLED Knee implants due to risk of aseptic loosening and increased wear caused by improper surgical technique. The implants may fail earlier than expected, requiring revision surgery.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0809-2023·2023-05-10

    Atkins Dark Chocolate Royale Protein Shakes Recalled for Contamination

    Simply Good Foods Co. is recalling Atkins Dark Chocolate Royale Protein Rich Shakes due to contamination that rendered the product non-sterile, creating potential for spoilage.

    Product
    Atkins Dark Chocolate Royale Protein Rich Shakes, NET WT. 44 oz (4 / 11oz) 4 Tetra packs per carton, UPC 637480065108, Distributed exclusively by Simply Good Foods USA, Inc. 1 Denver, CO 80202 1-800-6-ATKINS.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1554-2023·2023-05-10

    LINK SLED Knee System tibial implant recalled for aseptic loosening

    Linkbio Corp. recalls LINK SLED Knee System tibial component due to risk of aseptic loosening and implant wear from improper surgical technique, potentially requiring revision surgery.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1548-2023·2023-05-10

    LINK SLED knee implant system surgical technique amendment for aseptic loosening prevention

    Linkbio Corp. is updating surgical technique guidance for the LINK SLED knee implant system to prevent early aseptic loosening or implant wear caused by suboptimal positioning or cementing technique during surgery.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1540-2023·2023-05-10

    LINK SLED Knee System recalls issued over aseptic loosening risk

    Linkbio Corp. is recalling LINK SLED Knee System knee components due to risk of early aseptic loosening or increased wear. The company is issuing updated surgical technique guidance to address suboptimal implant positioning and cementing techniques.

    Product
    LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1513-2023·2023-05-10

    Knee Implant System Component Recalled Due to Aseptic Loosening Risk

    Linkbio Corp. is recalling 13 units of the LINK SLED Knee System tibial component due to risk of aseptic loosening and increased wear. These risks arise from improper surgical positioning or inadequate cementing technique during implantation.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1501-2023·2023-05-10

    Medical Image Viewer May Mismatch Patient Study Records

    GE Healthcare's Centricity Universal Viewer can mismatch patient information when correcting patient or study data, affecting 329 units distributed worldwide.

    Product
    Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 2088026-043, e) 2088026-044, f) 2088026-115, g) 2088026-132, h) 2088026-306, i) 2088026-308, j) 2088026-406, k) 2088026-506, l)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1510-2023·2023-05-10

    LINK SLED knee implant system recalled for inadequate surgical technique

    Linkbio Corp. is amending training for the LINK SLED Knee System due to early implant loosening and wear caused by inadequate surgical positioning and cementing techniques. Healthcare providers should implement updated surgical guidance.

    Product
    LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1535-2023·2023-05-10

    Knee Implant Recalled for Inadequate Surgical Technique Guidance

    Linkbio is recalling 15 LINK SLED Knee Systems due to potential aseptic loosening and wear from suboptimal implant positioning or inadequate cementing during surgery. Updated surgical technique training is required.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2030/12
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1526-2023·2023-05-10

    LINK SLED Knee Implant System recalled for early aseptic loosening

    The LINK SLED Knee System ALL POLY TIBIAL COMPONENT (18 units) is recalled due to early aseptic loosening and increased wear caused by suboptimal positioning or inadequate cementing technique, which may require earlier-than-expected revision surgery.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0781-2023·2023-05-10

    Prolia soy flour products recalled for undisclosed gluten content

    Cargill is recalling multiple PROLIA soy flour products that carry gluten-free claims but may contain gluten above 20 ppm. Consumers with celiac disease or gluten sensitivity should not consume affected products.

    Product
    PROLIA SOY FLR 200/20 STD BLK, PROLIA SOY FLR 200/70 STD BLK, PROLIA SOY FLR 300/70 NT BLK, PROLIA SOY FLR 100/20 STD 1MT TT, PROLIA SOY FLR 100/90 STD 1500LB TT, PROLIA SOY FLR 100/90 NT 50LB BG, PROLIA SOY FLR 200/20 XTRA 50LB BG NGM, PROLIA SOY FLR 200/20 STD 50LB BG, PROLIA…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1504-2023·2023-05-10

    Siemens Atellica cortisol kits recalled for negative bias in urine testing

    Siemens Healthcare Diagnostics recalls 34,746 Atellica IM Cortisol diagnostic kits due to negative bias in urine test results, which may produce inaccurately low cortisol measurements.

    Product
    Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1563-2023·2023-05-10

    Laboratory automation system firmware recalled for sample mis-identification

    Inpeco is recalling Alinity h laboratory automation system firmware that may mis-identify samples, causing incorrect electrolyte test results that could lead to improper patient treatment.

    Product
    Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1502-2023·2023-05-10

    Radiological imaging system may mismatch patient records

    GE Healthcare's Centricity PACS-IW radiological system can mismatch information between patients when correcting patient or study data. No illnesses reported.

    Product
    Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g) 2052829-001, h) Not applicable; Radiological Image Processing System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0793-2023·2023-05-10

    Soy Flour Recalled for Undisclosed Gluten Levels

    Cargill is recalling PROSANTE TSOYFLR soy flour labeled as gluten-free that may contain gluten exceeding safe limits (20 ppm). The product was distributed nationwide and internationally.

    Product
    PROSANTE TSOYFLR 12P MNCD 50LB BG/36P, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0791-2023·2023-05-10

    Cargill Gluten-Free Product Recall Due to Gluten Content

    Cargill is recalling approximately 110,650 pounds of PROSANTE TVGPTN 12B products labeled as gluten-free because they may contain gluten above the safe threshold.

    Product
    PROSANTE TVGPTN 12B MNCD 50LB BG, PROSANTE TVGPTN 12B MNCD 50LB BG 21/P, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1534-2023·2023-05-10

    Knee implant system recalled due to risk of aseptic loosening

    The LINK SLED Knee System has been recalled due to risk of early aseptic loosening and wear caused by suboptimal implant positioning or inadequate cementing technique during surgery.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1531-2023·2023-05-10

    LINK SLED Knee Implant Recall Due to Loosening and Wear Risks

    Linkbio Corp. is recalling 14 units of LINK SLED Knee System implants due to risk of early aseptic loosening or wear from suboptimal positioning or inadequate cementing. Updated surgical technique training is being issued.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1522-2023·2023-05-10

    Knee Implant Component Recalled for Aseptic Loosening Risk

    Linkbio Corp. recalls 14 units of the LINK SLED Knee System tibial component due to risk of early aseptic loosening and increased wear from suboptimal implant positioning or inadequate cementing technique. Healthcare providers should follow updated surgical guidance.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15-2028/12
    Category
    Medical Device
    Distribution
    2 states