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.

19151–19175 of 50410

  • HighFDA (Food)·F-0987-2021·2021-09-29

    Joy Tamarind Chutney Recalled for Undeclared Sulfites

    Joy Gourmet Foods LLC is recalling Joy Tamarind Chutney (8 oz, best by 09/30/22) because it contains high levels of undeclared sulfites, which can pose a serious health risk to sensitive individuals.

    Product
    1. "***JOY***Tamarind Chutney***NET WT 8 OZ (228g)***06.19 BEST BY 093022***INGREDIENTS: TAMARIND TOMATOES, SALT, SPICES, SUGAR, STABILIZERS (GUAR, TRAGAGANTH AND XANTHAN), CITIRC ACID, SODIUM BENZOATE AS PRESERVATIVE.***Distributed by: Joy Gourmet Foods LLC.***48-80 Maspeth…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2504-2021·2021-09-29

    DLP Left Heart Vent Catheters recalled due to potential wire protrusion

    Medtronic is recalling 51,494 DLP Left Heart Vent Catheters due to potential wire protrusion through the catheter tip. This defect could compromise proper device function during use.

    Product
    DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2493-2021·2021-09-29

    General Manual Surgical Instruments Recalled Due to Compromised Sterility Assurance

    M.D.L. S.r.l. is recalling approximately 4,120 units of general manual surgical instruments nationwide due to compromised sterility assurance. Healthcare facilities should verify lot numbers and quarantine affected instruments immediately.

    Product
    General Manual surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2021·2021-09-29

    C.R. Bard Foley Catheter Trays Recalled for Sterile Packaging Defects

    C.R. Bard is recalling 3,980 units of Foley catheter supply kits due to potential packaging defects that may compromise the sterile barrier. No illnesses have been reported.

    Product
    Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2538-2021·2021-09-29

    C.R. Bard Foley Catheter Tray Recalled for Packaging Defects

    C.R. Bard is recalling a Foley catheter tray system due to packaging defects that may compromise the sterile barrier. The recall affects 8,170 units distributed nationwide.

    Product
    Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2510-2021·2021-09-29

    Aesculap Univation X System knee implant devices recalled for potential loosening

    Aesculap is recalling Univation X System knee implants nationwide because they may loosen, potentially requiring revision surgery.

    Product
    Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NL477 UNIVATION F MENISCAL COMP.T2 RM/LM 8MM; NL478 UNIVATION F MENISCAL COMP.T3 RM/LM 8MM; NL479 UNIVATION F MENISCAL COMP.T4 RM/LM 8MM; NL480 UNIVATION F…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2522-2021·2021-09-29

    Foley Catheter Drainage Tray System Packaging Defect Recall

    C.R. Bard Inc is recalling a Foley catheter tray system due to potential packaging defects that may compromise the sterile barrier, affecting 1,760 units distributed nationwide.

    Product
    Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1015-2021·2021-09-29

    Lemon Blueberry Scones Recalled for Undeclared Milk Allergen

    Baker's Corner Bakery is recalling Lemon Blueberry Scones because milk is not declared in the "Contains" statement, even though butter and buttermilk are listed in the ingredients. Consumers with milk allergies may be at risk.

    Product
    Lemon Blueberry Scones, packed in closed box, net wt. 12 oz. The label of affected product is read in parts: "*** Lemon Blueberry Scones*** Ingredients: Shepherds Grain Flour (wheat our, malted barley our, niacin, reduced iron, thiamine, mononitrate, ribo avin, folic acid)…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2534-2021·2021-09-29

    C.R. Bard Foley Catheter Kits Recalled for Potential Sterile Barrier Defects

    C.R. Bard is recalling 960 units of Foley Tray catheter kits (lot NGFR0101) due to potential packaging defects that may compromise the sterile barrier.

    Product
    Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0986-2021·2021-09-29

    Dickies Seafood Cooked & Spiced Shrimp Recalled for Undeclared Sulfites

    SSPI Mid-Atlantic, Inc. is recalling Dickies Seafood Cooked & Spiced Shrimp products because they contain undeclared sulfites, an allergen that may not be listed on the label.

    Product
    1. Dickies Seafood Cooked & Spiced Shrimp (12 oz) UPC 5240700804 Sell by 9/8/2021 & 9/12/2021. Labeled containers 2. Dickies Seafood Cooked & Spiced Shrimp (2.25 LB) UPC 5240700806 Sell by9/8/2021 & 9/12/2021.Labeled containers 3. Dickies Seafood Cooked & Spiced Shrimp (5…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2506-2021·2021-09-29

    CoLink Bone Graft Harvester Recalled for Breaking at Weld Site

    In2bones USA is recalling CoLink Bone Graft Harvesters after reports of the instruments breaking at the outer tube weld site. The recall affects 835 units distributed nationwide across 29 states.

    Product
    CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended for assisting surgeons in the manipulation of bone during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2523-2021·2021-09-29

    C.R. Bard Foley Tray and Drainage Bag Recalled for Packaging Defects

    C.R. Bard is recalling 11,780 Foley Tray units nationwide due to potential packaging defects that may compromise the sterile barrier.

    Product
    Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21204·2021-09-29

    Luyuan Youth ATVs Recalled for Crash Hazard and Safety Standard Violation

    Luyuan Inc. is recalling about 6,800 youth all-terrain vehicles sold from August 2018 through August 2020 because they fail to comply with federal ATV safety standards, including maximum speed limitations required for children under 10.

    Product
    Luyuan Youth All-Terrain Vehicles (ATVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2503-2021·2021-09-29

    GE Healthcare Medical Imaging Software Recall: Image Acquisition and Archive Synchronization Failures

    GE Healthcare is recalling Centricity Universal Viewer and Viewer 6.0 software due to image acquisition and synchronization failures with the Centricity Enterprise Archive that could impact diagnostic data integrity.

    Product
    Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Includes the following Model Numbers: 1. Model Number: 2090255-001; 2. Model Number: 2088026-723; 3. Model…
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2505-2021·2021-09-29

    DLP Left Heart Vent Catheters Recalled for Potential Wire Protrusion

    Medtronic recalls DLP Left Heart Vent Catheters due to risk of wire protrusion through the catheter tip. The defect could cause internal injury during cardiac procedures.

    Product
    DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2524-2021·2021-09-29

    C.R. Bard Foley Catheter Kit Recall: Packaging Sterility Defect

    C.R. Bard is recalling Foley catheter kits due to packaging defects that may compromise the sterile barrier. No illnesses have been reported.

    Product
    Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0991-2021·2021-09-29

    Carrot Cake Recall: Undeclared Milk, Coconut, Walnut Allergens

    The Baking Institute Baking Co. is recalling carrot cakes sold in the Chicago area because they contain undeclared milk, coconut, and walnuts. The products pose a serious risk to consumers with allergies to these ingredients.

    Product
    Carrot cake (no brand), 6 inch and 8 inch sizes, on plastic base, with clear plastic dome. UPC code: 8 13749 01001 4 6-inch cake 8 50024 83623 5 8-inch cake
    Category
    Food
    Distribution
    1 state
  • HighCPSC·21201·2021-09-29

    Kohl's Recalls SONOMA Oversized Antigravity Chairs Due to Fall Hazard

    Kohl's is recalling about 31,000 SONOMA Goods For Life-branded Ultimate Oversized Antigravity Chairs because the aluminum frame can break or collapse under weight, creating a fall hazard. The company has received 18 reports of breakage or collapse, including two reports of minor injuries.

    Product
    SONOMA Goods For Life Branded Ultimate Oversized Antigravity Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2541-2021·2021-09-29

    C.R. Bard Foley Tray Recalled for Potential Sterile Barrier Packaging Defects

    C.R. Bard Inc is recalling Foley Tray kits nationwide due to potential packaging defects that may compromise the sterile barrier. The product was distributed throughout the United States.

    Product
    Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1007-2021·2021-09-29

    Daniele Plain Breadsticks Recall for Undeclared Sesame

    JAG Specialty Foods is recalling Daniele Plain Bulk breadsticks because the product may contain undeclared sesame seeds, which poses a risk to consumers with sesame allergies.

    Product
    Daniele - PLAIN BULK (28 LB.); Plain Breadsticks; Case Pack 4/7lb bags; Item #1383; PLAIN: UNBLEACHED ENRICHED WHEAT FLOUR (CONTAINS MALTED BARLEY FLOUR, NIACIN, REDUCED IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID), SOYBEAL OIL, YEAST, SALT, CORN AND MALT SYRUP.…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2508-2021·2021-09-29

    COVID-19 antibody test assay recalled due to insufficient validation evidence

    Beckman Coulter is recalling Access SARS-CoV-2 IgG test kits nationwide due to insufficient evidence in the FDA authorization submission. The test validation may be inadequate for accurate COVID-19 antibody detection.

    Product
    Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2489-2021·2021-09-29

    Bone Marrow Biopsy Needles Recalled for Sterility Assurance Concerns

    M.D.L. S.r.l. is recalling approximately 21,518 bone marrow biopsy needles distributed nationwide because sterility assurance may be compromised.

    Product
    Bone Marrow Transplantation biopsy needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V759000·2021-09-29

    GM Recalls 2016-2017 Cadillac CT6 for Excessively Bright Park Lights

    General Motors is recalling 2016-2017 Cadillac CT6 vehicles because the park/position lights may be excessively bright, potentially affecting other drivers' vision and increasing crash risk.

    Product
    CADILLAC — CADILLAC CT6
    Category
    Vehicle
    Distribution
    Distributed nationwide