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.

8351–8375 of 52968

  • HighFDA (Devices)·Z-2161-2024·2024-06-26

    Xstar Safety Slit Knife Recalled for Incorrect Blade Bevel Orientation

    Beaver Visitec International is recalling the Xstar Safety Slit Knife Model 378227 because some units have the blade bevel installed incorrectly—facing downward instead of the intended upward orientation.

    Product
    Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1386-2024·2024-06-26

    Milk Chocolate Wafer recalled for potential Salmonella contamination

    Clasen Quality Chocolate Inc. is recalling Milk Chocolate Wafer (Item #51407) distributed in nine states due to potential Salmonella contamination.

    Product
    Milk Chocolate Wafer, Item # 51407 (R&D Sample).
    Category
    Food
    Distribution
    9 states
  • HighNHTSA·24V478000·2024-06-26

    Thomas Built Buses Recall School Buses for Emergency Alarm Defect

    Daimler Trucks North America is recalling 162 Thomas Built Buses Saf-T-Liner C2 and C2 Jouley school buses because the emergency exit alarm may not sound.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2, SAF-T-LINER C2 JOULEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1383-2024·2024-06-26

    Milk Chocolate Coating Recalled for Potential Salmonella Contamination

    Clasen Quality Chocolate Inc. is recalling Milk Chocolate Flavored IC Coating distributed in nine states due to potential Salmonella contamination. The product is sold in bulk tanker format for use in food manufacturing.

    Product
    1057556 Milk Chocolate Flavored IC Coating, Item # 56546. Bulk tanker.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1385-2024·2024-06-26

    Milk Chocolate Confectionery Coating Recalled for Potential Salmonella

    Clasen Quality Chocolate Inc. is recalling Milk Chocolate Flavored Confectionery Coating Bulk (Item #60692) due to potential Salmonella contamination. The product was distributed across nine U.S. states.

    Product
    Milk Chocolate Flavored Confectionery Coating Bulk (MB), Item # 60692.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1381-2024·2024-06-26

    White Chocolate Wafer Recalled for Potential Salmonella Contamination

    Clasen Quality Chocolate Inc. is recalling 74,050 pounds of White Chocolate Wafer due to potential Salmonella contamination. The product was distributed to food service and ingredient suppliers across nine states.

    Product
    White Chocolate Wafer, Item # 59152. Net Wt. 50 lbs (22.68kg). Clasen Quality Chocolate 5126 West Terrace Drive, Madison, WI 53718
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2157-2024·2024-06-26

    OPTETRAK Inset Patella knee implants recalled for improper vacuum packaging

    Exactech is recalling OPTETRAK Inset Patella knee implants packaged in out-of-specification vacuum bags that may compromise product integrity during storage or sterilization.

    Product
    OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1382-2024·2024-06-26

    Clasen Quality Chocolate White Confectionery Wafers Recalled for Salmonella

    Clasen Quality Chocolate is recalling NGMO White Confectionery Wafer due to potential Salmonella contamination. The product was distributed across nine states.

    Product
    NGMO White Confectionery Wafer, Item # 60975. Net Wt. 25 lbs (11.34kg). Clasen Quality Chocolate 5126 West Terrace Drive, Madison, WI 53718
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2152-2024·2024-06-26

    Storage Case Design Flaw May Allow Reuse of Single-Use Surgical Instruments

    Howmedica Osteonics Corp. is recalling HRIS Storage & Sterilization Cases (Part 6210-9-900) due to a design flaw that may allow reuse and resterilization of single-use, sterile instruments. This poses a contamination and infection risk.

    Product
    HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1380-2024·2024-06-26

    Milk Chocolate Flavored Confectionery Coating Recalled for Potential Salmonella

    Clasen Quality Chocolate Inc. is recalling Milk Chocolate Flavored Confectionery Coating (Item #58710) due to potential Salmonella contamination. The bulk tanker product was distributed across nine states.

    Product
    Milk Chocolate Flavored Confectionery Coating (MB), Item #: 58710. Bulk tanker.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-0555-2024·2024-06-26

    FDA Recalls Dexamethasone Sodium Phosphate Injection Due to Impurity Specification Failure

    Eugia US LLC recalls 70,125 vials of Dexamethasone Sodium Phosphate injection due to failed impurity specifications. Testing found sulfonic acid adduct of dexamethasone phosphate exceeded allowed limits.

    Product
    DEXAMETHASONE SODIUM PHOSPHATE — DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2151-2024·2024-06-26

    Hospital bed mattress covers may delaminate from improper cleaning

    Baxter Healthcare is recalling Centrella Max and Pro+ hospital bed mattresses that may develop delaminated top covers when cleaned with bleach-containing solutions. The mattresses prevent and treat pressure injuries.

    Product
    Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.Multiple model numbers of Centrella Max mattresses and pro+ mattresses. (1) Centrella Max Surface, REF P7922A01; (2) C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2155-2024·2024-06-26

    Exactech Knee Patella Components Recalled Due to Out-of-Specification Vacuum Bags

    Exactech is recalling OPTETRAK Three Peg Patella knee components packaged in out-of-specification vacuum bags. The affected products were distributed worldwide.

    Product
    OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2162-2024·2024-06-26

    Xstar Safety Slit Knife Recalled for Incorrect Blade Configuration

    Beaver Visitec International is recalling 126 Xstar Safety Slit Knives with incorrect blade configuration. The recalled knives have the bevel oriented to the back instead of the front.

    Product
    Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2150-2024·2024-06-26

    TabloCart power cord connector may overheat in hemodialysis system

    Outset Medical is recalling 431 TabloCart hemodialysis system carts due to power cord connector defects that may cause overheating, sparks, and smoke, potentially delaying treatment or causing burns.

    Product
    TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used with the Tablo Hemodialysis System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2154-2024·2024-06-26

    Bard Foley Catheter Trays Recalled for Temperature Display Malfunction

    C.R. Bard Inc is recalling 6,420 Foley catheter trays nationwide because some devices may not display temperature readings or may display erratic readings. The malfunction could affect patient monitoring.

    Product
    Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 350 ml Urine Meter, 16 Fr, Catalog #319416AM. Intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2149-2024·2024-06-26

    Ethicon MONOCRYL Plus Sutures Recalled for Packaging Defect

    Ethicon recalled 287,892 MONOCRYL Plus Antibacterial Sutures worldwide due to a packaging machine defect that created holes in primary packaging, potentially compromising sterility and risking infection.

    Product
    MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MCP3200H16 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14 M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2160-2024·2024-06-26

    NxStage PureFlow-B Hemodialysis Solution Bags Recalled Due to Bursting Chambers and Caustic Fluid

    NxStage PureFlow-B hemodialysis solution bags may burst during preparation, releasing caustic electrolyte fluid that can cause chemical burns. Affected units are distributed nationwide.

    Product
    NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2158-2024·2024-06-26

    Exactech OPTETRAK Knee Implants Recalled for Out-of-Specification Vacuum Bag Packaging

    Exactech is recalling OPTETRAK Advanced Patella knee implant components packaged in vacuum bags that did not meet manufacturing specifications. Improper packaging could compromise product sterility.

    Product
    OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1378-2024·2024-06-26

    Milk Chocolate Confectionery Drops Recalled for Potential Salmonella Contamination

    Clasen Quality Chocolate is recalling 18,800 lbs of milk chocolate confectionery drops due to potential Salmonella contamination. The product was distributed across nine states.

    Product
    1085343 10M Milk Chocolate Flavored Confectionery Drop (MB), Item #: 56074. Net Wt. 25lbs (11.34kg). Distributed by: Clasen Quality Chocolate 5126 West Terrace Drive, Madison, WI 53718. Chocolate Coating products.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1387-2024·2024-06-26

    Caramel Confectionery Drops Recalled for Potential Salmonella Contamination

    Clasen Quality Chocolate Inc. is recalling 4M Caramel Flavored Confectionery Drop due to potential Salmonella contamination. The product was distributed to nine states.

    Product
    4M Caramel Flavored Confectionery Drop, Item # 61661 (R&D Sample).
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1379-2024·2024-06-26

    Snow White Chocolate Bulk Product Recalled for Potential Salmonella

    Clasen Quality Chocolate Inc. is recalling Snow White Chocolate bulk tanker product due to potential Salmonella contamination. The product was distributed across multiple states.

    Product
    Snow White Chocolate, Item #: 60949. Bulk tanker.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1377-2024·2024-06-26

    Heinen's Tuscan Salad Bowl recalled for undeclared pecan allergen

    Heinen's Tuscan Salad Bowl is recalled due to the presence of undeclared pecans, a known allergen not listed on the label. Consumers with pecan allergies face a risk of allergic reaction.

    Product
    Heinen's Tuscan Salad Bowl Ingredients: Garbanzo Beans***Disodium EDTA***Arugula, Roasted Corn***Red Bell Pepper, Dried Cranberries***Walnuts***Parmesan Cheese*** Contains: WALNUT, MILK
    Category
    Food
    Distribution
    2 states