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.

4301–4325 of 52939

  • HighFDA (Devices)·Z-1956-2025·2025-06-18

    Contact Lens Insertion Solution Recalled for Potential Sterility Defect

    Contamac Nutrifill Physiologic formula contact lens insertion solution is being recalled because it may lack sterility. The affected product was distributed nationwide.

    Product
    Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1922-2025·2025-06-18

    Soltive SuperPulsed Laser Fibers recalled for thermal incident risk

    Olympus Corporation of the Americas is recalling Soltive SuperPulsed Laser Fibers due to potential fiber fracturing that can cause thermal incidents including smoke, sparks, burning, or unsteady flames during clinical use.

    Product
    Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TLF-FBX940S, TFL-FBX150BS-JA (Japan Only), TFL-FBX550S-JA (Japan Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1927-2025·2025-06-18

    EPIONE Stereotactic Device Software Bug Poses Instrument Guidance Risk

    The EPIONE Model 30-0001 stereotactic device is recalled due to a software bug that may cause the robotic arm to incorrectly guide surgical instruments during CT-guided ablation procedures. Four units have been distributed in the U.S.

    Product
    EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0937-2025·2025-06-18

    Taylor Shellfish Farms Geoduck Chowder Base Recall for Undeclared Anchovies

    Vern's Foods & Farm is recalling Taylor Shellfish Farms Geoduck Chowder Base because the product contains anchovies that are not declared on the label, creating a risk for people with fish allergies.

    Product
    Taylor Shellfish Farms Geoduck Chowder Base, frozen, Ingredients: Potatoes, Clam (Geoduck) ***Butter (Cream, Salt), Fish Sauce Ka Me***CONTAINS: MILK, CLAMS. Product is packed in rigid plastic tubs. Net wt. 16 oz. Produced with local, farm fresh ingredients by: Vern's Foods &
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1970-2025·2025-06-18

    Alaris Pump Infusion Sets may leak at male luer connections

    BD Switzerland is recalling multiple Alaris Pump Infusion Set models worldwide due to potential leaks at the connection between the closed male luer component and needle-free connector, which could delay procedures, interrupt treatment, expose patients to hazardous drugs, or result in underdosing.

    Product
    Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1939-2025·2025-06-18

    Femoral Nail T2 GTN Left and Right Versions Mislabeled

    Stryker GmbH is recalling certain Femoral Nail T2 GTN devices because some labeled as left version contained right nails, and vice versa. This mislabeling could result in incorrect surgical implantation.

    Product
    Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1954-2025·2025-06-18

    Tecfen Medical 2.0mm Crescent Knife Ophthalmic Device Recall

    Tecfen Medical is recalling 2.0mm Crescent Knife ophthalmic surgical instruments (Model QKN1010, Lot ZGY24071501-03) due to sterility assurance concerns. The affected devices were distributed in the US and internationally.

    Product
    Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyhvek 1059B. The crescent kn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1940-2025·2025-06-18

    Femoral Nail RIGHT T2 GTN 8x300 mm labeled incorrectly

    Stryker GmbH is recalling Femoral Nail RIGHT T2 GTN 8x300 mm devices because some lots were labeled as left or right but contained the opposite orientation.

    Product
    Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1955-2025·2025-06-18

    Tecfen Medical 3.2mm Slit Knife Angled Ophthalmic Knife Sterility Recall

    Tecfen Medical is recalling the 3.2mm Slit Knife, Angled model QKN3261 due to sterility assurance concerns. The recall affects units distributed nationwide in Connecticut and Minnesota as well as internationally.

    Product
    Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyvek 1059B. Slit knives are used to crea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0019-2025·2025-06-18

    Sysco fresh salad products recalled for potential Salmonella contamination

    Sysco Corporation is recalling multiple fresh salad products because cucumbers used in the products have the potential to be contaminated with Salmonella. The recall affects salads sold under brands including East Coast Fresh and Created Fresh.

    Product
    5185 2/7.125# EAST COAST FRESH AUTHENTIC GREEK SALAD (4070 2/7.125# ALL LOT CODES HKSAL138 1/8 OZ. EA JACK AND OLIVE Salad- House- JO ALL LOT CODES HKSAL176 6/8 OZ. CS CREATED FRESH Salad- House- 6/8oz ALL LOT CODES HKSAL43 2/ 5 LB. CS CREATED FRESH Salad- Kit- Tomato Cucumber 2
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-1950-2025·2025-06-18

    Tecfen Medical 2.2mm Slit Knife ophthalmic device sterility recall

    Tecfen Medical is recalling its 2.2mm Slit Knife (Model QKN2261) due to sterility assurance concerns. The ophthalmic knife is used to create precise incisions for eye surgery.

    Product
    Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1923-2025·2025-06-18

    Soltive Reusable Laser Fibers Recalled for Thermal Incident Risk

    Olympus Corporation of the Americas is recalling Soltive Reusable Laser Fibers due to risk of thermal incidents including smoke, sparks, burning, or unsteady flames during surgery, caused by fiber fracturing.

    Product
    Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan Only), TFL-FBX365R-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150R-J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V398000·2025-06-13

    Ford Recalls 2025 F-150 Trucks Due to Engine Stall Risk

    Ford is recalling 2025 F-150 trucks because the engine coolant hose may chafe the wire harness, causing the engine to stall and increasing crash risk.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V393000·2025-06-13

    Ford Explorer second row seats may unlatch or slide while driving

    Ford is recalling certain 2020-2025 Explorer and Lincoln Aviator vehicles because the easy-entry second-row seat switch may bind, letting seats unlatch, fold or slide unexpectedly.

    Product
    FORD — FORD, LINCOLN EXPLORER, AVIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V344000·2025-06-13

    Ford connecting rods and bearings may have manufacturing defects

    Ford is recalling certain 2025 Transit, F-150 and Explorer vehicles because connecting rod and rod bearing components may have manufacturing defects leading to engine failure.

    Product
    FORD — FORD EXPLORER, F-150, TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V403000·2025-06-13

    Lincoln Navigator side marker and daytime running lights may fail

    Ford is recalling certain 2022 Lincoln Navigator vehicles previously repaired under recall 22V455 because headlight control module software may fail the side marker and daytime running lights.

    Product
    LINCOLN — LINCOLN NAVIGATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V400000·2025-06-13

    Altec Recalls Aerial and Service Trucks Due to Electrical Defect

    Altec is recalling specific aerial and service trucks because a voltage spike may damage a control module, potentially causing a loss of vehicle control or brake performance.

    Product
    ALTEC — ALTEC AT SERIES, LS SERIES, L SERIES AERIAL DEVICE, SERVICE BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25334·2025-06-12

    RYOBI 40V 24-Inch Cordless Hedge Trimmers Recalled for Laceration Hazard

    TI Outdoor Power Equipment is recalling about 113,000 RYOBI 40V 24-inch cordless hedge trimmers because the blade can unexpectedly activate from pressing only one control, causing lacerations. Consumers should stop using the trimmer and return it for a free replacement.

    Product
    RYOBI 40V 24-Inch Cordless Hedge Trimmers
    Category
    Consumer Product
    Distribution
    Distributed nationwide