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.

4276–4300 of 52939

  • HighFDA (Devices)·Z-1973-2025·2025-06-18

    BD TEXIUM Closed Male Luer Drug Transfer Device Recall

    BD TEXIUM Closed Male Luer devices may leak at the interface between the closed male luer component and needle-free connector. The leak could cause procedure delays, treatment interruptions, exposure to hazardous drugs, and underdosing of medication.

    Product
    BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V410000·2025-06-18

    2026 Tesla Model Y and Model 3 Vehicles Seat Fastener Recall

    Tesla is recalling certain 2026 Model Y and Model 3 vehicles because seat back fasteners may have been improperly tightened, potentially affecting proper occupant restraint during a crash.

    Product
    TESLA — TESLA MODEL 3, MODEL Y
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25C008000·2025-06-18

    Evenflo Recalls Titan 65 Child Seats Due to Incorrect Instruction Manuals

    Evenflo is recalling Titan 65 child seats manufactured in early 2025 that may have incorrect instruction manuals, posing a risk of improper installation.

    Product
    EQUIPMENT:OTHER:OWNERS/SERVICE/OTHER MANUAL recall
    Category
    Vehicle
    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 (Devices)·Z-1971-2025·2025-06-18

    BD Texium Needle-Free Syringe Recalled for Potential Leakage at Luer Interface

    BD Texium Needle-Free Syringes (multiple sizes) may leak at the interface between the male luer component and needle-free connector, potentially causing treatment delays, medication underdosing, or exposure to hazardous drugs.

    Product
    BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0931-2025·2025-06-18

    Instant Milk Tea Honeydew Flavor powder lacks milk allergen declaration

    R&M Refresher Instant Milk Tea Honeydew Flavor powder contains milk ingredients (whey powder and sodium caseinate) but does not declare milk on the label, posing an allergen risk to consumers with milk allergies.

    Product
    Instant Milk Tea Honeydew Flavor, R&M Refresher brand, B0D7269JC1, net wt. 1lb. Product was sold in 1-pack or 3-pack. Parent ASIN #B0D728CZWS 1-pack ASIN #B0D7269JC1 3-pack ASIN #B0D726K269 Label declares Ingredients: Non-Dairy Creamer (Glucose Syrup, Vegetable Oil, Whey Powd
    Category
    Food
    Distribution
    Distributed nationwide
  • 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 (Food)·H-0017-2025·2025-06-18

    Rocky Road Ice Cream 1.5 qt with Mislabeled Tree Nut Allergen

    Unilever Manufacturing is recalling Rocky Road Ice Cream due to conflicting allergen labeling—the tub says "may contain tree nuts" while the lid declares almonds are present. Consumers with tree nut allergies may be at risk.

    Product
    Rocky Road Ice Cream packaged in a Breyer Chocolate Truffle Tub that says "may contain tree nuts" with a Breyers Rocky Road Ice Cream Lid that declares almonds as an ingredient. 1.5 qt
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1917-2025·2025-06-18

    SCD Comfort Knee Length sleeves recalled for software logic errors

    Cardinal Health is recalling SCD Comfort Knee Length Small sleeves (SKU 84021) due to incorrect software logic that may cause frequent E1 errors and delay patient treatment.

    Product
    SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·H-0018-2025·2025-06-18

    Sysco Corporation Cucumbers Recalled for Potential Salmonella Contamination

    Sysco Corporation is recalling cucumber products sold under the Imperial Fresh, East Coast Fresh, Just Cut, Wellsley Farms, and other brands due to potential Salmonella contamination. The products were distributed to multiple states and Puerto Rico.

    Product
    3909520 2/5# IMPERIAL FRESH CUCUMBER DICED 3/8 SK-ON ALL LOT CODES 480414 2/5 # IMPERIAL FRESH FC CUCUMBER STRIPED AND SLICED ALL LOT CODES 481768 12/3 OZ IMPERIAL FRESH FC VEG VEGGIE W/HUMMUS SMALL P ALL LOT CODES 511666 2/5 # IMPERIAL FRESH FC CUCUMBER SLICED SKIN ON ALL LOT CO
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-1920-2025·2025-06-18

    SOLTIVE Pro SuperPulsed Laser System surgical instrument thermal incident

    Olympus Corporation of the Americas is recalling the SOLTIVE Pro SuperPulsed Laser System due to risk of unexpected smoke, sparks, burning, or unsteady flames caused by fiber fracturing during clinical use.

    Product
    Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1820-2025·2025-06-18

    OEC Elite and OEC 3D Mobile C-Arms X-ray Field Size Defect

    GE Medical Systems is recalling certain OEC Elite and OEC 3D mobile C-arm imaging systems because some units may produce X-ray fields that exceed acceptable limits, posing a potential radiation safety risk.

    Product
    OEC 3D
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0935-2025·2025-06-18

    Instant Milk Tea Brown Sugar Powder recalled for undeclared milk allergen

    R&M Refresher brand Instant Milk Tea Brown Sugar Flavor is recalled because the ingredients contain milk (Whey Powder, Sodium Caseinate) but the label does not declare milk as an allergen.

    Product
    Instant Milk Tea Brown Sugar Flavor, R&M Refresher brand, B0D725TXQW, net wt. 1lb. Product is sold in 3-pack. Parent ASIN #B0D728CZWS 3-pack ASIN #B0D72FQVDR Ingredients: Non-Dairy Creamer (Glucose Syrup, Vegetable Oil, Whey Powder, Sodium Caseinate***). Product of China. Dis
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2025·2025-06-18

    OEC Elite and OEC 3D Mobile C-Arms X-ray Field Size Exceeds Limit

    GE Medical Systems is recalling certain OEC Elite and OEC 3D mobile C-arm systems that may produce X-ray fields exceeding acceptable limits. Some units also lack proper acceptance limits in their service manuals.

    Product
    OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·25V416000·2025-06-18

    REV Recalls 2025-2026 Fleetwood and Holiday Rambler Motorhomes for Electrical Defect

    REV is recalling 2025-2026 Fleetwood Altitude and Holiday Rambler Incline motorhomes because water intrusion may cause electrical components to fail, potentially disabling carbon monoxide or propane detectors.

    Product
    FLEETWOOD — FLEETWOOD, HOLIDAY RAMBLER ALTITUDE, INCLINE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25341·2025-06-18

    YaFiti White 12-Drawer Dressers Recalled for Tip-Over Entrapment Hazards

    YaFiti 12-Drawer White Dressers pose serious tip-over and entrapment hazards to children if not anchored to the wall, violating federal standards. About 6,000 units sold on Amazon from September 2023 through March 2025.

    Product
    YaFiti 12-Drawer White Dressers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25343·2025-06-18

    Polaris Ranger XP and Pro XD Kinetic ROVs Recalled for Fire Hazard

    Polaris is recalling Model Year 2023-2024 Ranger XP Kinetic and Model Year 2025 Pro XD Kinetic ROVs because water can leak through a cracked filter into the high-voltage charging harness and cause a fire. The company has received 47 reports of filter failures, including six reports of melting or fire.

    Product
    Model Year 2023-2024 Ranger XP Kinetic and Model Year 2025 Pro XD Kinetic ROVs
    Category
    Vehicle
    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
  • HighCPSC·25344·2025-06-18

    Crayan Mattresses Recalled for Fire Hazard Risk

    About 100,000 Crayan Mattresses fail to meet federal flame-resistance standards, posing a fire hazard. Consumers should stop using them immediately and contact Crayan for a refund.

    Product
    Crayan Mattresses
    Category
    Consumer Product
    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 (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-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-1914-2025·2025-06-18

    Stryker Gamma4 Long Nail with incorrect left-nail geometry recalled

    Stryker GmbH is recalling a specific lot of Gamma4 Right Long Nails (Catalog Number 84250320S) because they were manufactured with left-nail geometry instead of right-nail geometry, which could affect surgical fit and function.

    Product
    Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
    Category
    Medical Device
    Distribution
    Distributed nationwide