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.

8151–8175 of 52968

  • HighFDA (Devices)·Z-2289-2024·2024-07-17

    Cast Padding Component Recalled for Excess Ethylene Oxide Residuals

    American Contract Systems Inc is recalling ACL cast padding components due to ethylene oxide/ethylene chlorohydrin residuals exceeding safe limits for permanent skin contact devices. Affected product distributed nationwide.

    Product
    ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2343-2024·2024-07-17

    Blood Pump Rotor Spare Part Recalled for Loose Guide Sheaves

    Fresenius Medical Care is recalling approximately 1,156 blood pump rotor spare parts (Model F40015481 Rev A) distributed in the U.S. and Canada due to reports of loose or dislodged guide sheaves after clinical use.

    Product
    190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2281-2024·2024-07-17

    Arthroscopy Procedure Tray Recalled for Sterilant Residual Contamination

    American Contract Systems Inc is recalling 272 units of the ARTHROSCOPY SUP JOI PACK Procedure Tray because sterilant residuals in the cast padding exceeded safe limits for permanent implant use.

    Product
    ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2299-2024·2024-07-17

    TOTAL KNEE-Procedure Kit Recalled Due to Ethylene Oxide Residuals

    American Contract Systems is recalling 976 units of TOTAL KNEE-Procedure Kits nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed safe exposure limits for medical devices.

    Product
    TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1470-2024·2024-07-17

    C. Kreuger Gluten Free Peanut Butter Cookies recalled for missing ingredient statement

    C. Krueger Finest Baked Goods is recalling C. Kreuger Gluten Free Peanut Butter Cookies due to missing ingredient statement on labels, preventing consumers from identifying allergens. The recall affects 4,538 cookies distributed across all U.S. states.

    Product
    C. Kreuger Gluten Free Peanut Butter Cookies, 2oz in plastic sleeve. 60 cookies per case. Storage for 30 days at ambient and 1 year frozen.
    Category
    Food
    Distribution
    50 states
  • HighFDA (Food)·F-1474-2024·2024-07-17

    Hudson Harvest Tomato Basil Sauce Recalled Due to Under-Processing

    Hudson Harvest Tomato Basil Sauce may be under-processed, creating a potential food safety risk. The recall affects 243 jars with lot #1042426 distributed in New York, Massachusetts, and Connecticut.

    Product
    Hudson Harvest Tomato Basil Sauce, 16 oz., UPC # 683720301567
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2340-2024·2024-07-17

    Blood Pump Rotor for Hemodialysis System Recalled for Loose Components

    Fresenius Medical Care is recalling Blood Pump Rotor components used in hemodialysis systems after reports of loose or dislodged guide sheaves during use. The defect affects 372 units distributed nationwide and in Canada.

    Product
    190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2330-2024·2024-07-17

    Presource Neurological Surgical Kits Recalled for Syringe Design Defect

    Cardinal Health is recalling Presource neurological surgical kits containing defectively designed syringes that may cause inaccurate dosing or device leakage. The recall affects 13,487 kits distributed nationwide.

    Product
    Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number SAN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2328-2024·2024-07-17

    Cardinal Health Cardiac Catheterization Kits Recalled for Potential Syringe Design Defect

    Cardinal Health is recalling Presource Cardiac Catheterization Kits because the included syringes may have design defects that could cause inaccurate dosing or leakage, creating a risk of patient harm.

    Product
    Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB; 2) Cardiac Catheterization Kit, Catalog Number SAN73CCV10; 3) Cardiac Catheterization Kit, Catalog Number SAN73CCV11; 4) Cardiac Catheterization Kit, Catalog Number SAN73CCV1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2302-2024·2024-07-17

    Medical knee procedure kit recalled for excessive sterilization chemical residue

    American Contract Systems Inc is recalling TOTAL KNEE-Procedure Kits due to excessive ethylene oxide and ethylene chlorohydrin residues on the cast padding component. The recall affects 85 units distributed nationwide.

    Product
    TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V530000·2024-07-12

    2024 Forest River travel trailers recalled for incorrect Federal Placard rim size

    Forest River is recalling 2024 Stealth EVO, Salem, and Wildwood travel trailers due to incorrect rim-size information on the Federal Placard. The mislabeling may result in wrong wheels being installed, increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER SALEM, WILDWOOD, STEALTH EVO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24299·2024-07-11

    Claire's and Icing Stores Halloween Witch Hats Burn Hazard Recall

    Claire's and Icing stores are recalling about 5,700 Halloween witch hats sold nationwide from July through December 2023. The hats violate federal flammability requirements and pose a risk of burn injuries.

    Product
    Halloween Witch Hats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24298·2024-07-11

    Atomi Smart Heaters recalled for fire and burn hazards

    Atomi Smart Heaters can turn on without user input, creating fire and burn risks. About 99,400 units sold nationwide are affected; consumers should stop use immediately and follow refund instructions.

    Product
    Atomi Smart Heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24303·2024-07-11

    TonGass Pool Drain Covers Recalled for Entrapment Hazard

    TonGass 8-inch round pool drain covers do not meet Virginia Graeme Baker Pool and Spa Safety Act standards and pose an entrapment hazard to swimmers and bathers. About 1,650 units sold on Amazon from September 2023 through June 2024 are affected.

    Product
    TonGass pool drain covers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24301·2024-07-11

    Children's Pajama Sets Recalled for Burn Hazard and Flammability Violation

    JUVENNO KIDS is recalling about 18,620 children's button-up pajama sets sold on Temu.com because they violate federal flammability standards for sleepwear and pose a burn injury risk to children. No injuries have been reported.

    Product
    Children's Button-up Short-Sleeve/Shorts Two-Piece Pajama Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24296·2024-07-11

    Children's Pajama Sets Recalled for Flammability Hazard

    About 45,300 children's two-piece pajama sets sold on Temu.com violate federal flammability standards for sleepwear, posing a burn risk to children. Consumers should immediately stop using the garments and contact Fashion Online for a refund.

    Product
    Children's Long-Sleeve/Pants Two-Piece Pajama Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24300·2024-07-11

    Children's Lace Nightgowns Recalled for Burn Hazard

    Lovely Angel children's lace nightgowns sold on Temu.com violate federal flammability standards for sleepwear, posing a burn injury risk to children. About 4,360 units were sold between June 2023 and May 2024.

    Product
    Lovely Angel Children's Lace Nightgowns
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V528000·2024-07-11

    Hyundai and Genesis fuel pump defect may cause loss of power

    Hyundai and Genesis are recalling 2019-2023 vehicles because the fuel pump may fail, causing loss of drive power and increasing crash risk. Dealers will update engine software and inspect/replace the fuel pump as needed.

    Product
    HYUNDAI — HYUNDAI, GENESIS VELOSTER N, G70, ELANTRA N, KONA N
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2259-2024·2024-07-10

    Stryker Flyte Hood Protective Covers Recalled Due to Expired Products

    Stryker Corporation recalled Non-Sterile Flyte hood protective covers that were distributed expired. The affected medical device units may not function as intended.

    Product
    The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood is donned after the Flyte helmet and before the gown, such that the hood is securely tucked inside the gown. The hood attaches to and covers th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2247-2024·2024-07-10

    X-ray cart positioning arm bolt may loosen and fall onto patient

    A bolt securing the positioning arm on First Source iQ Flex M X-ray carts may come loose and fall onto patients. The recall involves 137 units distributed across the US, Korea, and Serbia.

    Product
    First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2265-2024·2024-07-10

    Abbott Liberta RC Pulse Generator Unexpectedly Shuts Down Periodically

    Abbott Liberta RC implantable pulse generators used for deep brain stimulation may unexpectedly turn off approximately every 50 days after activation, resulting in loss of therapy. Approximately 302 units have been recalled nationwide.

    Product
    Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2236-2024·2024-07-10

    Acumatch L-Series Hip Implant Liners Recalled for Packaging Defect

    Exactech is recalling Acumatch L-Series hip implant liners because some units were packaged without the specified protective ethylene vinyl alcohol (EVOH) layer, which is required for proper device protection.

    Product
    Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2255-2024·2024-07-10

    BD Pyxis Medication Cabinets Recalled for Uncertified Power Strip Safety Risk

    BD Pyxis MEDBANK medication cabinets contain power strips not certified to electrical safety standards, potentially exposing users to leakage currents. The recall affects 677 units distributed nationwide.

    Product
    BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK MINI 1HH-1HM-1FM/ 169-102, MEDBANK MINI 1HH-3HM/ 169-103, MEDBANK MINI 2FH/ 169-104, MEDBANK MINI 2FM/ 169-105, MEDBANK MINI 2HH-1FH/ 169-
    Category
    Medical Device
    Distribution
    Distributed nationwide