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.

8076–8100 of 52968

  • HighFDA (Food)·F-1509-2024·2024-07-24

    Snapchill Coffee and Oat Milk Beverage Recall Due to Potential Under-Processing

    Snapchill, LLC is recalling 549,146 cans of Coffee + Oat Milk Canned Beverage distributed nationwide and in Canada due to potential under-processing that may not have eliminated harmful organisms.

    Product
    Coffee + Oat Milk Canned Beverage packaged under the following brands and sizes: 1. Dreamy Coffee Co. Hint of Chocolate, 12 oz. 2. Shirazi Distribution Cafe Au Lait - Little Wolf Corree Roasters, 12 oz. UPC 8 50044-13040 5.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2384-2024·2024-07-24

    IV Pump Sets Recalled for Potential Backcheck Valve Malfunction

    B. Braun Infusomat SPACE IV pump sets may experience backcheck valve malfunction, causing medication backflow between containers and preventing proper IV line priming. This could result in adverse drug reactions, incorrect medication doses, or medication loss.

    Product
    Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362432
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2404-2024·2024-07-24

    IV Infusion Pump Set Recalled for Backflow Risk During Medication Administration

    B. Braun Medical is recalling the OUTLOOK PUMP SET 3 IV infusion sets due to a potential backcheck valve malfunction that could cause medication to backflow from secondary containers into primary containers, risking adverse drug reactions and medication loss.

    Product
    OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V551000·2024-07-23

    Storyteller Overland Recalls 2024 GXV Next for Incorrect Load Label

    Storyteller Overland is recalling 2024 GXV Next vehicles because incorrect cargo capacity labels may allow overloading, increasing crash risk.

    Product
    STORYTELLER OVERLAND — STORYTELLER OVERLAND GXV NEXT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V547000·2024-07-22

    Motiv E-450 BEV Chassis Recalled for Wiring Damage Risk

    Motiv Power Systems is recalling 2021-2024 E-450 BEV chassis vehicles because damaged CAN signal wires could cause a loss of drive power, increasing crash risk.

    Product
    MOTIV — MOTIV E-450 BEV CHASSIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V540000·2024-07-18

    2024 Honda Prologue Front Suspension Control Arm Fracture Recall

    Honda is recalling 2024 Prologue vehicles because the right front lower control arm may contain a manufacturing defect that can fracture, causing loss of vehicle control and increasing crash risk.

    Product
    HONDA — HONDA PROLOGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V541000·2024-07-18

    2021–2025 Winnebago Ekko Motorhomes Solar Charging System Fuse Melt Risk

    Winnebago is recalling 2021–2025 Ekko motorhomes due to inadequate over-current protection in the solar charging system, which can cause the fuse to melt and increase fire risk. Dealers will replace the solar controller fuse and related components at no charge.

    Product
    WINNEBAGO — WINNEBAGO EKKO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24308·2024-07-18

    Manhattan Toy Brilliant Bee Rattles Recalled for Choking Hazard

    Sassy Baby Inc. is recalling about 3,000 Manhattan Toy Brilliant Bee Rattles because the wooden base can detach and release plastic rings that pose a choking hazard to young children.

    Product
    Brilliant Bee Rattles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24309·2024-07-18

    BISSELL Steam Shot Handheld Steam Cleaners Recalled for Burn Hazard

    BISSELL is recalling about 3.2 million Steam Shot Handheld Steam Cleaners because they can expel hot water or steam during heating or use, causing burn injuries. The company has received 183 reports of hot water or steam escaping, including 157 reports of minor burn injuries.

    Product
    BISSELL® Steam Shot™ Handheld Steam Cleaners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0594-2024·2024-07-17

    Compounded Lidocaine-Epinephrine Injectable Recalled Nationwide for Subpotent Epinephrine

    Tailstorm Health Inc is recalling a compounded lidocaine-epinephrine injection nationwide due to subpotent epinephrine component. The recall affects 12,525 vials of lot number 2311003.

    Product
    Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81483 00380 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2338-2024·2024-07-17

    Endoscopic Vessel Harvesting System Recalled for C-Ring Wire Straightening

    Maquet Cardiovascular recalled 2,463 VASOVIEW HEMOPRO 2 surgical systems due to C-Ring wire straightening and component misalignment affecting tool positioning. No injuries have been reported.

    Product
    The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2277-2024·2024-07-17

    Procedure Tray Recalled for Excess Ethylene Oxide Residue

    American Contract Systems is recalling a lower extremity procedure tray (48 units) due to ethylene oxide residuals that exceed FDA safety limits for permanent exposure medical devices.

    Product
    LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2331-2024·2024-07-17

    AURORA Surgiscope System Recalled for Potential Sheath Damage

    Integra LifeSciences is recalling 14 units of the AURORA Surgiscope System due to potential sheath damage that could cause tissue damage or internal bleeding.

    Product
    AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2305-2024·2024-07-17

    Hip Procedure Kit Recalled for Excessive Ethylene Oxide Sterilization Residuals

    American Contract Systems Inc is recalling 393 units of the TPK Anterior Hip Pack nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for permanent exposure medical devices.

    Product
    TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2279-2024·2024-07-17

    TOTAL KNEE Procedure Tray Recalled for Ethylene Oxide Sterilization Residuals

    American Contract Systems is recalling TOTAL KNEE procedure trays (Catalog BFTK01Z, lot 983241) due to ethylene oxide and ethylene chlorohydrin residuals exceeding regulatory limits for permanent-use medical devices.

    Product
    TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2290-2024·2024-07-17

    Total knee prosthesis recalled for excess ethylene oxide residuals

    American Contract Systems Inc is recalling 272 units of its TOTAL KNEE prosthesis nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed safe limits for permanent implants.

    Product
    TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP
    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-2347-2024·2024-07-17

    Blood Pump Rotor Spare Parts Recalled for Loose Guide Sheaves

    Fresenius Medical Care recalls 6 blood pump rotor spare parts used in dialysis machines due to loose or dislodged guide sheaves that developed after clinical use.

    Product
    RTLR190395: 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-2298-2024·2024-07-17

    Knee Arthroscopy Kit Recalled for Excessive Sterilant Chemical Residue

    American Contract Systems Inc is recalling 270 units of a knee arthroscopy surgical kit because sterilization chemical residues exceed safe limits for permanent device contact.

    Product
    KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2283-2024·2024-07-17

    Orthopedic knee procedure tray recalled for sterilization residue levels

    American Contract Systems Inc is recalling 84 units of the ARTHRO KNEE BEACHES PACK BHS procedure tray because residual sterilization chemicals exceeded permissible exposure limits. The affected units were distributed nationwide.

    Product
    ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2345-2024·2024-07-17

    Hemodialysis Blood Pump Rotor Spare Part Recalled for Loose Sheaves

    Fresenius Medical Care is recalling hemodialysis blood pump rotor spare parts due to reports of loose or dislodged guide sheaves. The affected model is distributed nationwide in the U.S. and Canada.

    Product
    RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2323-2024·2024-07-17

    Welch Allyn CP150 Electrocardiograph recalled for missing electromagnetic interference absorber

    Baxter Healthcare is recalling the Welch Allyn CP150 Electrocardiograph because a critical manufacturing step—installation of an electromagnetic interference absorber—was omitted. This could cause device malfunction or interference with nearby medical equipment.

    Product
    Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.
    Category
    Medical Device
    Distribution
    1 state
  • 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-2307-2024·2024-07-17

    CUSTOM KNEE Medical Device Procedure Kit recalled for excess chemical residuals

    American Contract Systems Inc is recalling 174 units of the CUSTOM KNEE - 206061-Procedure Kit due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component. The residuals exceed the safety limits specified in ANSI/AAMI/ISO 10993-7:(R)2012 for permanent-contact medical devices.

    Product
    CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2306-2024·2024-07-17

    Surgical Procedure Kit Recalled for Ethylene Oxide Residual Contamination

    American Contract Systems Inc is recalling the ACL PACK Surgical Procedure Kit due to elevated ethylene oxide and ethylene chlorohydrin residuals that exceed regulatory limits for permanent-contact medical devices.

    Product
    ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA
    Category
    Medical Device
    Distribution
    Distributed nationwide