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.

10851–10875 of 53043

  • HighFDA (Devices)·Z-0414-2024·2023-12-06

    Edwards TruWave pressure monitoring kit recalled for setup issues

    Edwards Lifesciences is recalling 168,014 TruWave with Vamp pressure monitoring kits due to potential flushing difficulties during setup. The recall affects devices distributed across the US and internationally.

    Product
    TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); PXVK0853: x3 (3cc)/VAMP 76in (193cm); PXVK0996:(3cc)/VAMP 68in (174cm); PXVMP2X21: x2 (3cc)/VAMP; PXVMP2X22: x2 (3cc)/VAMP 63 in…
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0406-2024·2023-12-06

    Da Vinci Needle Driver Recalled for Risk of Dislodgement During Surgery

    Intuitive Surgical is recalling 317 units of a Da Vinci Single-Site Wristed Needle Driver due to potential dislodgement or breakage that could result in uncontrollable movement.

    Product
    Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-0475-2024·2023-12-06

    Le Croissant Turkey & Cheddar Sandwich Recalled for Undeclared Milk and Soy

    Le Croissant Turkey & Cheddar sandwiches are being recalled due to undeclared milk and soy allergens. The product was distributed across 15 states.

    Product
    Le Croissant Turkey & Cheddar Net Wt. 5.5oz (156g) UPC:766375261629 Packaged in clamshell container. Sold as single unit and 6-unit pack under Food Unlimited brand
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0474-2024·2023-12-06

    Food Unlimited Ham & Swiss Recalled for Undeclared Milk and Soy

    Food Unlimited-brand Le Croissant Ham & Swiss sandwiches are being recalled due to undeclared milk and soy allergens. Affected products distributed across multiple states should not be consumed by people with these allergies.

    Product
    Le Croissant Ham & Swiss Net Wt. 5.5oz (156g) UPC:766375261612 Packaged in clamshell container. Sold under Food Unlimited brand.
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0470-2024·2023-12-06

    Frito-Lay Chickpea Veggie Crisps recalled for undeclared milk allergen

    Frito-Lay is recalling 16,100 bags of Chickpea Veggie Crisps (UPC 02840020646) due to undeclared milk allergen. Consumers with milk allergies should not consume the product.

    Product
    Chickpea Veggie Crisps, Net Wt. 6 1/4 oz (177.1g), UPC: 02840020646
    Category
    Food
    Distribution
    26 states
  • HighFDA (Devices)·Z-0404-2024·2023-12-06

    Medical Device Recall: SENTIERO Hearing Screening Devices for Technical Distortions

    PATH's SENTIERO SCREENING hearing examination devices (Model SOH100098) are being recalled due to technical distortions that may exceed expected levels. The recall affects devices distributed in Florida, Missouri, Ohio, and Wisconsin.

    Product
    SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-0477-2024·2023-12-06

    Diet Coke 12oz aluminum cans 12-pack recalled for potential foreign material

    Diet Coke 12oz aluminum cans sold in 12-pack fridge packs are being recalled due to potential foreign material. The recall affects 417 cases with specific lot numbers distributed to Alabama, Florida, and Mississippi.

    Product
    Diet Coke packaged in 12oz aluminum cans - 12 pack fridge pack
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0419-2024·2023-12-06

    Olympus EVIS EXERA III Colonoscope Recall for Connector Defect

    24 Olympus EVIS EXERA III colonoscopes distributed to six states are recalled due to improperly repaired connectors that may cause image loss, decreased suction, or improper reprocessing, potentially exposing patients to contaminated equipment.

    Product
    PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0423-2024·2023-12-06

    RAPIDPOINT 500 Blood Gas System: Drug Interference May Cause False Sodium Readings

    Siemens RAPIDPOINT 500 Blood Gas System may produce falsely elevated sodium results due to drug interference from Perhexiline Maleate or Atomoxetine Hydrochloride. This could lead to missed hyponatremia or inappropriate treatment of hypernatremia.

    Product
    RAPIDPOINT 500 Blood Gas System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0422-2024·2023-12-06

    RAPIDPOINT 500e Blood Gas System Recalled Due to Drug Interference

    Siemens RAPIDPOINT 500e blood gas systems may show falsely elevated sodium readings in patients taking Perhexiline Maleate or Atomoxetine, risking misdiagnosis and inappropriate treatment of electrolyte imbalances.

    Product
    RAPIDPOINT 500e Blood Gas System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0471-2024·2023-12-06

    Breakfast sandwich recalled for undeclared milk and soy allergens

    Food Unlimited Breakfast Sandwich Bacon Egg & Cheddar Croissants are recalled due to undeclared milk and soy allergens. The affected products have Use By dates from 10/27/2023 to 11/8/2023.

    Product
    Breakfast Sandwich Bacon Egg & Cheddar Croissant Net Wt. 5.25oz (149g) UPC:766375253051. Packaged in clamshell container. Sold as single unit and 6 unit pack under Food Unlimited brand
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-0411-2024·2023-12-06

    FloTrac Sensor Recalled Due to Potential Flushing Difficulties During Setup

    Edwards Lifesciences is recalling 1417 FloTrac Sensors used for intravascular pressure monitoring due to potential flushing difficulties during kit setup. No illnesses or injuries have been reported.

    Product
    FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0409-2024·2023-12-06

    Acumen IQ Sensor Intravascular Pressure Monitor Flushing Difficulty

    Edwards Lifesciences is recalling 33,327 Acumen IQ Sensors used for intravascular pressure monitoring due to potential flushing difficulties during setup. The devices are distributed across the US and internationally.

    Product
    Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0402-2024·2023-12-06

    Medical Device Screening Tool Recalled Due to Technical Distortion Issues

    PATH is recalling 28 units of SENTIERO Screening2 hearing examination devices due to potential technical distortions. The affected devices were distributed in Florida, Missouri, Ohio, and Wisconsin.

    Product
    SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0418-2024·2023-12-06

    Colonoscope Repair Defect May Cause Device Malfunction and Contamination Risk

    Aizu Olympus colonoscopes with improperly repaired light guide connectors may experience loss of image or suction failure. This could delay treatment and expose patients to contaminated material.

    Product
    PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
    Category
    Medical Device
    Distribution
    6 states
  • HighCPSC·24726·2023-12-05

    Foiresoft Zebra Roller Blinds Recalled for Strangulation Hazard

    Foiresoft Zebra Roller Blinds sold on Amazon.com have looped operating cords that pose a strangulation hazard to children. Consumers should stop using them immediately and contact Softfunch for a refund.

    Product
    Foiresoft Zebra Roller Blinds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V816000·2023-12-05

    Volvo 2024 VN and VHD: Incorrect Axle Weight Label Increases Overload Risk

    Certain 2024 Volvo VN and VHD trucks have an incorrect Gross Axle Weight Rating label, which can allow vehicles to be overloaded and increases crash risk. Dealers will replace the label free of charge.

    Product
    VOLVO — VOLVO VHD, VN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V813000·2023-12-04

    Porsche Recalls 718 Models Due to Spoiler Visibility Issue

    Porsche is recalling certain 2023-2024 718 models because the rear spoiler may raise too high, reducing brake light visibility and increasing crash risk.

    Product
    PORSCHE — PORSCHE 718 BOXSTER S, 718 CAYMAN GTS, 718 BOXSTER GTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V814000·2023-12-04

    2023 INFINITI QX60 Headlight System Malfunction Increases Crash Risk

    Nissan is recalling certain 2023-2024 INFINITI QX60 vehicles because the Adaptive Front-Light System may incorrectly adjust headlights downward at high speeds, reducing visibility and increasing crash risk.

    Product
    INFINITI — INFINITI QX60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V806000·2023-12-01

    Freightliner and Mercedes Sprinter paint defect causes window and rail detachment

    Daimler Vans USA is recalling Freightliner and Mercedes-Benz Sprinter vans from 2021-2023 due to insufficient paint adhesion that may cause windows and interior lashing rails to detach during a crash. No injuries have been reported.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, FREIGHTLINER SPRINTER 1500, SPRINTER 4500, SPRINTER 2500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V805000·2023-12-01

    Prevost motorcoaches recalled for driver assist sensor obstruction and braking failure risk

    Prevost is recalling 2022-2024 H3-45 VIP motorcoaches and 2024 H3-45 models because an incorrect bumper trim panel obstructs the radar sensor, preventing the driver assist system from functioning properly and increasing the risk of crashes.

    Product
    PREVOST — PREVOST H3-45 VIP, H3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24721·2023-11-30

    Vibe Bear Playyard Mattresses Recalled for Suffocation Hazard

    Beyond Baby Vibe Bear-branded playyard mattresses sold on Amazon.com from January to June 2023 are recalled due to suffocation hazards for infants. The mattresses violate federal crib mattress safety standards for firmness, thickness, warnings, and labels.

    Product
    Vibe Bear Playyard Mattresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24720·2023-11-30

    Polaris Model Year 2023 Snowmobiles Recalled for Clutch Failure Injury Hazard

    Polaris is recalling about 2,200 Model Year 2023 PATRIOT 9R MATRYX PRO RMK and PATRIOT 9R MATRYX RMK KHAOS snowmobiles because the primary clutch can fail and cause clutch components to come loose, posing an injury hazard.

    Product
    Model Year 2023 PATRIOT 9R MATRYX PRO RMK and PATRIOT 9R MATRYX RMK KHAOS Snowmobiles
    Category
    Consumer Product
    Distribution
    Distributed nationwide