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.

24551–24575 of 50442

  • HighFDA (Devices)·Z-0249-2020·2019-11-06

    Intuitive Surgical Recalls EndoWrist Suction Irrigator Due to Silicone Particle Risk

    Intuitive Surgical is recalling EndoWrist Suction Irrigator instruments because silicone particles may form and be introduced into patients during irrigation.

    Product
    EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0233-2020·2019-11-06

    ConvaTec Recalls Convex Two-Piece Ostomy Skin Barriers Due to Off-Center Stoma Hole

    ConvaTec is recalling convex two-piece ostomy skin barriers manufactured between February 2017 and September 2018 because the stoma hole may be off-center.

    Product
    Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3) Natura 4) Varicare Product Usage: stoma management
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·19V795000·2019-11-06

    Blue Bird Recalls 2013-2020 Vision School Buses for Brake Light Defect

    Blue Bird is recalling 2013-2020 Vision school buses with Ford engines because brake lights may stay on continuously, increasing crash risk.

    Product
    BLUE BIRD — BLUE BIRD VISION, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0255-2020·2019-11-06

    Centurion Medical Recalls Port Access Kits Due to Needle Issue

    Centurion Medical Products Corporation is recalling 11,260 Port Access Kits distributed in Illinois. The recall was initiated by the supplier due to an issue with GRIPPER Needles.

    Product
    Kit, Port Access Product Code: DYNDC1582A
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0227-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Soft Guidewires for Sterility Concerns

    Stryker Neurovascular is recalling 831 units of Synchro2 Soft Guidewires due to a potential loss of sterility. The recall covers units distributed worldwide.

    Product
    Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V796000·2019-11-06

    Blue Bird Recalls Vision Transit Buses Due to Brake Light Switch Defect

    Blue Bird is recalling 2013-2020 Vision transit buses with Ford engines because a defective brake light switch bracket may cause brake lights to stay on, increasing crash risk.

    Product
    BLUE BIRD — BLUE BIRD VISION, VISION TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2020·2019-11-06

    Valeritas Recalls DEMO No Needle Corrugated Cartons Due to Needle Risk

    Valeritas is recalling 21,714 DEMO No Needle Corrugated Cartons because they may contain a needle. The recall covers units distributed nationwide in the U.S.

    Product
    DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0234-2020·2019-11-06

    Pajunk Sprotte Lumbar Puncture Needles Recalled for Sterility Concerns

    Pajunk GmbH is recalling Sprotte Lumbar Puncture Needles because a packaging sealing issue may affect sterility. The recall covers 40,475 devices distributed worldwide.

    Product
    SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box); 3. Sprotte 19G x 90mm w/ introducer and wings (25/box]); 4. Sprotte 22G x 103mm w…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0220-2020·2019-11-06

    LivaNova Recalls SORIN Heater-Cooler Systems Due to Disinfectant Failure

    LivaNova USA Inc. is recalling SORIN Heater-Cooler System 3T units because a chemical reaction may render the water preservative ineffective, potentially allowing micro-organism growth.

    Product
    SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling system. The three separate water circuits have been developed to serve as: "…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0252-2020·2019-11-06

    BD Vacutainer Eclipse Blood Collection Needles Recalled for Missing Bevel

    Becton Dickinson is recalling specific lots of BD Vacutainer Eclipse Blood Collection Needles because a missing bevel on the non-patient end caused blood leakage.

    Product
    BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-0075-2020·2019-11-06

    New Seasons Market Recalls Honey Cake Due to Undeclared Milk Allergen

    New Seasons Market LLC is recalling Honey Cake because the packaging lists buttermilk and sour cream but fails to declare milk as an allergen.

    Product
    Honey Cake, internal PLU code 203190, is a seasonal bakery product. A loaf shaped cake is wrapped with cellophane, stored ambient, and sold from displayed tables. The orange sticker on top of the package is read in parts: "***SEASONAL HONEY CAKE ***Made in small batches…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0076-2020·2019-11-06

    Han Yang Honey Donuts Recalled for Undeclared Wheat

    Han Yang Corp. is recalling Honey Donuts (Yahk Gwa) due to undeclared wheat. The product was distributed in Washington state.

    Product
    Honey Donut (Yahk Gwa), brand name Han Yang, packaged in a white Styrofoam boat wrapped in plastic wrap, 8 pieces per package, net wt. 18 oz. UPC 0 72148 48044 0. Product's label is read in parts: "***YAHK GWA*** Ingredients: Sweet Rice, Flour, Corn Syrup, Vegetable Oil…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0251-2020·2019-11-06

    Eversense CGM Sensors Recalled for Premature Function Failure

    Senseonics is recalling 1,344 Eversense CGM sensors nationwide because they may stop working early due to inadequate hydration of the glucose-sensing surface.

    Product
    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19C003000·2019-11-05

    Merritt Recalls Angel Guard Angel Ride Car Beds Due to Harness Defect

    Merritt Manufacturing is recalling Angel Guard Angel Ride car beds because the restraint harness may not be properly sewn, increasing injury risk in a crash.

    Product
    CHILD SEAT:HARNESS:STRAP/WEBBING recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V793000·2019-11-05

    McElrath Trailers Recalls 2014-2019 VX Models for Missing Reflectors

    McElrath Trailers is recalling 2014-2019 VX trailers because side marker LED lights may lack required reflex reflectors, reducing visibility.

    Product
    MCELRATH TRAILERS — MCELRATH TRAILERS VX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V794000·2019-11-05

    KZRV Recalls 2019-2020 Trailers With Detaching Rear Storage Racks

    KZRV is recalling 2019-2020 Connect and Sportsmen trailers because optional Rock Run rear storage racks may detach when loaded, creating a road hazard.

    Product
    KZRV — KZRV CONNECT, SPORTSMEN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V792000·2019-11-04

    Daimler Recalls Western Star Trucks for Detaching Vent Windows

    Daimler Trucks is recalling 2,725 Western Star 4900 and 5700 trucks because sleeper cab vent windows may detach due to improper adhesive.

    Product
    WESTERN STAR — WESTERN STAR 4900, 5700
    Category
    Vehicle
    Distribution
    Distributed nationwide