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.

18751–18775 of 50407

  • HighFDA (Devices)·Z-0191-2022·2021-11-10

    Lisendo 880 Ultrasound Software displays incorrect cardiac valve measurements

    Lisendo 880 Ultrasound Software versions V1.0–V4.1.3 may not display cardiac measurement results correctly for mitral valve assessments, affecting diagnostic accuracy.

    Product
    Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2022·2021-11-10

    Siemens COVID-19 Diagnostic Assay Recalled for Inadequate Validation Data

    Siemens is recalling Atellica IM SARS-CoV-2 Antigen Assay kits because validation data submitted to the FDA was insufficient to confirm the assay's accuracy for its intended use.

    Product
    Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0096-2022·2021-11-10

    Picket Fence Creamery Chocolate Cherry Ice Cream Recall for Undeclared Soy

    Picket Fence Creamery is recalling Chocolate Cherry ice cream sold in Iowa due to undeclared soy lecithin, which poses a risk to consumers with soy allergies.

    Product
    Picket Fence Creamery, Woodward, IA, Chocolate Cherry ice cream, in Quarts, Pints, and 1/2 Pints
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0103-2022·2021-11-10

    Picket Fence Creamery Luscious Lemon Ice Cream Recall for Undeclared Soy

    Picket Fence Creamery is recalling Luscious Lemon ice cream in quarts, pints, and half-pints due to the presence of undeclared soy lecithin. Consumers with soy allergies should not consume the product.

    Product
    Picket Fence Creamery, Woodward, IA, Luscious Lemon ice cream, in Quarts, Pints, and 1/2 Pints
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0077-2022·2021-11-10

    Meijer Turkey & Provolone Pretzel Roll Sliders Recalled for Undeclared Soy

    Meijer Inc is recalling Fresh From Meijer Turkey & Provolone Pretzel Roll Sliders due to undeclared soy lecithin. The product may pose a risk to consumers with soy allergies.

    Product
    Fresh From Meijer, Turkey & Provolone Pretzel Roll Sliders, 6.4 Oz., Plastic clam-shell - clear lid, black bottom, UPC 7-13733-76500-8
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0084-2022·2021-11-10

    Hotdog Buns Recalled for Potential Listeria and Salmonella

    Kansas City LLC, operating as Best Harvest Bakeries, is recalling hotdog buns distributed to restaurants across 14 states due to positive environmental samples tested for Listeria and Salmonella species.

    Product
    Hotdog buns, in unlabeled clear plastic bags, 30 or 12 buns per bag.
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-0186-2022·2021-11-10

    Flexor Check-Flo Introducer Sets recalled due to misplaced radiopaque marker band

    Cook Inc. recalls Flexor Check-Flo Introducer Sets where the radiopaque marker band is incorrectly positioned, which may not be discovered until the device is used in a patient under fluoroscopy, increasing procedural time.

    Product
    Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Food)·F-0105-2022·2021-11-10

    Picket Fence Creamery S'mores Ice Cream Recalled for Undeclared Soy

    Picket Fence Creamery is recalling S'mores ice cream in multiple sizes due to undeclared soy lecithin, which poses a risk to consumers with soy allergies.

    Product
    Picket Fence Creamery, Woodward, IA, S'mores! ice cream, in Quarts, Pints, and 1/2 Pints
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·21V874000·2021-11-10

    Audi Recalls A4, A5, S4, S5, RS 5 Models Due to Air Bag Defect

    Audi is recalling specific 2017-2020 models because a cable fault may disable the passenger air bag, increasing injury risk in a crash.

    Product
    AUDI — AUDI A4, A5, RS 5, S5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0078-2022·2021-11-10

    Hamburger Buns Recalled for Potential Listeria and Salmonella Contamination

    Kansas City LLC, doing business as Best Harvest Bakeries, is recalling hamburger buns distributed to restaurants across 14 states due to positive environmental samples for Listeria and Salmonella species.

    Product
    Hamburger buns, customer specified formula, in unlabeled clear plastic bags, 30 or 12 buns per bag.
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0101-2022·2021-11-10

    Picket Fence Creamery Dutch Letter Ice Cream Recalled for Undeclared Almonds

    Picket Fence Creamery is recalling Dutch Letter ice cream due to undeclared almonds. The product label declares nuts but does not specify almonds, posing a risk to consumers with almond allergies.

    Product
    Picket Fence Creamery, Woodward, IA, Dutch Letter! ice cream, in Quarts, Pints, and 1/2 Pints
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0106-2022·2021-11-10

    Picket Fence Creamery White Chocolate Raspberry Ice Cream Recall for Undeclared Soy

    Picket Fence Creamery is recalling White Chocolate Raspberry ice cream because it contains undeclared soy lecithin, which poses a risk to consumers with soy allergies.

    Product
    Picket Fence Creamery, Woodward, IA, White Chocolate Raspberry ice cream, in Quarts, Pints, and 1/2 Pints
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0083-2022·2021-11-10

    Potato buns recalled due to Listeria and Salmonella detection

    Kansas City LLC., operating as Best Harvest Bakeries, is recalling potato buns distributed to restaurants across 14 states due to positive environmental samples detected for Listeria and Salmonella species.

    Product
    Potato buns, in unlabeled clear plastic bags, 30 or 12 buns per bag.
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-0187-2022·2021-11-10

    COVENA PICC Sleeve Recalled for Unauthorized FDA Marketing

    Queen Comfort Products is recalling the COVENA PICC Sleeve, marketed without FDA clearance. Patients currently using the device should contact their healthcare provider immediately.

    Product
    COVENA PICC Sleeve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0200-2022·2021-11-10

    Artis zeego X-Ray System Software Error Affects Image Reconstruction

    Siemens Artis zeego fluoroscopic X-ray systems have a software error that incorrectly displays 3D image reconstruction when the patient table is rotated more than 4 degrees, potentially resulting in incorrect patient treatment during image-guided procedures.

    Product
    Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0082-2022·2021-11-10

    Hamburger buns recalled due to Listeria and Salmonella contamination risk

    Kansas City LLC., operating as Best Harvest Bakeries, is recalling hamburger buns distributed to restaurants across 15 states due to positive environmental samples for Listeria and Salmonella species.

    Product
    Hamburger buns, 5" in unlabeled clear plastic bags, 30 or 12 buns per bag.
    Category
    Food
    Distribution
    15 states
  • HighNHTSA·21V870000·2021-11-10

    Ford recalls 2021 Explorer and Lincoln Aviator suspension modules

    Ford is recalling certain 2021 Explorer and Lincoln Aviator vehicles with incorrect rear suspension module components due to a labeling error. The defect may affect vehicle handling, ride height, and braking, increasing crash risk.

    Product
    FORD — FORD, LINCOLN EXPLORER, AVIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0119-2022·2021-11-10

    Mountain View Bakery Peaches and Crème Cake Recall Due to Undeclared Milk

    Mountain View Bakery is recalling Peaches and Crème Cake (4oz and 8oz) sold at Pilot gas stations in Tennessee because the product contains undeclared milk, a common allergen that poses a serious health risk to consumers with milk allergies.

    Product
    Mountain View Bakery Peaches and Cr¿me Cake 4oz or 8oz packaged in plastic clamshell sold individually
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0079-2022·2021-11-10

    Hotdog Buns Recall Due to Potential Listeria and Salmonella Contamination

    Kansas City LLC., DBA Best Harvest Bakeries is recalling hotdog buns distributed to restaurants across 15 US states due to positive environmental samples for Listeria and Salmonella species.

    Product
    Hotdog buns, customer specified formula, in unlabeled clear plastic bags, 30 or 12 buns per bag.
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0102-2022·2021-11-10

    Picket Fence Creamery Key Lime Pie Ice Cream Recall

    Picket Fence Creamery is recalling Key Lime Pie ice cream due to undeclared wheat and soy lecithin, and lack of gluten-free labeling. The product was distributed to grocery stores in Iowa.

    Product
    Picket Fence Creamery, Woodward, IA, Key Lime Pie! ice cream, in quarts, pints and 1/2 pints
    Category
    Food
    Distribution
    1 state
  • HighCPSC·22017·2021-11-10

    Hart 18-Gauge 2" Brad Nailers Recalled for Involuntary Nail Discharge

    Hart Consumer Products is recalling about 15,700 Hart 18-Gauge 2" Brad Nailers because the contact sensor can malfunction and cause the tool to involuntarily discharge a nail, posing a risk of serious injury.

    Product
    Hart 18-Gauge 2" Brad Nailers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0190-2022·2021-11-10

    Arietta 850 Ultrasound Software Displays Cardiology Measurements Incorrectly

    FujiFilm Arietta 850 ultrasound systems with affected software versions display cardiology measurement results incorrectly. The recall affects 38 units distributed nationwide.

    Product
    Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0081-2022·2021-11-10

    Hamburger buns recalled for potential Listeria and Salmonella contamination

    Kansas City LLC., doing business as Best Harvest Bakeries, is recalling hamburger buns distributed to restaurants across multiple states due to positive environmental samples for Listeria and Salmonella species.

    Product
    Hamburger buns, 4.5" in unlabeled clear plastic bags, 30 or 12 buns per bag.
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0133-2022·2021-11-10

    Chocolate Chip Cookie Dough Recalled for Undeclared Tree Nut Allergen

    Craftmark Bakery is recalling Chocolate Chip Cookie Dough (Tiff's Treats brand) due to undeclared tree nut allergen. The product was distributed to 68 retailers through 3 distributors.

    Product
    Chocolate Chip Cookie Dough packaged in 1 case, 6 bags/case, and 30 frozen pies of dough/bag. Labeling reads "Chocolate Chip Cookie Dough***Tiff's Treats***Do not consume raw***"
    Category
    Food
    Distribution
    0 states