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.

10776–10800 of 22146

  • HighFDA (Devices)·Z-2355-2024·2024-07-24

    Knee walker recalled for tiller separation that may cause falls

    Medical Depot is recalling the Nitro Glide Knee Walker (model 791RD) because the tiller can separate from the base assembly, potentially causing users to fall. The recall affects 667 units distributed nationwide and in Canada.

    Product
    Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791RD (Red)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2405-2024·2024-07-24

    Zimmer Tourniquet Cuff Recalled Due to Incorrect Port Configuration Labeling

    Stryker is recalling 90 units of Zimmer Tourniquet Cuff 30" because packaging labels them as dual port single bladder, but they actually contain a single port single bladder configuration.

    Product
    REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2362-2024·2024-07-24

    Abbott Proclaim 5 Pulse Generator May Have Shorter Than Labeled Battery Duration

    Abbott Proclaim 5 Implantable Pulse Generators may have a shorter battery lifespan than labeled, potentially affecting replacement timing for patients.

    Product
    Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2389-2024·2024-07-24

    Infusion Pump Component Valve Malfunction May Cause Medication Backflow

    B. Braun's Infusomat infusion pump component can malfunction, causing medication to flow backward from secondary IV lines into primary lines, potentially resulting in improper medication delivery and patient harm.

    Product
    Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1487-2024·2024-07-24

    Lundberg Family Farms Rice Recalled Due to Possible Rodent-Origin Foreign Object

    Wehah Farms is recalling Lundberg Family Farms Sustainable Wild Blend Gourmet Rice because the product may contain a foreign object of apparent rodent origin. Consumers should not consume the recalled product.

    Product
    Lundberg Family Farms Sustainable Wild Blend Gourmet Rice, 1 lb poly bag
    Category
    Food
    Distribution
    7 states
  • HighFDA (Drugs)·D-0597-2024·2024-07-24

    FDA Recalls Nitrofurantoin Capsules Due to Failed Dissolution Specifications

    Sun Pharmaceutical recalls Nitrofurantoin Capsules (100 mg) due to failed dissolution, affecting medication effectiveness. The recall involves 5,752 bottles nationwide in lots 231067 and 231069.

    Product
    NITROFURANTION — NITROFURANTION (NITROFURANTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2378-2024·2024-07-24

    IV Pump Infusion Set Backcheck Valve May Malfunction and Cause Medication Backflow

    B. Braun is recalling the Infusomat UNIV.15DROP PUMP SET (Model 362032) because the backcheck valve may malfunction, allowing medication to flow backward from secondary to primary IV containers, risking medication loss and adverse drug reactions.

    Product
    Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362032
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1513-2024·2024-07-24

    Snapchill Quivr Canned Tea Recalled for Potential Under-Processing

    Snapchill, LLC is recalling 549,146 cans of Quivr brand canned tea beverages nationwide due to potential under-processing, which may allow pathogenic contamination.

    Product
    Tea Canned Beverage packaged under the following brands and sizes: 1. Quivr Hibiscus Tea, 12 oz. UPC 8 50032-47603 4. 2. Quivr Jasmine Green Tea, 12 oz. UPC 8 50032-47603 4. 3. Quivr Golden Black Tea, 12 oz. UPC 8 60000-38051 5. 4. Quivr Jade Oolong Tea, 12 oz. UPC
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2364-2024·2024-07-24

    Abbott Proclaim Plus 5 Pulse Generator Battery Life Shorter Than Labeled

    Abbott is recalling 8,401 units of the Proclaim Plus 5 Implantable Pulse Generator because the battery may reach end-of-service sooner than the product labeling indicates.

    Product
    Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2412-2024·2024-07-24

    Surgical Image Guidance Software May Cause Incorrect Toric IOL Axis Placement

    Surgical image guidance software in NGENUITY 3D systems may miscalculate lens axis placement during eye rotation, potentially causing astigmatic error and decreased visual acuity.

    Product
    Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2400-2024·2024-07-24

    Infusomat SPACE IV Pump Set Recalled for Backcheck Valve Malfunction

    B. Braun is recalling Infusomat SPACE IV pump sets due to a backcheck valve malfunction that could cause medication to flow backward into the primary IV container and prevent proper priming of the line.

    Product
    Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2399-2024·2024-07-24

    IV Infusion Pump Sets Recalled for Backcheck Valve Malfunction

    B. Braun is recalling Infusomat IV infusion pump sets due to potential backcheck valve malfunction that can cause medication to flow backward between IV containers and prevent proper medication delivery.

    Product
    Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number 490102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1482-2024·2024-07-24

    Primal Kitchen Avocado Oil Recalled for Glass Bottle Breakage Risk

    Kraft Heinz Foods Company is recalling Primal Kitchen Avocado Oil in 750ml glass bottles due to potential glass breakage. Affected bottles have Best When Used By dates of August 19-21, 2025.

    Product
    Primal Kitchen Avocado Oil 1PT 9.3 FL OZ (750ml) glass bottle UPC 855232007194, 6 bottles per wholesale case
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-1501-2024·2024-07-24

    Canned black coffee and maple syrup beverage recalled for potential under-processing

    Snapchill, LLC is recalling Mud LLC Maple Mud canned black coffee with maple syrup beverages (12 oz, UPC 854555007058) nationwide and in Canada due to potential under-processing. Affected products have expiration dates from June 16, 2024 to April 16, 2025.

    Product
    Black Coffee + Maple Syrup Canned Beverage packaged under the following brands and sizes: 1. Mud LLC Maple Mud, 12 oz. UPC 8 54555-00705 8.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1507-2024·2024-07-24

    Canned Coffee Beverage Recalled Due to Potential Under-Processing

    Snapchill, LLC is recalling approximately 549,146 cans of Perkatory Coffee Roasters Three Witches Blend due to potential under-processing. Affected cans have expiration dates between June 16, 2024 and April 16, 2025.

    Product
    Coffee + Non-Dairy Creamer + Sugar + Pumpkin Spice Syrup Canned Beverage packaged under the following brands and sizes: 1. Perkatory Coffee Roasters Three Witches Blend, 12 oz. UPC 8 50044-13023 8.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0598-2024·2024-07-24

    Oatmeal Daily Moisturizing Body Lotion Recalled Due to Mold Contamination

    Brands International Corporation is recalling Oatmeal Daily Moisturizing Body Lotion (8 fl oz) due to confirmed mold contamination. The recall affects 120,319 bottles distributed nationwide.

    Product
    Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in an HDPE bottle 12 bottles per case, Manufactured By:/Fabrique Par: , Brands International Corp., Newmarket, ON, L3X 2S2, Made in Canada.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1488-2024·2024-07-24

    Starter Bakery Multigrain Sourdough Bread Recalled for Undeclared Sesame Allergen

    Starter Bakery is recalling Multigrain Sourdough Bread (UPC 8 50025 60902 9) distributed in California because sesame seeds are listed in ingredients but not declared in the allergen warning. People with sesame allergies may unknowingly purchase this product.

    Product
    Starter Bakery Multigrain Sourdough Bread with UPC 8 50025 60902 9
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2370-2024·2024-07-24

    UNITRAX Hip Implant Head Component Recalled for Package Label Size Mismatch

    Howmedica Osteonics is recalling UNITRAX hip implant head components because the package label size may not match the device actually inside, potentially leading to incorrect surgical implantation. Affected units were distributed worldwide.

    Product
    UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1500-2024·2024-07-24

    Snapchill Canned Coffee Beverages Recalled Due to Potential Under-Processing

    Snapchill, LLC recalls Mad Priest Coffee Fallen Angel with Vanilla canned beverages due to potential under-processing. Approximately 549,146 cans with expiration dates between June 16, 2024 and April 16, 2025 are affected.

    Product
    Black Coffee + Vanilla Syrup Canned Beverage packaged under the following brands and sizes: 1. Mad Priest Coffee Fallen Angel with Vanilla, 12 oz. UPC 8 59488-00754 0.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0602-2024·2024-07-24

    Cardura XL Tablets Recalled for Failed Impurities and Degradation Specifications

    Viatris Inc is recalling Cardura XL (doxazosin) 4mg tablets due to failed impurities and degradation specifications. The recall affects 12,691 bottles distributed nationwide.

    Product
    Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10
    Category
    Drug
    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
  • 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
  • HighFDA (Devices)·Z-2326-2024·2024-07-17

    Decompression Table Model E9011 Recalled for Structural Frame Defect

    Pivotal Health Solutions is recalling 32 Decompression Table Model E9011 devices due to potentially insufficient rework on a lumbar frame part. The defect affects units distributed to CA, FL, TX, ID, GA, and TN.

    Product
    Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.
    Category
    Medical Device
    Distribution
    6 states
  • 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