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.

10701–10725 of 22146

  • HighFDA (Devices)·Z-2388-2024·2024-07-24

    Infusion pump IV administration set recalled for backcheck valve malfunction risk

    B. Braun is recalling Infusomat UNIV. 15 DROP PUMP SET infusion sets due to potential backcheck valve malfunction that may cause medication to flow backward into primary IV containers and prevent proper priming, risking adverse drug reactions.

    Product
    Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363421
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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-2353-2024·2024-07-24

    Qiagen QIAcube Connect MDx heating failure may cause erroneous diagnostic results

    A heating defect in the Qiagen QIAcube Connect MDx may prevent proper incubation temperatures below 40°C, potentially affecting diagnostic test results.

    Product
    QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900370 Software Version: 1.0.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1514-2024·2024-07-24

    Canned tea beverage recalled due to potential under-processing

    Snapchill, LLC is recalling Square One Coffee Roasters Berry Mint Tea with Honey canned beverages due to potential under-processing. The affected cans were distributed nationwide and in Canada.

    Product
    Tea + Honey Canned Beverage packaged under the following brands and sizes: 1. Square One Coffee Roasters Berry Mint Tea with Honey, 12 oz. UPC 8 54555-00743 0.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2348-2024·2024-07-24

    Agilis NxT Steerable Introducer Recalled for Dilators Too Short

    St. Jude Medical is recalling 129 units of the Agilis NxT Steerable Introducer due to dilators that are too short and will not extend outside the introducer sheath. The defect may prevent proper device function.

    Product
    St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2360-2024·2024-07-24

    Abbott Proclaim XR 7 Implantable Pulse Generator Service Life Shorter Than Labeled

    Abbott Proclaim XR 7 implantable pulse generators may have a shorter service life than indicated in product labeling. Approximately 9,006 units distributed worldwide are affected.

    Product
    Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
    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-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 (Devices)·Z-2357-2024·2024-07-24

    Surgical Awl Recalled Due to Insufficient Weld Integrity

    SeaSpine Orthopedics is recalling the Meridian Angled Awl Fixed surgical instrument due to insufficient weld around the cap component that may fail under impaction forces during surgery.

    Product
    Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2408-2024·2024-07-24

    High Flow Insufflation Tubing Recalled for Incomplete Seals

    Canadian Hospital Specialties is recalling HIGH FLOW INSUFFLATION TUBING with incomplete seals that may result in non-sterile product. The defect affects 6,300 units and poses patient safety concerns.

    Product
    Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1504-2024·2024-07-24

    Canned Coffee Beverages Recalled for Potential Under-Processing Risk

    Snapchill is recalling 549,146 cans of Heine Brothers Coffee Toasted Coconut for potential under-processing. Products were distributed nationwide and in Canada with expiration dates from June 2024 through April 2025.

    Product
    Coffee + Non-Dairy Creamer + Sugar + Coconut Syrup Canned Beverage packaged under the following brands and sizes: 1. Heine Brothers Coffee Toasted Coconut, 8 oz. UPC 8 10149-37052 6. 2. Heine Brothers Coffee Toasted Coconut, 7.5 oz. UPC 8 10149-37093 9.
    Category
    Food
    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 (Devices)·Z-2403-2024·2024-07-24

    IV Infusion Pump Set Recalled for Backcheck Valve Malfunction Risk

    B. Braun is recalling the Infusomat UNIV. 15 DROP PUMP SET due to potential backcheck valve malfunction that could cause medication backflow and loss. The defect may result in adverse drug reactions or improper medication delivery.

    Product
    Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 363230
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2411-2024·2024-07-24

    Endo Model SL Tibial Components Recalled for Inoperable Blind Screws

    Waldemar Link is recalling Endo Model SL Tibial Components used in knee replacement surgery because the blind screws on the modular components cannot be loosened during surgery, potentially prolonging procedures and forcing surgeons to change their planned approach.

    Product
    Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2379-2024·2024-07-24

    Infusion Pump Sets Recalled for Potential Backflow of Medication

    B. Braun is recalling Infusomat UNIV. 15 IV pump sets due to a backcheck valve malfunction that could divert medication between containers and prevent proper priming.

    Product
    Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 362033
    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-1484-2024·2024-07-24

    Wegmans Frozen Cut Green Beans recalled due to potential rodent contamination

    Nortera Foods USA is recalling Wegmans brand Frozen Cut Green Beans (16oz bags) distributed in New York and Pennsylvania because they may contain a foreign object of rodent origin. Approximately 5,200 cases are affected.

    Product
    Wegmans brand Frozen Cut Green Beans; 16oz bags
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2401-2024·2024-07-24

    Infusomat UNIV 60 IV Infusion Pump Set Recalled for Valve Malfunction Risk

    B. Braun is recalling Infusomat UNIV 60 IV infusion pump sets due to a backcheck valve defect that could cause medication backflow between IV containers and prevent priming, potentially resulting in adverse drug reactions or medication loss.

    Product
    Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number : 490104
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2365-2024·2024-07-24

    Abbott Proclaim Plus 5 Pulse Generator May Have Shorter Service Life Than Labeled

    Abbott is recalling 38 Proclaim Plus 5 Implantable Pulse Generators because they may reach end of service sooner than product labeling indicates, potentially affecting pain management therapy for affected patients.

    Product
    Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1512-2024·2024-07-24

    Knowledge Perk Coffee Shandy cans recalled for potential under-processing

    Snapchill, LLC is recalling Knowledge Perk 'The Ace' Coffee Shandy 12 oz cans due to potential under-processing during manufacturing. The recall affects 549,146 cans distributed nationwide in the US and Canada with expiration dates from June 16, 2024 through April 16, 2025.

    Product
    Coffee + Lemonade Concentrate + Vanilla Syrup Canned Beverage packaged under the following brands and sizes: 1. Knowledge Perk "The Ace" Coffee Shandy, 12 oz. UPC 8 10149-37100 4.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2386-2024·2024-07-24

    Infusion Pump Set Recalled for Potential Backcheck Valve Malfunction and Medication Backflow

    B. Braun's Infusomat UNIV. 15 IV infusion pump set is being recalled due to a potential backcheck valve malfunction that could cause medication to backflow from secondary into primary IV containers, potentially resulting in patient injury.

    Product
    Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363030
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2372-2024·2024-07-24

    UNITRAX Hip Endoprosthesis Head Components Mislabeled with Incorrect Package Sizes

    Howmedica Osteonics Corp. is recalling UNITRAX Endoprosthesis Head Components because the package label size may not match the actual device inside. Mislabeling could result in the wrong implant size being used during hip surgery.

    Product
    UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038
    Category
    Medical Device
    Distribution
    Distributed nationwide