The Recall Desk

State

Hawaii product recalls

20,199 recalls have nationwide distribution and so reach Hawaii. 0 additional recalls listed Hawaii specifically in their distribution scope.

About recalls in Hawaii

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Hawaii consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

8351–8375 of 20199

  • 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-2392-2024·2024-07-24

    Infusomat UNIV. 15 IV Pump Set Recalls Due to Backcheck Valve Malfunction

    B. Braun is recalling Infusomat UNIV. 15 IV pump sets because the backcheck valve may malfunction, potentially causing medication backflow or loss, which could lead to adverse drug reactions.

    Product
    Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363430
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2375-2024·2024-07-24

    Blood collection tubes recalled for missing additive and separation failures

    Greiner Bio-One is recalling VACUETTE blood collection tubes due to missing additive affecting clotting and separation. Defective tubes could delay patient treatment if samples require recollection.

    Product
    VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2368-2024·2024-07-24

    Abbott Recalls Proclaim 7 Elite Pulse Generator for Battery Life Discrepancy

    Abbott Medical is recalling Proclaim 7 Elite Implantable Pulse Generators because the device may reach end of service sooner than indicated in the product labeling. Patients should consult their healthcare provider.

    Product
    Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
    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 (Devices)·Z-2410-2024·2024-07-24

    Knee Prosthesis Tibial Component Screws Cannot Be Loosened During Surgery

    The Endo Model M tibial components cannot be loosened during surgery, preventing surgeons from making necessary intraoperative adjustments. This may force unplanned procedure changes.

    Product
    Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0601-2024·2024-07-24

    Fludrocortisone Acetate Tablets recalled nationwide due to failed impurity and degradation specifications

    Teva Pharmaceuticals is recalling Fludrocortisone Acetate Tablets 0.1mg nationwide and in Puerto Rico due to impurities and degradation substances exceeding specification limits.

    Product
    Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0997-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1506-2024·2024-07-24

    Coffee and Cream Canned Beverages Recalled for Potential Under-Processing

    Snapchill, LLC is recalling 549,146 cans of Coffee Hound and White Rhino coffee beverages for potential under-processing. Affected cans with expiration dates June 16, 2024–April 16, 2025 were distributed nationwide and in Canada.

    Product
    Coffee + Non-Dairy Creamer + Caramel Syrup Canned Beverage packaged under the following brands and sizes: 1. Coffee Hound Coffee Co Maine Caramel & Cream, 12 oz. UPC 6 15764-22852 4. 2. White Rhino Coffee Sebastain, 12 oz. UPC 8 10149-37084 7.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1505-2024·2024-07-24

    Canned Coffee Beverages Recalled for Potential Under-Processing Risk

    Snapchill, LLC is recalling approximately 549,146 cans of Coffee Hound and Helm brand maple latte beverages due to potential under-processing during manufacturing.

    Product
    Coffee + Non-Dairy Creamer + Maple Syrup Canned Beverage packaged under the following brands and sizes: 1. Coffee Hound Coffee Co Maple Leaf Latte, 12 oz. UPC 7 83970-58496 0. 2. Helm Coffee Nitro Maple Latte, 12 oz. UPC 8 10149-37065 6.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2397-2024·2024-07-24

    IV Infusion Pump Set Valve May Cause Dangerous Medication Backflow

    B. Braun's Infusomat pump sets may have faulty backcheck valves causing medication to backflow between IV bags, risking reduced medication delivery and adverse reactions. All units distributed worldwide after August 2023 are affected.

    Product
    Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2387-2024·2024-07-24

    B. Braun Infusomat SPACE IV Set Backcheck Valve Malfunction Recall

    B. Braun Medical is recalling 68,205 Infusomat SPACE IV Sets due to a potential backcheck valve malfunction that could allow medication backflow between IV containers.

    Product
    Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363420
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2383-2024·2024-07-24

    B. Braun Infusomat IV Pump Set Recalled Due to Backflow Risk

    B. Braun Medical recalls Infusomat UNIV. 15 DROP PUMP SET units due to a potential backcheck valve malfunction that could cause medication backflow and adverse drug reactions.

    Product
    Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362431
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1511-2024·2024-07-24

    Canned Coffee Beverage Recalled for Potential Manufacturing Under-Processing

    Snapchill, LLC is recalling Fire Grounds Coffee Co. Vanilla Nito canned beverages due to potential under-processing. Approximately 549,146 cans were distributed nationwide in the United States and Canada.

    Product
    Coffee + Oat Milk + Vanilla Syrup Canned Beverage packaged under the following brands and sizes: 1. Fire Grounds Coffee Co. Vanilla Nito, 12 oz. UPC 8 50050-85504 0.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0611-2024·2024-07-24

    Potassium Chloride Extended Release Capsules Recalled for Dissolution Defect

    RemedyRepack Inc. is recalling Potassium Chloride Micro 10mEq K Extended Release Capsules because they fail to meet dissolution specifications, which could affect medication effectiveness.

    Product
    Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1203-03
    Category
    Drug
    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 (Devices)·Z-2352-2024·2024-07-24

    Medtronic Ascenda Intrathecal Catheter design update to prevent occlusion

    Medtronic is updating the design of its Ascenda Intrathecal Catheter (Models 8780, 8781, 8784) to reduce potential tissue growth into the catheter connector that may cause occlusion. Approximately 111,762 units were distributed worldwide.

    Product
    Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2406-2024·2024-07-24

    Surgical Hemostatic Device Recalled for Compromised Sterile Barrier

    Ethicon is recalling SURGICEL FIBRILLAR hemostatic pads due to torn foil pouches that compromise the sterile barrier, traced to a specific packaging machine defect.

    Product
    SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1497-2024·2024-07-24

    FDA Recalls Black Coffee Beverages Due to Potential Under-Processing

    Snapchill, LLC is recalling approximately 549,146 cans of Black Coffee + Chocolate Syrup canned beverages marketed under Bold Bean Coffee Roasters and Larry's Coffee brands due to potential under-processing that may allow pathogenic growth.

    Product
    Black Coffee + Chocolate Syrup Canned Beverage packaged under the following brands and sizes: 1. Bold Bean Coffee Roasters The Chocolate One, 12 oz. UPC 8 10149-37108 0. 2. Larry's Coffee Nitro Mocha, 12 oz. UPC 8 50050-85512 5.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2394-2024·2024-07-24

    Infusomat SPACE Pump IV Sets Recalled for Backcheck Valve Malfunction

    B. Braun's Infusomat SPACE Pump IV sets are recalled due to a potential backcheck valve malfunction that could cause medication backflow and inability to prime. The defect affects approximately 109,464 units distributed in the US and Canada.

    Product
    Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480254
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2404-2024·2024-07-24

    IV Infusion Pump Set Recalled for Backflow Risk During Medication Administration

    B. Braun Medical is recalling the OUTLOOK PUMP SET 3 IV infusion sets due to a potential backcheck valve malfunction that could cause medication to backflow from secondary containers into primary containers, risking adverse drug reactions and medication loss.

    Product
    OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1495-2024·2024-07-24

    Black coffee canned beverages recalled nationwide for potential under-processing

    Snapchill, LLC is recalling 549,146 cans of black coffee beverages nationwide and in Canada due to potential under-processing. Affected cans have expiration dates between June 16, 2024 and April 16, 2025.

    Product
    Black Coffee Canned Beverage packaged under the following brands and sizes: 1. 41 & Change Coffee Co A Finca / Nicaragua Cold Coffee, 12 oz. UPC 1 97644-95863 4. 2. Alchemy Roast Elixir or Life (Gutemala/Huehuetenango Blend) 12 oz. UPC 8 10149-37056 4. 3. Amavida Coffe Roa
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2374-2024·2024-07-24

    BD Pyxis Automated Dispensing Cabinets Software Error Prevents Medication Access

    BD Pyxis automated dispensing cabinets with ES 1.7.x software may display errors preventing medication access when Component Manager is in 'installed mode' and patch KB 5033688 is applied.

    Product
    BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1496-2024·2024-07-24

    Canned Coffee Beverages Recalled for Potential Under-Processing

    Snapchill, LLC is recalling 549,146 cans of Black Coffee + Sugar beverages under the brands Bold Bean Coffee Roasters and Kahawa 1893 Coffee Inc. due to potential under-processing during manufacturing.

    Product
    Black Coffee + Sugar Canned Beverage packaged under the following brands and sizes: 1. Bold Bean Coffee Roasters The Sweet One, 12 oz. UPC 8 10149-37110 3. 2. Kahawa 1893 Coffee Inc. Sweet Kenyan, 12 oz. UPC 8 50033-95733 4.
    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