The Recall Desk

State

Delaware product recalls

73,100 recalls have nationwide distribution and so reach Delaware. 3,438 additional recalls listed Delaware specifically in their distribution scope.

What the numbers show

Total
3,438
Critical
477
Severe
939
Most recent
2026-09-23

Of the 3,438 recalls naming Delaware we have scored against our rubric, 477 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 939 (27%) are Severe.

These figures cover only the 3,438 recalls whose distribution notice names Delaware specifically. The 73,100 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

10851–10875 of 76538

  • 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 (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-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 (Food)·F-1502-2024·2024-07-24

    Canned coffee beverages recalled for potential under-processing

    Snapchill LLC is recalling approximately 549,146 cans of ready-to-drink coffee beverages distributed nationwide and in Canada due to potential under-processing.

    Product
    Coffee + Non-Dairy Creamer + Sugar Canned Beverage packaged under the following brands and sizes: 1. Coffee Hound Coffee Co Nitro with Sugar and Non-Dairy Creamer, 12 oz. UPC 7 83970-58494 6. 2. Euphoria Coffee Sweetened Latte, 12 oz. UPC 8 10149-37096 0. 3. Kahawa 1893 C
    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-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 (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-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-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 (Devices)·Z-2350-2024·2024-07-24

    Autotome RX Cannulating Sphincterotome Recalled for Potential Device Malfunction

    Boston Scientific recalls the Autotome RX Cannulating Sphincterotome due to foreign material on the cutting wire that may prevent proper device function and extend procedure time. No injuries reported.

    Product
    Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2385-2024·2024-07-24

    B. Braun Infusomat 60 IV Pump Sets Recalled for Backcheck Valve Malfunction

    B. Braun is recalling Infusomat 60 infusion pump sets (Model 363010) due to potential backcheck valve malfunction. The defect could cause medication to flow backward into primary IV containers and prevent proper medication delivery.

    Product
    Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2361-2024·2024-07-24

    Abbott Proclaim 7 Implantable Pulse Generator May Reach End-of-Service Sooner Than Labeled

    Abbott is recalling 569 units of the Proclaim 7 implantable pulse generator because the device may reach end-of-service sooner than indicated in labeling. All affected units were distributed worldwide.

    Product
    Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only
    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 (Devices)·Z-2395-2024·2024-07-24

    Infusomat SPACE Pump IV Set Recalled Due to Backcheck Valve Malfunction

    B. Braun Medical is recalling the Infusomat SPACE IV pump set (Model 480255) due to potential backcheck valve malfunction that could allow medication to flow backward between IV containers, potentially causing adverse drug reactions or loss of medication.

    Product
    Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480255
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2359-2024·2024-07-24

    Abbott Proclaim 5 Implantable Pulse Generator Service Life Shorter Than Labeled

    Abbott's Proclaim 5 implantable pulse generator may reach end of service sooner than indicated in product labeling. The time between the elective replacement indicator threshold and complete device failure may be shorter than documented.

    Product
    Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2377-2024·2024-07-24

    IV Infusion Set Backcheck Valve Malfunction May Cause Medication Loss

    B. Braun is recalling OUTLOOK IV Sets due to potential backcheck valve malfunction that could allow medication backflow and loss. The defect may result in adverse drug reactions or medication loss.

    Product
    OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354213
    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-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-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-2373-2024·2024-07-24

    Horizon Bone Densitometer Devices Recalled for Electromagnetic Compatibility Issues

    Hologic Inc. is recalling 2,642 Horizon X-Ray Bone Densitometer units due to non-conformance with electromagnetic compatibility safety standards. The devices exceeded acceptable limits per international technical standard IEC 60601-1-2.

    Product
    Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-WI-CN, Horizon-CI-CN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0612-2024·2024-07-24

    Pravastatin Sodium Tablets Recalled for Failed Dissolution Specifications

    Glenmark Pharmaceuticals is recalling Pravastatin Sodium 80mg tablets nationwide due to failed dissolution specifications. The affected tablets may not dissolve properly, potentially affecting drug absorption.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1499-2024·2024-07-24

    Canned Black Coffee Beverage Recalled for Potential Under-Processing

    Snapchill, LLC is recalling Larry's Coffee Nitro Sweet(ish) canned beverages due to potential under-processing. The recall affects 549,146 cans distributed nationwide and in Canada, with expiration dates between June 16, 2024 and April 16, 2025.

    Product
    Black Coffee + Sweet Syrup Canned Beverage packaged under the following brands and sizes: 1. Larry's Coffee Nitro Sweet(ish), 12 oz. UPC 8 50050-85511 8.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2354-2024·2024-07-24

    Knee Walker Tiller Separation Risk Recalled Due to Fall Hazard

    Medical Depot is recalling Nitro Glide Knee Walker Model 791BL units due to a defect where the tiller may separate from the base assembly. If the device fails, users may fall and sustain injury.

    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: 791BL (Blue)
    Category
    Medical Device
    Distribution
    Distributed nationwide