The Recall Desk

State

Delaware product recalls

73,187 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 73,187 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

13551–13575 of 76625

  • HighFDA (Devices)·Z-0697-2024·2024-01-17

    Olympus ENDOEYE HD II Videoscope Image Discoloration Recall

    Two Olympus ENDOEYE HD II Rigid Videoscope catalog numbers (WA50040A, WA50042A) have been recalled due to reports of pink or green image discoloration during use. The issue could require device exchange during surgery and potentially result in visual impacts or bleeding.

    Product
    Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V018000·2024-01-17

    Heartland Recalls 2024 Corterra Fifth Wheels for Incorrect Tire Labels

    Heartland is recalling 2024 Corterra fifth wheels because certification labels may have missing or incorrect tire size information, potentially leading to the installation of wrong tires.

    Product
    HEARTLAND — HEARTLAND CORTERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0698-2024·2024-01-17

    Medtronic Percutaneous Surgical Pins Recalled Due to Potential Fitting Defects

    Medtronic is recalling 4,235 percutaneous surgical pins that may have a manufacturing defect preventing proper fit into or removal from the tap cap. The pins were distributed nationwide and internationally.

    Product
    Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0677-2024·2024-01-17

    Philips BrightView Gamma Camera System Recalled for Extremity Entrapment Hazard

    Philips is recalling BrightView Gamma Camera Systems because a gap can form between patient support and detector during quality assurance scans, creating an extremity entrapment hazard that may cause fractures or crush injuries.

    Product
    BrightView, Gamma Camera System, Product Code 882480.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0676-2024·2024-01-17

    BD Recanalization System May Overheat or Break During Use

    Bard Peripheral Vascular is recalling BD Recanalization Systems due to a manufacturing defect that may allow continuous operation without required safety warnings, increasing risk of device overheating or breaking during patient treatment.

    Product
    BD Recanalization System, REF: BDRECANSYSTEM
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0640-2024·2024-01-17

    Philips Incisive CT Scanner Software Issues May Cause Misdiagnosis

    Philips is recalling Incisive CT scanners due to nine software defects including image artifacts, incorrect orientation labels, display failures, and positioning errors that could lead to misdiagnosis or need for rescans. No illnesses have been reported.

    Product
    Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0701-2024·2024-01-17

    VADER Pedicle System Torque Wrench Recalled Due to Defective Tightening Function

    Icotec is recalling VADER pedicle system torque wrenches because the torque limiting function can malfunction, potentially leaving screw fasteners insufficiently tightened during implant surgery.

    Product
    VADER pedicle system, torque wrench, Catalog Number 42-703
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0641-2024·2024-01-17

    Medical diagnostic reagent recall: incorrect cell staining fluorescence

    BD Biosciences is recalling CD11b APC diagnostic reagent vials that may produce dim fluorescence signals, potentially causing false negative results and misdiagnosis of blood cancers.

    Product
    CD11b APC: ASR, REF: 340936, and CE, REF: 333143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0644-2024·2024-01-17

    Olympus ENDOEYE Videoscope Recalled for Reprocessing Instructions Deviations

    Olympus Corporation recalls 1,403 ENDOEYE Flex endoscopic videoscopes due to deviations in reprocessing instructions. Affected devices may not be reprocessed properly for safe reuse in surgical procedures.

    Product
    OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0652-2024·2024-01-17

    Abiomed Introducer Kit Sterile Barrier Compromise Due to Pouch Defect

    Abiomed Introducer Kits may have holes in outer pouches that compromise sterility, exposing patients to bacterial contamination and risk of infection, bacteremia, or sepsis.

    Product
    Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3046
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0646-2024·2024-01-17

    Medical Device Recall: Abiomed Axillary Insertion Introducer Sterile Barrier Breach

    Abiomed Axillary Insertion Introducer Kits have holes in the outer pouch that may compromise sterility, potentially exposing patients to serious infections including bacteremia and sepsis.

    Product
    Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 Individual, and Part of Pump Set (005062, 0550-0008, 1000100, 0052-0011, 1000220)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0221-2024·2024-01-17

    FDA Recalls Desloratadine Tablets Due to Manufacturing Defect

    Lupin Pharmaceuticals is recalling Desloratadine 5mg tablets distributed nationwide because N-Nitroso impurity levels exceeded acceptable limits. Affected lots expire in January 2024.

    Product
    DESLORATADINE — DESLORATADINE (DESLORATADINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0682-2024·2024-01-17

    ARCHITECT c4000 Processing Module recalled for unlabeled latex component

    Abbott ARCHITECT c4000 Processing Module laboratory analyzers are recalled due to unlabeled dry natural rubber (latex) subcomponents. Individuals with latex allergies may experience allergic reactions if exposed to the undisclosed component.

    Product
    ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0715-2024·2024-01-17

    MRI systems at risk of unintended magnet shutdown during power loss

    Philips Ingenia Ambition X and S MRI systems may experience uncontrolled shutdown of the sealed magnet if cryo-cooling is lost due to power outages. This could disrupt patient scans and operations.

    Product
    (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-0649-2024·2024-01-17

    Abiomed Introducer Kit recalled due to sterile barrier compromise risk

    Abiomed is recalling Introducer Kits (part 0052-3021) with holes in the outer pouch that compromise the sterile barrier, potentially exposing patients to infection. The kits were distributed nationwide and internationally.

    Product
    Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the body
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0223-2024·2024-01-17

    Tizanidine 4mg Tablets Recalled for Contamination with 2mg Tablets

    Dr. Reddy's Laboratories is recalling Tizanidine 4mg tablets due to the presence of 2mg tablets in bottles. About 38,952 bottles were distributed nationwide.

    Product
    TIZANIDINE — TIZANIDINE (TIZANIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0655-2024·2024-01-17

    Abiomed Introducer Kits Recalled for Sterile Barrier Pouch Defect

    Abiomed is recalling 84 introducer kits that may have holes in the outer pouch, compromising the sterile barrier. This exposes patients to microbial contamination and risk of serious infections including bacteremia and sepsis.

    Product
    Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 2000342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0689-2024·2024-01-17

    Olympus Updates Manual Cleaning Instructions for Cysto-Nephro Videoscope

    Olympus has updated cleaning instructions for the Model CYF-VH Cysto-Nephro Videoscope. Reusable cleaning brushes are no longer recommended for manual cleaning; single-use brushes remain compatible.

    Product
    Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0673-2024·2024-01-17

    Boston Scientific ZOOM LATITUDE Pacemaker Programmer Software Displays Incorrect Diagnostic Dates

    Boston Scientific is recalling pacemaker programmer software that displays certain diagnostic dates incorrectly, with dates showing years in the 1990s. Affected diagnostic information may impact clinical monitoring.

    Product
    Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0678-2024·2024-01-17

    Gamma Camera Gap Creates Extremity Entrapment Hazard During Quality Assurance

    Philips BrightView X gamma cameras may create a gap between patient support and detector during quality assurance scans, potentially trapping a patient's extremity.

    Product
    BrightView X, Gamma Camera, Product Code 882478
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0699-2024·2024-01-17

    Medtronic Percutaneous Pins Recalled for Potential Fitting and Removal Issues

    Medtronic is recalling 4,224 REF 9733236 percutaneous pins due to a manufacturing defect that may prevent proper fitting or cause difficult removal. Affected devices were distributed worldwide.

    Product
    Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0700-2024·2024-01-17

    VADER pedicle system torque wrench may not tighten implant screws correctly

    Icotec Ag is recalling VADER pedicle system torque wrenches (Catalog Number 42-702) because the torque limiting function may malfunction, potentially leaving nut screws insufficiently tightened during implant surgery. No injuries have been reported.

    Product
    VADER pedicle system, torque wrench, Catalog Number 42-702
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Drugs)·D-0222-2024·2024-01-17

    FDA recalls Bupropion Hydrochloride tablets for foreign tablet contamination

    Rising Pharma Holdings is recalling 47,976 bottles of Bupropion Hydrochloride 150mg tablets nationwide due to foreign tablets or capsules found in some bottles. Consumers should stop use and contact their pharmacist immediately.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0680-2024·2024-01-17

    Abbott Alinity i Processing Module Recalled for Unlabeled Latex Subcomponent

    Abbott Laboratories is recalling 1,325 Alinity i Processing Module systems due to unlabeled dry natural rubber (latex) subcomponents. Users with latex allergies may be at risk of exposure.

    Product
    Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology.…
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0647-2024·2024-01-17

    Abiomed Oscor Introducer Kit Recalled Due to Sterile Barrier Compromise

    Abiomed is recalling its Oscor Introducer Kit due to holes in the outer pouch that may compromise the sterile barrier. Non-sterile introducers could expose patients to infection, bacteremia, or sepsis.

    Product
    Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3014
    Category
    Medical Device
    Distribution
    Distributed nationwide