The Recall Desk

State

Delaware product recalls

72,940 recalls have nationwide distribution and so reach Delaware. 3,435 additional recalls listed Delaware specifically in their distribution scope.

What the numbers show

Total
3,435
Critical
477
Severe
937
Most recent
2026-09-09

Of the 3,435 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 937 (27%) are Severe.

Which agencies issued them

These figures cover only the 3,435 recalls whose distribution notice names Delaware specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5476–5500 of 76375

  • HighFDA (Devices)·Z-2452-2025·2025-09-03

    Surgery trays recalled because they contain recalled tourniquet cuffs

    Medline General Surgery Trays are recalled because they contain recalled Stryker Color Cuff tourniquet cuffs whose flange may detach, compromising air pressure and risking tourniquet failure. 1,145 units are affected.

    Product
    The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits will be assembled using
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2440-2025·2025-09-03

    Custom loupes with Dragonfly frames recalled over nickel nose pad allergy risk

    Orascoptic custom loupes with Dragonfly frames are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 15,245 units are affected.

    Product
    Orascoptic Superior Visualization Custom loupes with Dragonfly frames
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2025·2025-09-03

    Canal filling stems recalled after unidentified substance found during retrospective evaluation

    ELEOS Segmental Stem Canal Filling straight slotted splined 2/3 plasma implants are recalled because an unidentified substance of unknown impact was found on devices. 15 units are affected.

    Product
    ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2477-2025·2025-09-03

    Medication dispensing stations recalled because antivirus software was not consistently installed

    BD Pyxis MedStation and Anesthesia Station devices are recalled because antivirus software was not consistently installed during implementation. 8,353 devices are affected, 6,738 of them in the US.

    Product
    BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 327 BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2476-2025·2025-09-03

    Fibrinogen test kits recalled over potential cross-contamination in heparin assays

    STA-Fibrinogen 5 kits are recalled because of the potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in heparin applications. 829,800 units are affected, 245,200 of them in the US.

    Product
    STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2473-2025·2025-09-03

    Coagulation analyzers recalled over potential reagent contamination in anti-Xa testing

    STA Satellite analyzers are recalled because of the potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 3,650 units are affected.

    Product
    STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2419-2025·2025-09-03

    Light therapy devices recalled over welded nut that may shear off

    Two NovoTHOR Gen 3.0 Reg PRX units are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift.

    Product
    Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2417-2025·2025-09-03

    NovoTHOR XL devices recalled over failed welded nut detaching gas strut

    NovoTHOR XL devices, model S2190, are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift. 55 units are affected.

    Product
    Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2474-2025·2025-09-03

    Anti-Xa 4 test kits recalled over potential fibrinogen reagent contamination

    STA-Liquid Anti-Xa 4 kits are recalled because of the potential for contamination by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 116,600 units are affected.

    Product
    STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2475-2025·2025-09-03

    Anti-Xa test kits recalled over potential contamination by fibrinogen reagents

    STA-Liquid Anti-Xa 8 kits are recalled because of the potential for contamination by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 126,200 units are affected.

    Product
    STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2421-2025·2025-09-03

    Dental implant locating kits recalled over thread defect limiting full engagement

    Atlantis IO FLO-S Kits are recalled because a thread defect stops the device fully engaging an implant or analog, engaging about two rotations instead of five. 102 units are affected.

    Product
    Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure wit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2416-2025·2025-09-03

    NovoTHOR light therapy devices recalled over welded nut that may shear

    NovoTHOR devices, model S2188, are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift. 80 units are affected.

    Product
    Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2418-2025·2025-09-03

    NovoTHOR Gen 3.0 unit recalled because gas strut may detach from canopy

    A single NovoTHOR Gen 3.0 Reg PRX unit, model S2189, is recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift.

    Product
    Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2453-2025·2025-09-03

    Drug transfer devices recalled for shipping without US instructions for use

    BD PhaSeal closed system drug transfer devices are recalled because they were shipped to the US market without a US version of the instructions for use. 3,884,670 units are affected.

    Product
    BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005 BD PhaSeal Protector (P14), REF: 515100 BD PhaSeal Protector (P21), REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2422-2025·2025-09-03

    Atlantis IO FLO-S kits recalled over thread defect limiting implant engagement

    Atlantis IO FLO-S Kits, catalog A04S / 68020034, are recalled because a thread defect stops the device fully engaging an implant or analog, engaging about two rotations instead of five. 780 units are affected.

    Product
    Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring che
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2382-2025·2025-09-03

    L9-3 transducer probes recalled for labelling that defines useful life

    L9-3 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    L9-3 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2389-2025·2025-09-03

    S12-4 transducer probes recalled to clarify useful life in the field

    S12-4 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    S12-4 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2408-2025·2025-09-03

    X5-1 transducer probes recalled to clarify useful life in the field

    X5-1 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    X5-1 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2380-2025·2025-09-03

    L18-5 ultrasound transducer probes recalled to add useful life labelling

    L18-5 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    L18-5 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2386-2025·2025-09-03

    mL26-8 transducer probes recalled to add field useful life labelling

    mL26-8 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    mL26-8 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide