The Recall Desk

Hazard

Improper Use recalls

66 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
66
Critical
1
Severe
2
Most recent
2026-05-06

Of the 66 improper use recalls we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (3%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all improper use recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 66

  • ModerateFDA (Devices)·Z-1949-2026·2026-05-06

    Genius Review Station Display Modified Outside Validated Configuration

    Hologic is correcting Genius Review Station displays (model CMP-01669) that were modified by users outside the FDA-cleared configuration. The devices need restoration to validated settings per the manufacturer's Operator's Manual.

    Product
    Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1910-2025·2025-06-11

    ChannelCheck Convenience Pack Pre-filled Water Syringes Recalled

    Healthmark Industries is recalling ChannelCheck Convenience Pack Pre-filled Water Syringes (Models UCC-222CP and UCC-222-ESP) because contamination was found in duodenoscope samples linked to the syringes, which were improperly used outside their intended purpose.

    Product
    ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1909-2025·2025-06-11

    Pre-filled Water Syringe recalled for improper use contamination

    Healthmark Industries is recalling Pre-filled Water Syringes (Model SW-010-100 and SW-010) after duodenoscope contamination was linked to improper use of the syringes outside their intended purpose.

    Product
    Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1509-2025·2025-04-09

    BD Connecta Stopcocks Recalled for Non-U.S. Instructions Shipped to U.S. Market

    BD Connecta Luer-Lok 360 stopcocks were distributed with non-U.S. instructions for use. Healthcare facilities should verify they have the correct U.S. instructions before using affected lot numbers.

    Product
    BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressure monitoring.
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-0490-2025·2024-11-27

    Alcon anti-reflux valve tubing breakage recall due to improper use

    Alcon Research LLC is recalling its Custom-Pak anti-reflux valve tubing because breakage occurred from improper use, resulting in updated labeling requirements.

    Product
    a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0498-2025·2024-11-27

    Olympus Gastrointestinal Videoscope Drying Instructions Clarified

    Olympus is recalling 1,749 GIF-1TH190 gastrointestinal videoscopes to clarify drying procedures in the instructions for use after human errors were identified during evaluation.

    Product
    Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0027-2025·2024-10-16

    Tonsil tray kits recalled for containing component under improper use recall

    Windstone Medical Packaging recalls 642 kits of Aligned Medical Tonsil Trays because they contain Cardinal Health Salem Sump PVC tubes that are subject to a separate recall for improper use.

    Product
    Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0030-2025·2024-10-16

    Aligned Medical T and A Pack Recalled for Component Misuse Risk

    Windstone Medical Packaging is recalling Aligned Medical T and A Pack REF AMS11482 because it contains a component subject to a separate recall action for improper use.

    Product
    Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0028-2025·2024-10-16

    Aligned Medical Tonsil ENT Pack Recalled for Component Under Separate Recall

    Windstone Medical is recalling 894 Aligned Medical Tonsil ENT Packs containing Cardinal Health Salem Sump PVC tubes due to improper use concerns with a component under a separate recall action.

    Product
    Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0031-2025·2024-10-16

    Aligned Medical Tonsil Packs Recalled Due to Improper-Use Kit Component

    Windstone Medical Packaging is recalling Aligned Medical Tonsil Pack kits due to a component under recall for improper use. Approximately 180 packs were distributed nationwide.

    Product
    Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0029-2025·2024-10-16

    Aligned Medical Septo Pack recalled for containing component under FDA recall

    The Aligned Medical Septo Pack (AMS11480) is recalled because it contains a Cardinal Health Salem Sump PVC tube component that is subject to an FDA recall for improper use.

    Product
    Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3301-2024·2024-10-02

    Cardinal Health Recalls Salem Sump Stomach Tubes Due to Valve Breakage

    Cardinal Health is recalling Salem Sump Dual Lumen Stomach Tubes because the Anti-Reflux Valve may break due to improper use. Labeling changes were made to address the issue.

    Product
    (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888264945, Sterile; (c) CardinalHealth Salem Sump Dua
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3185-2024·2024-09-25

    Acceava Respiratory Strep A test kits recalled for unlicensed distribution

    Cypress Medical Products recalls Acceava Respiratory Strep A diagnostic test kits nationwide due to a classification error that caused them to be shipped to customers without proper licensing.

    Product
    Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3184-2024·2024-09-25

    BinaxNOW Respiratory Strep A Test Kits Shipped to Unlicensed Purchasers

    Cypress Medical Products is recalling BinaxNOW Respiratory Strep A Test Kits due to an inventory system error that resulted in shipment to customers without proper licensing to purchase medical devices.

    Product
    BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1466-2024·2024-04-10

    Covidien Auto Suture Blunt Tip Trocar Recalled for Seal Disengagement Risk

    Covidien Auto Suture Blunt Tip Trocar devices are recalled due to potential seal disengagement when using mesh products incorrectly with the device. This malfunction risk affects surgical procedures.

    Product
    Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0848-2024·2024-02-14

    Enteral Syringes Recalled for Incompatibility with Feeding Pumps

    Cardinal Health Monoject Enteral Syringes with ENFit connections are recalled due to compatibility issues with certain syringe feeding pumps. The manufacturer recommends they not be used with enteral syringe feeding pumps.

    Product
    Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0695-2024·2024-01-17

    SoClean 2 Supplemental Hose and Mask System Ozone Exposure Recall

    SoClean is recalling its SoClean 2 hose and mask maintenance system to reduce potential ozone gas exposure risks. An updated user manual and replacement adapter will be provided by the manufacturer.

    Product
    SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2535-2023·2023-09-20

    Procedural Kits with Ultrasonic Gel Recalled for Inappropriate Use Labeling

    Advance Medical Designs is recalling 117,875 procedural kits containing ultrasonic transmission gel due to mislabeling of use instructions. The recall affects kits distributed to the United States, Canada, United Kingdom, Panama, and Netherlands.

    Product
    Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0412-2023·2022-12-14

    Bipolar Surgical Forceps Recalled for Missing Instruction Manual Content

    CareFusion bipolar forceps recalled due to missing instructions on power supply interface and cleaning/maintenance procedures. Corrected documentation is now available.

    Product
    CareFusion V. Mueller Neuro/Spine TITANUIM BIPOLAR FORCEPS STRAIGHT, 0.25MM TIP OVERALL LENGTH 6" (150MM) , REF F-5128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2022·2022-07-27

    Spinal fixation removal key fracture risk under misuse conditions

    The ENNOVATE MIS removal key used in spinal fixation systems may fracture if the 90-degree angle is not maintained during use. A product redesign is underway.

    Product
    ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1394-2022·2022-07-27

    Triton Sponge System Software Instructions Updated for Proper Sponge Handling

    Stryker is updating the Instructions for Use for the Triton Sponge System software (versions 4.6.5, 4.8.7, 4.9.6) to clarify proper handling technique for sponges and calibration placard. The FDA Class III recall affects 51 units distributed nationwide.

    Product
    Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0825-2022·2022-03-30

    DigniCap Delta Scalp Cooling System instructions updated for headband use

    Dignitana updated instructions for the DigniCap Delta Scalp Cooling System to recommend headband use and warn about condensation risk in certain environmental conditions.

    Product
    DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20190325-06-EN), DigniCap Delta Scalp Cooling Wrap (LAB 20190221-05-EN), DigniCap Delta Small Cooling Wrap (LAB 20200616-01-EN,
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0244-2022·2021-11-24

    Bodycad Torque Limiting Adaptor Recalled for Breakage Risk

    Laboratoires Bodycad is recalling its Torque Limiting Adaptor AO Connect due to risk of breakage if used counterclockwise and lack of validation for power tool use. Approximately 10 units were distributed to facilities in Colorado, Michigan, and New York.

    Product
    Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2408-2021·2021-09-08

    FaStep COVID-19 Test Devices Recalled for Unauthorized Laboratory Distribution

    Versea Diagnostics recalled 563,290 FaStep COVID-19 antibody test devices that were distributed to laboratories not certified under federal standards. The devices were authorized only for use in CLIA-certified laboratories.

    Product
    FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2219-2021·2021-08-18

    Michael Graves Stryker Highback Chair distributed to home users instead of healthcare facilities

    Stryker Medical Division recalled its Michael Graves Highback Chair (Model 4853) after it was distributed to residential customers instead of healthcare facilities. Home users may not understand safety instructions written for trained medical professionals.

    Product
    Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model Number 4853, Part #4853000000 ¿
    Category
    Medical Device
    Distribution
    Distributed nationwide