The Recall Desk

Manufacturer

Spes Medica

5 recalls in our database name Spes Medica as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2021-07-07

Of the 5 recalls from Spes Medica we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • HighFDA (Devices)·Z-1971-2021·2021-07-07

    Tripolar Hooked Stimulation Probes recalled for ethylene oxide sterilization deviation

    Spes Medica is recalling Tripolar Hooked Stimulation Probes due to possible deviations in the ethylene oxide sterilization process. The affected devices were distributed to healthcare facilities in California, Massachusetts, and South Carolina.

    Product
    Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1968-2021·2021-07-07

    SNS Disposable Urethral Catheter Electrode Recalled for Sterilization Process Deviations

    Spes Medica is recalling SNS Disposable Urethral Catheter Electrodes due to possible deviations in the ethylene oxide sterilization process. The recalled units may not be adequately sterilized, posing a potential infection risk to users.

    Product
    SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE006
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1970-2021·2021-07-07

    SNS Disposable Urethral Catheter Electrode Recalled for Sterilization Process Deviations

    Spes Medica has recalled SNS Disposable Urethral Catheter Electrodes due to possible deviations in ethylene oxide sterilization processes. The recall affects one lot distributed in California, Massachusetts, and South Carolina.

    Product
    SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE002
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1969-2021·2021-07-07

    Dragonfly Laryngeal Electrode Recalled Due to Sterilization Process Issues

    Spes Medica is recalling Dragonfly Laryngeal Surface Electrodes due to possible deviations in ethylene oxide sterilization parameters. The affected lots are LS20E2538I and 110320C, distributed to select US states.

    Product
    Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG monitoring of the larynx during surgical procedures.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1967-2021·2021-07-07

    Dragonfly Laryngeal Surface Electrode recalled for sterilization process deviation

    Spes Medica is recalling Dragonfly Laryngeal Surface Electrodes due to possible deviations in ethylene oxide sterilization process. Affected lot LS20G3274I was distributed in California, Massachusetts, and South Carolina.

    Product
    Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous EMG monitoring of the larynx during surgical procedures.
    Category
    Medical Device
    Distribution
    3 states