Spes Medica 10 Fr Catheter Electrode Recall: Sterilization Risk
Spes Medica recalls 10 Fr urethral catheter electrodes due to possible sterilization process deviations. Affected units have reference number UE006 and lot UR20F2702I. No remedy specified in official notice.
Recall notice
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Contact the company
What happened, in plain English
Spes Medica is recalling 10 Fr disposable urethral catheter electrodes that may have been improperly sterilized. This could lead to infections or other health risks if used. The recall affects specific model units with reference number UE006 and lot UR20F2702I. Read more at govinfonow.com/recall/62814-spes-medica-10-fr-catheter-electrode-recall-sterilization-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62814-spes-medica-10-fr-catheter-electrode-recall-sterilization-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1968-2021
Cite this page
“Spes Medica 10 Fr Catheter Electrode Recall: Sterilization Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62814-spes-medica-10-fr-catheter-electrode-recall-sterilization-risk. Based on FDA recall #Z-1968-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1968-2021%22&limit=1).
Why it’s dangerous
The supplier reported possible deviations in the ethylene oxide sterilization process. This could mean the catheters weren't properly sterilized, increasing infection risk during medical procedures.
Who’s affected
Medical professionals and patients using the recalled catheter electrodes are affected. Those with the specific reference number UE006 and lot UR20F2702I are most at risk.
How to tell if you have this one
Check for the reference number UE006 and lot number UR20F2702I on the catheter packaging. The product is a 10 Fr disposable urethral catheter electrode with a gold recording/stimulating contact printed on polyurethane film.
- Brand
Spes Med: 10 Fr Catheter Electrode- Category
Medical device
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Distribution in the following US states: CA, MA, and SC.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1967-2021 | 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.; Lot LS20G3274I | 20 boxes |
| Z-1968-2021 | 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; Lot UR20F2702I | 34 boxes |
| Z-1969-2021 | 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.; Lot LS20E2538I and 110320C | 8 boxes |
| Z-1970-2021 | 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; Lot UR20F2699I | 30 boxes |
| Z-1971-2021 | Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.; Lot SI20F2956I | 3 boxes |
What to do — step by step
Check Product Details
Look for reference number UE006 and lot number UR20F2702I on the catheter packaging.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “Distribution in the following US states: CA, MA, and SC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Massachusetts, South Carolina.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1968-2021 (April 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1968-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.