CLASS II Device recall · Reported 7 Jul 2021 · FDA Enforcement Report
SNS Disposable Urethral Catheter Electrode recalled by Spes Medica
Spes Medica is recalling SNS Disposable Urethral Catheter Electrode, Gold Recording/Stimulating Contact printed on, distributed in California, Massachusetts, South Carolina. The recall was initiated on 8 Apr 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1970-2021
- FDA event ID
- 87999
- Recalling firm
- Spes Medica, Genoa, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Apr 2021
- FDA classified
- 25 Jun 2021
- Reported
- 7 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Lead & Heavy Metals
- Device type
- Heart & Vascular Devices
Timeline
| 8 Apr 2021 | Recall initiated by company | |
| 25 Jun 2021 | Classified by FDA | +78 days |
| 7 Jul 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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
Where it was distributed
Distribution in the following US states: CA, MA, and SC.
Questions about this recall
Is SNS Disposable Urethral Catheter Electrode, Gold Recording/Stimulating Contact printed on recalled?
Yes. Spes Medica recalled SNS Disposable Urethral Catheter Electrode, Gold Recording/Stimulating Contact printed on on 8 Apr 2021. The recall is Class II and its status is Terminated. Recall number Z-1970-2021.
Why was it recalled?
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Which lots are affected?
Lot UR20F2699I
Where was it sold?
Distribution in the following US states: CA, MA, and SC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Spes Medica
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm) recalled | Spes Medica | Sterility | CA, MA, SC |
| Device | CLASS II | Tripolar Hooked Stimulation Probes, L= recalled by Spes Medica | Spes Medica | Sterility | CA, MA, SC |
| Device | CLASS II | Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm) recalled | Spes Medica | Sterility | CA, MA, SC |
| Device | CLASS II | SNS Disposable Urethral Catheter Electrode recalled by Spes Medica | Spes Medica | Lead & Heavy Metals | CA, MA, SC |
Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |