CLASS II Device recall · Reported 20 Feb 2013 · FDA Enforcement Report
Foam Electrodes with Carbon construction recalled by NAImco
NAImco is recalling Foam Electrodes with Carbon construction, distributed in Georgia, Tennessee. The recall was initiated on 30 Nov 2009 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-0817-2013
- FDA event ID
- 63927
- Recalling firm
- NAImco, Chattanooga, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Nov 2009
- FDA classified
- 14 Feb 2013
- Reported
- 20 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 30 Nov 2009 | Recall initiated by company | |
| 14 Feb 2013 | Classified by FDA | +1172 days |
| 20 Feb 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
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
Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 203-678, and 400-856, 1.5" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1271, Cat Nos.: 201-127, 202-093, 203-483, 203-565, 203-673, and 400-873, 2" x 2" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1281, Cat Nos.: 201-128, 202-277, 203-675, and 400-873, 2" Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1291, Cat Nos.: 201-129, 203-677, and 400-882, 3" Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1301, Cat Nos.: 201-130, 203-679, and 400-855, 1.5" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1371, Cat Nos.: 201-137, 202-278, 203-484, 203-681, and 400-880, 2" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-5671, Cat No. 202-567, 2" x 2" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. Cutaneous electrode.
Where it was distributed
Distributed in the states of GA and TN.
Questions about this recall
Is Foam Electrodes with Carbon construction recalled?
Yes. NAImco recalled Foam Electrodes with Carbon construction on 30 Nov 2009. The recall is Class II and its status is Terminated. Recall number Z-0817-2013.
Why was it recalled?
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
Which lots are affected?
All Serial Numbers distributed between 11/01/2009 and 01/31/2010
Where was it sold?
Distributed in the states of GA and TN.
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 NAImco
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cloth electrodes with Carbon construction recalled by NAImco | NAImco | Lead & Heavy Metals | GA, TN |
| Device | CLASS II | Cloth electrodes with Silver-Carbon construction recalled by NAImco | NAImco | Lead & Heavy Metals | GA, TN |
| Device | CLASS II | Foam electrodes with Silver-Carbon construction recalled by NAImco | NAImco | Lead & Heavy Metals | GA, TN |
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