Synaptic Corp Synaptic 3600 and 3800 with Cranial Electrical Stimulation manufactured by Synaptic USA, Aurora, CO. Transcutaneous nerve stimulation for pain relief and other medical treatment uses. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Synaptic 3600 and 3800 with Cranial Electrical Stimulation manufactured by Synaptic USA, Aurora, CO. Transcutaneous nerve stimulation for pain relief and other medical treatment uses.
Brand
Synaptic Corp
Lot Codes / Batch Numbers
Synaptic 3600 and 3800 with cranial electrical stimulation, all codes and lots.
Products Sold
Synaptic 3600 and 3800 with cranial electrical stimulation, all codes and lots.
Synaptic Corp is recalling Synaptic 3600 and 3800 with Cranial Electrical Stimulation manufactured by Synaptic USA, Aurora, CO. due to Device was distributed without marketing approval.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Device was distributed without marketing approval.
Recommended Action
Per FDA guidance
Synaptic Corp, sent a Urgent Medical Device Recall letter dated July 14th, 2008, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. The customer was instructed to return your 3600 and or 3800 devices so that the cranial stimulator can be removed and destroyed. Please call 1-800-685-7246 to schedule pick up of your device.. Complete the enclosed Confirmation Form and return it ( postage paid) to Synaptic Corp. It is important that you return the attached response confirmation form even if you do not have the (CES) module in your model. Should you have any questions about this recall please call 1-800-685-7246 ext. 101.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026