Encision, Inc. EM2M NC AEM Monitor, (NON-COM) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EM2M NC AEM Monitor, (NON-COM)
Brand
Encision, Inc.
Lot Codes / Batch Numbers
Catalog number EM2M NC, all serial numbers
Products Sold
Catalog number EM2M NC, all serial numbers
Encision, Inc. is recalling EM2M NC AEM Monitor, (NON-COM) due to Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.
Recommended Action
Per FDA guidance
Accounts were visited by sales representatives beginning 6/23/2003.
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 noticeDistribution
As reported by FDA
CA, IL, KS, OH, OK, OR, PA, TN
Page updated: Jan 10, 2026