NDO Surgical, Inc. Plicator EPS Plication System Catalog Number: 160-01128R Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Plicator EPS Plication System Catalog Number: 160-01128R
Brand
NDO Surgical, Inc.
Lot Codes / Batch Numbers
Serial Numbers: 43, 52, 54, 59, 63, 65, 68, 72, 96
Products Sold
Serial Numbers: 43, 52, 54,59, 63, 65, 68, 72, 96,
NDO Surgical, Inc. is recalling Plicator EPS Plication System Catalog Number: 160-01128R due to Device arm may fail to open after being deployed and require surgical intervention to remove. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Device arm may fail to open after being deployed and require surgical intervention to remove
Recommended Action
Per FDA guidance
NDO Surgical notified accounts by letter on 1/26/07 advising to quarantine units. Replacement units are being sent and recalled devices are requested to be returned.
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
AZ, GA, NH, NY, TN
Page updated: Jan 10, 2026