Oscor, Inc. AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Brand
Oscor, Inc.
Lot Codes / Batch Numbers
GUDID: 25051684026298, Lot Number DP-11759
Products Sold
GUDID: 25051684026298; Lot Number DP-11759
Oscor, Inc. is recalling AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduc due to Potential for open seal on sterile product. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for open seal on sterile product
Recommended Action
Per FDA guidance
The firm notified their sole consignee of the recall by letter on 03/23/2021 as a written follow-up communication held on 03/10/2021 which requested the return of the recalled product.
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