Boston Scientific Corp Boston Scientific brand pull Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit, 20 Frl; catalog number 6838. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific brand pull Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit, 20 Frl; catalog number 6838.
Brand
Boston Scientific Corp
Lot Codes / Batch Numbers
Lots 7452729, 7448186, 7426909 and 7385202.
Products Sold
Lots 7452729, 7448186, 7426909 and 7385202.
Boston Scientific Corp is recalling Boston Scientific brand pull Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit, 20 Frl; ca due to Two blades may be heat staked onto the stiletto instead of the expected one blade.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Two blades may be heat staked onto the stiletto instead of the expected one blade.
Recommended Action
Per FDA guidance
Customers were notified by a recall letter dated 6/7/05 which instructed them to return any of the recalled products on hand.
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