FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 24 Fr, pull; catalog number 6824.
- Recall number
- Z-0965-05
- Recalling firm
- Boston Scientific Corp
- Product
- Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 24 Fr, pull; catalog number 6824.
- Status
- Terminated
- Initiated
- 2005-06-02
- Posted
- 2005-07-07
- Terminated
- 2006-12-13
- Reason
- Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Root cause
- Other
- Action
- Customers were notified by a recall letter dated 6/7/05 which instructed them to return any of the recalled products on hand.
- Quantity
- not on file
- Distribution
- Nationwide and Panama.
- Lot, serial or model codes
- Lot 7406777.
- 510(k) numbers
- ["K031538"]
- PMA numbers
- not on file
- Product code
- KGC
- Firm FEI
- 1828132
- Firm city
- Spencer
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28