FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: EndoVive Safety PEG Kits 24 F Universal Product Number (UPN): MOO56648 1 The product provides nutrition directly into the stomach of adult and pediatric patients who are unable to consume by conventional methods.
- Recall number
- Z-2236-2008
- Recalling firm
- Boston Scientific Corporation
- Product
- EndoVive Safety PEG Kits 24 F Universal Product Number (UPN): MOO56648 1 The product provides nutrition directly into the stomach of adult and pediatric patients who are unable to consume by conventional methods.
- Status
- Terminated
- Initiated
- 2008-06-17
- Posted
- 2008-09-17
- Terminated
- 2008-12-10
- Reason
- Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG
- Root cause
- Labeling mix-ups
- Action
- Boston Scientific notified customers by priority Express Mail on June 17, 2008. The notification instructs accounts to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Contact Boston Scientific Corporation at 1-800-272-3737 for assistance.
- Quantity
- 16 Kits (total number of Kits)
- Distribution
- NJ, SC, TN, VA, and WI
- Lot, serial or model codes
- Lot Number: 11712923
- 510(k) numbers
- ["K030855"]
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 3001451463
- Firm city
- Natick
- Firm state
- MA
- 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