FDA Medical Device Recalls (openFDA)
Banyan Medical, LLC: Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laproscopic Use- Sterile Single Use Only. Product Code 400-008
- Recall number
- Z-0074-2017
- Recalling firm
- Banyan Medical, LLC
- Product
- Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laproscopic Use- Sterile Single Use Only. Product Code 400-008
- Status
- Terminated
- Initiated
- 2016-09-07
- Posted
- not on file
- Terminated
- 2021-03-09
- Reason
- Potential lack of assurance of sterility
- Root cause
- Process control
- Action
- Banyan Medical issued Urgent Voluntary Recall Notification on 9/7/16 to Distributors to remove product from inventory and contact hospital to examine and return product. Questions contact your local Banyan Sales Representative
- Quantity
- 19 boxes of 5
- Distribution
- IN, TN
- Lot, serial or model codes
- Lot Numbers: 140310, 140806
- 510(k) numbers
- ["K133375"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 3009770724
- Firm city
- Warwick
- Firm state
- RI
- 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