FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: TLC Retractor and Single Step Pelvic Drape (contains 1 Product Code 820-175) Product Code: 820-177
- Recall number
- Z-0259-06
- Recalling firm
- Boston Scientific Corporation
- Product
- TLC Retractor and Single Step Pelvic Drape (contains 1 Product Code 820-175) Product Code: 820-177
- Status
- Terminated
- Initiated
- 2005-10-25
- Posted
- 2005-12-01
- Terminated
- 2007-06-20
- Reason
- Sterility of device compromised due to breach in packaging
- Root cause
- Other
- Action
- Boston Scientific initiated the recall on October 25, 2005 to accouunts requesting the return of the product and completion of the Reply Verification Tracking Form.
- Quantity
- 310
- Distribution
- Nationwide
- Lot, serial or model codes
- All lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAD
- 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