FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific Radial Jaw Large Capacity Biopsy Forceps, Sterile, 240 mm. Box of 20 U PN Number: M00513321 REF: 1332-20
- Recall number
- Z-0116-2008
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific Radial Jaw Large Capacity Biopsy Forceps, Sterile, 240 mm. Box of 20 U PN Number: M00513321 REF: 1332-20
- Status
- Terminated
- Initiated
- 2007-08-28
- Posted
- 2007-10-31
- Terminated
- 2008-07-10
- Reason
- Device lacked manufacturing finishing process resulting in endoscope damage.
- Root cause
- Process control
- Action
- Boston Scientific notified accounts by letter on 8/28/07 by Federal Express Priority mail. Accounts are requested to remove product from inventory and return product.
- Quantity
- 145 boxes
- Distribution
- Worldwide, including USA, Sweden, and South Africa.
- Lot, serial or model codes
- Lot Number: 8990184
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FFF
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- 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