Z-0118-2008

Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 40 UPN...

Name: Z-0118-2008 Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 40 UPN...
Creator: Boston Scientific Corporation
Published: 2007-08-28
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2007-08-28 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 40 UPN Number: M00513332 REF: 1333-40 on 2007-08-28. The reason FDA records is "Device lacked manufacturing finishing process resulting in endoscope damage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0118-2008
Status: Terminated
Initiated: 2007-08-28
Posted: 2007-10-31
Terminated: 2008-07-10
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 40 UPN Number: M00513332 REF: 1333-40
Product code: FFF Cover, Biopsy Forceps
Reason for recall: Device lacked manufacturing finishing process resulting in endoscope damage.
Root cause tag: manufacturing process
FDA 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 in commerce: 734 boxes
Distribution: Worldwide, including USA, Sweden, and South Africa.
Product codes and lots: Lot Numbers: 8984687, 8984688, 8984689, 8990186, 9003394, 9003396, 9005718, 9005719, 9017283

Product code FFF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)