Z-0252-04

SurgAssist System Circular Stapler DLU 29mm

Name: Z-0252-04 SurgAssist System Circular Stapler DLU 29mm
Creator: Power Medical Interventions
Published: 2003-11-20
License: https://open.fda.gov/license/

Power Medical Interventions, Inc. / initiated 2003-11-20 / Terminated

FDA source

Power Medical Interventions began a recall of SurgAssist System Circular Stapler DLU 29mm on 2003-11-20. The reason FDA records is "improper staple formation or anvil jam". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0252-04
Status: Terminated
Initiated: 2003-11-20
Posted: 2003-12-19
Terminated: 2004-02-10
Recalling firm: Power Medical Interventions, Inc.
Product: SurgAssist System Circular Stapler DLU 29mm
Product code: GWD Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
Reason for recall: improper staple formation or anvil jam
FDA root cause: Other
Action: On 11/20/03, the recalling firm sent recall notices via overnight carrier to all customers who have been shippped and/or sold the product. The recall notice requested the return of the devices.
Quantity in commerce: 1164 units
Distribution: The products were shipped to medical facilities and sales representatives nationwide. The product was also shipped to distributors in the United Kingdom, France, Scotland, Belgium, Germany, Israel, Italy, Japan, Spain, Portugal, and Sweden.
Product codes and lots: Product Code CS29, Lot numbers LC-000125, LC000126, LC-000127, LC-000131, LC-000132, LC-000133, LC-000137, LC-000139, LC-000139-1, LC-000142, and LC-000143.

Product code GWD

K032701Class IISurgassist Circular Stapler Digital Loading Units (Cs21, Cs25, Cs29, Cs33)Power Medical Interventions, Inc. / cleared 2003-09-30

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)