FDA Medical Device Recalls (openFDA)
Power Medical Interventions: SurgAssist System Circular Stapler DLU 33mm
- Recall number
- Z-0253-04
- Recalling firm
- Power Medical Interventions
- Product
- SurgAssist System Circular Stapler DLU 33mm
- Status
- Terminated
- Initiated
- 2003-11-20
- Posted
- 2003-12-19
- Terminated
- 2004-02-10
- Reason
- improper staple formation or anvil jam
- 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
- 350 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.
- Lot, serial or model codes
- Product Code CS33, Lot numbers LC-000134, LC-000135, LC-000136, LC-000140, and LC-000144.
- 510(k) numbers
- ["K032701"]
- PMA numbers
- not on file
- Product code
- GWD
- Firm FEI
- 3003171713
- Firm city
- New Hope
- Firm state
- PA
- 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