FDA Medical Device Recalls (openFDA)
Power Medical Interventions: SurgASSIST System. Circular Stapler DLU 29 mm (product code CS29)
- Recall number
- Z-1048-03
- Recalling firm
- Power Medical Interventions
- Product
- SurgASSIST System. Circular Stapler DLU 29 mm (product code CS29)
- Status
- Terminated
- Initiated
- 2003-06-30
- Posted
- 2003-07-24
- Terminated
- 2004-03-16
- Reason
- latching mechanism failure
- Root cause
- Other
- Action
- The recalling firm issued a recall letter dated 6/30/03 to their accounts informing them of the recall and the need to return the product.
- Quantity
- 4211 units
- Distribution
- The products were shipped to medical facilities and sales representatives nationwide. The products were also shipped to distributors in Belgium, Germany, Ireland, Israel, Italy, Japan, Netherlands, and Spain
- Lot, serial or model codes
- Lot numbers DS-000036, DS-000043, DS-000047, DS-000049, DS-000052, DS-000055, DS-000057, DS-000061, DS-000064, DS-000072, DS-000073, DS-000077, DS-000078, DS-000082, DS-000084, DS-000085, DS-000086, DS-000090, DS-000095, DS-000099, DS-000117, DS-000118, DS-000119, DS-000126, DS-000132, DS-000133, DS-000135, DS-000138, DS-000140, DS-000141, DS-000145, LC-000022, LC-000023, LC-000024, LC-000030, LC-000044, LC-000052, LC-000053, LC-000055, LC-000056, LC-000061, LC-000066, LC-000068, and LC-000074.
- 510(k) numbers
- ["K003277"]
- PMA numbers
- not on file
- Product code
- GAG
- 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