FDA Medical Device Recalls (openFDA)
ACMI CORPORATION: ACMI REF E-9F Electrohydraulic Lithotripsy Probe, 9 FR x 60CM
- Recall number
- Z-0928-04
- Recalling firm
- ACMI CORPORATION
- Product
- ACMI REF E-9F Electrohydraulic Lithotripsy Probe, 9 FR x 60CM
- Status
- Terminated
- Initiated
- 2004-04-30
- Posted
- 2004-07-20
- Terminated
- 2005-06-13
- Reason
- Product sterility may be compromised due to the lack of package seal integrity
- Root cause
- Other
- Action
- ACMI issued a recall letter dated 4/30/04 via Certified Mail. Users will be asked to return unused product. International Distributors were faxed letters notifying of them of the action.
- Quantity
- 951 boxes(6 probes/box)
- Distribution
- Nationwide Foreign: Canada, Australa, Brazil, Korea, Mexico, Turkey
- Lot, serial or model codes
- Lot Numbers: 115823D to 1283724C
- 510(k) numbers
- ["K980492"]
- PMA numbers
- not on file
- Product code
- FFK
- Firm FEI
- not on file
- Firm city
- Southborough
- 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