ACMI REF E-5F Electrohydraulic Lithotripsy Probe recallZ-0927-04 · Acmi Corporation · initiated Apr 30, 2004
Terminated All recalls posted in July 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Acmi Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product sterility may be compromised due to the lack of package seal integrity
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0927-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 30, 2004
- Posted by the FDA
- Jul 20, 2004
- Recalling firm
- Acmi Corporation
- Quantity
- 186 boxes ( 6 probes/box)
- Product code
- FFK
- FDA submissions
- K980492
- Distribution
- Nationwide Foreign: Canada, Australa, Brazil, Korea, Mexico, Turkey
Product description
ACMI REF E-5F Electrohydraulic Lithotripsy Probe, 5FR x 60CM
Code information (models, lots, serial numbers)
Lot Numbers: 1122733E to 1262504A
Other devices under the same FDA submission
1 device cleared under K980492 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Gyrus ACMI E-9FGyrus ACMI, LLC · Lithotriptor, electro-hydraulic1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 28975).
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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