ACMI CORPORATION ACMI REF E-9F Electrohydraulic Lithotripsy Probe, 9 FR x 60CM Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ACMI REF E-9F Electrohydraulic Lithotripsy Probe, 9 FR x 60CM
Brand
ACMI CORPORATION
Lot Codes / Batch Numbers
Lot Numbers: 115823D to 1283724C
Products Sold
Lot Numbers: 115823D to 1283724C
ACMI CORPORATION is recalling ACMI REF E-9F Electrohydraulic Lithotripsy Probe, 9 FR x 60CM due to Product sterility may be compromised due to the lack of package seal integrity. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product sterility may be compromised due to the lack of package seal integrity
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026