FDAJuly 14, 2025device
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
What to do
FDA enforcement status: Ongoing
Brands named
american contract systemsamericanamerican contract
UPCs
0019107219483100191072194930
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAOctopus Evolution AS Tissue Stabilizer, Model TS25002026-05-12
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- FDAOctopus 4 Tissue Stabilizer, Model 294002026-05-12
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