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FDAAugust 5, 2025device

Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA HP...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Due to incomplete seals in the pouch which provide the sterile barrier.

What to do

FDA enforcement status: Ongoing

Brands named

alcon researchalcon

UPCs

0038065000356000380650003584003806500035910038065000467300380650004680

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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