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FDAOctober 31, 2022device

Alcon Custom Pak Surgical Procedure Pack

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

The hazard

Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots.

What to do

FDA enforcement status: Ongoing

Brands named

alcon researchalcon

Recall history

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

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Alcon Custom Pak Surgical Procedure Pack — Recall Details · AllClear