FDAApril 21, 2026device

Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU

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

The hazard

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

What to do

FDA enforcement status: Ongoing

Brands named

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UPCs

108019022031721080190219327510801902221084108019022163941080190221501410801902217261

Recall history

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

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Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU — Recall Details · AllClear