FDASeptember 23, 2024device

KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000

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

The hazard

The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.

What to do

FDA enforcement status: Ongoing

Brands named

pro dexpropro dex

UPCs

008564820081221085648200812900856482008115

Recall history

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

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