FDA recall record · openFDA

Pro-Dex Inc

3 FDA recalls on record (2023–2024) — 3 device. 3 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Incorrect Unique Device Identifier/GTIN code was used on product. 1

The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the ster 1

Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have s 1

Recalls

KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin Ma Class II 2024-09-23 KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e Class II 2023-02-14 KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxD Class II 2023-02-15

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

Machine-readable: JSON-LD · Markdown