RegWardenFDA facility compliance records
Company

PRO-DEX, INC.

5 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2015: 1 recalls; 2018: 1 recalls; 2023: 2 recalls; 2024: 1 recalls1201520162017120182019202020212022220231202420252026
  • Recalls (5)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2024-09-23
    The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
  • Class IIOngoing2023-02-15
    Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be prematurely expired.
  • Class IIOngoing2023-02-14
    Incorrect Unique Device Identifier/GTIN code was used on product.
  • Class IITerminated2018-09-25
    Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
  • Class IITerminated2015-12-23
    The sterile battery may contain particulates within the sterile package.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “PRO-DEX, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-2081135-pro-dex-inc/

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