Facility

PRO-DEX, INC.

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

Key facts

5recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	2081135
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	2361 McGaw Avenue Irvine, CA, US 92614
Registration status	Active · expires 2026
Parent company	PRO-DEX, INC. (owner-operator 2081135)

Activity by year

Recalls (5)

Devices registered here (1)

Arthroscope
Product code HRX (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.1100

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. Verify this facility record at FDA → (opens in a new tab)

Cite this record

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

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