# FDA recall Z-2324-2021

> **Ortho8, Inc.** · Class II · device recall initiated 2021-07-09.

## Product

CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,

## Reason for recall

CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance

## Distribution

US Nationwide distribution in the states of Al, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MO, NC, NV,  NJ, NY, OK, PA, SC, TN, TX, UT, VA.

## Key facts

- **Recall number:** Z-2324-2021
- **Recalling firm:** Ortho8, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-07-09
- **Report date:** 2021-08-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rocklin, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2324-2021

## Citation

> AI Analytics. FDA recall Z-2324-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2324-2021. Source: US FDA. Licensed CC0.

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