# FDA recall Z-0386-2022

> **Activbody, Inc.** · Class II · device recall initiated 2021-11-30.

## Product

activforce 2 package labeling: Model: Activ5-M R 201-200563

## Reason for recall

Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration.

## Distribution

U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV.  O.U.S.: Not provided

## Key facts

- **Recall number:** Z-0386-2022
- **Recalling firm:** Activbody, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-11-30
- **Report date:** 2021-12-22

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0386-2022

## Citation

> AI Analytics. FDA recall Z-0386-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0386-2022. Source: US FDA. Licensed CC0.

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