activforce 2 package labeling: Model: Activ5-M R 201-200563 — Class II medical device recall Z-0386-2022
Ongoing recall by Activbody, Inc., reported 2021-12-22, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lea
| Recall number | Z-0386-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Activbody, Inc., San Diego, CA, United States |
| Recall initiated | 2021-11-30 |
| Classified | 2021-12-16 |
| Reported by FDA | 2021-12-22 |
| Distributed | 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, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Quantity | 145 kits |
| Serial numbers | 5M101, 5M1011012046AK7556, 5M1011012046AK7557, 5M1011012046AK7559, 5M1011012046AK7560, 5M1011012046AK7561, 5M1011012046AK7562, 5M1011012046AK7563, 5M1011012046AK7564, 5M1011012046AK7565, 5M1011012046AK7566, 5M1011012046AK7567, 5M1011012046AK7568, 5M1011012046AK7569, 5M1011012046AK7570, 5M1011012046AK7571, 5M1011012046AK7572, 5M1011012046AK7573, 5M1011012046AK7574, 5M1011012046AK7575, 5M1011012046AK7576, 5M1011012046AK7577, 5M1011012046AK7578, 5M1011012046AK7579, 5M1011012046AK7580 and 475 more |
| Model numbers | 201-200563, ACTIV5-MR |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0386-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.