Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5… — Class II medical device recall Z-0385-2022
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-0385-2022 |
|---|---|
| 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 | 501 kits |
| Serial numbers | 5P1011011708AB0000, 5P1011011708AB0001, 5P1011011708AB0002, 5P1011011708AB0003, 5P1011011708AB0004, 5P1011011708AB0005, 5P1011011708AB0006, 5P1011011708AB0007, 5P1011011708AB0008, 5P1011011708AB0009, 5P1011011708AB0010, 5P1011011708AB0011, 5P1011011708AB0012, 5P1011011708AB0013, 5P1011011708AB0014, 5P1011011708AB0015, 5P1011011708AB0016, 5P1011011708AB0017, 5P1011011708AB0018, 5P1011011708AB0019, 5P1011011708AB0020, 5P1011011708AB0021, 5P1011011708AB0022, 5P1011011708AB0023, 5P1011011708AB0024 and 475 more |
| Model numbers | ACTIV5 |
Product
Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first isometrics-based smart strength training and rehabilitation device.
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-0385-2022. 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.