FDA Device recall Z-0385-2022
Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first isometrics-b…
- FDA Device
- Class II
- ongoing
- Published 2021-12-22
On 2021-12-22 the FDA classified a Class II recall of Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first isometrics-b… by Activbody, citing 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 li….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0385-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-30 |
| Published | 2021-12-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Activbody |
| Distribution | 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 |
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
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.
Identifiers
| code_info | Activforce Kit Number: AB0000-AC5540 Serial Numbers: 5P1011011708AB0000 5P1011011708AB0001 5P1011011708AB0002 5P1011011…Activforce Kit Number: AB0000-AC5540 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 5P1011011708AB0025 5P1011011708AB0026 5P1011011708AB0027 5P1011011708AB0028 5P1011011708AB0029 5P1011011708AB0030 5P1011011708AB0031 5P1011011708AB0032 5P1011011708AB0033 5P1011011708AB0034 5P1011011708AB0035 5P1011011708AB0036 5P1011011708AB0037 5P1011011708AB0038 5P1011011708AB0039 5P1011011708AB0040 5P1011011708AB0041 5P1011011708AB0042 5P1011011708AB0043 5P1011011708AB0044 5P1011011708AB0045 5P1011011708AB0046 5P1011011708AB0047 5P1011011708AB0048 5P1011011708AB00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0385-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.