Activbody recalls 1700+ Activ5 TINY GYM devices due to manufacturing issues causing inaccurate force measurements that could lead to incorrect treatment planning. The company also failed to register medical devices with the FDA.
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.
Activbody is recalling over 1,700 Activ5 TINY GYM devices because they may measure force incorrectly, which could lead to improper treatment planning. The company also didn't register these devices with the FDA as required.
The device has manufacturing issues that cause inaccurate force measurements. This could lead to incorrect treatment planning if used for rehabilitation or strength training. The company also failed to register these medical devices with the FDA.
Users of the Activ5 TINY GYM device are affected. The risk is low as the issue relates to potential treatment planning errors rather than immediate physical harm.
Check your Activ5 device for the model number starting with 'Activ5' and serial numbers listed in the recall (5P1011011708AB0000 to 5P1011011708AB1703).
Look for the model number starting with 'Activ5' and serial numbers between 5P1011011708AB0000 and 5P1011011708AB1703.
Activbody recalls these devices due to manufacturing issues that cause inaccurate force measurements, which could lead to incorrect treatment planning. The company also failed to register these medical devices with the FDA.
Your device is affected if it has the Activ5 model number and a serial number between 5P1011011708AB0000 and 5P1011011708AB1703.
The recall does not require immediate action beyond checking if your device is affected. Activbody has not provided a specific remedy for this issue.
We’ve drafted a message you can send Activbody to request your refund or repair — edit it as you like.
Subject: Recall Z-0385-2022 — Activbody Activbody Hello, I own a Activbody that is covered by recall Z-0385-2022 from Activbody. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
