Activbody recalls activforce 2 package labeling (model Activ5-M R 201-200563) 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 specific models of activforce 2 package labeling devices because they have manufacturing issues that can cause inaccurate force measurements. This might lead to incorrect treatment planning. The company also didn't register these devices with the FDA.
The devices have manufacturing issues that result in inaccurate force measurements. This could lead to incorrect treatment planning if used in medical settings. The company also failed to register these devices with the FDA, which is a regulatory issue but not an immediate safety risk.
People who own or use the specific activforce 2 package labeling models with serial numbers listed in the recall are affected. The risk is low because the issue is about measurement accuracy, not immediate safety hazards.
Check if your activforce 2 package labeling has the model number Activ5-M R 201-200563 and one of the serial numbers listed in the recall. The serial numbers are long alphanumeric codes starting with '5M1011012102AL' followed by numbers.
Look for the model number Activ5-M R 201-200563 and one of the serial numbers listed in the recall on your device.
Activbody is recalling these devices due to manufacturing issues that can cause inaccurate force measurements, which might lead to incorrect treatment planning. The company also failed to register these medical devices with the FDA.
If you have the specific model and serial numbers listed in the recall, you should check your device. The recall does not require immediate action beyond checking if your device is affected.
This is a low-risk issue related to measurement accuracy, not an immediate safety hazard. The company did not register the devices with the FDA, but this is a regulatory issue rather than a direct safety risk.
We’ve drafted a message you can send Activbody to request your refund or repair — edit it as you like.
Subject: Recall Z-0386-2022 — Activbody Activbody Hello, I own a Activbody that is covered by recall Z-0386-2022 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.
