Activforce 2 force measurement device recalled for inaccurate measurement
Activforce 2 medical devices (145 units) are being recalled due to a manufacturing defect causing inaccurate force measurement, which may lead to incorrect treatment planning. Verify your device's serial number against the FDA recall list.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with risk of harm (inaccurate force measurement potentially leading to incorrect treatment planning) but no reported illnesses, injuries, or hospitalizations. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High.
Plain-English summary
Activforce 2 medical devices (Model Activ5-M R 201-200563), manufactured by Activbody, Inc., are being recalled. The recall affects 145 kits distributed across the United States and Puerto Rico.
The recall is due to a manufacturing issue that results in inaccurate force measurement. This inaccuracy may lead to incorrect treatment planning for patients using the device.
Users should verify their device's serial number against the FDA recall notice to determine if their device is affected and contact the manufacturer for instructions regarding replacement, return, or other remedial actions.
The recalled product
- Product
- activforce 2 package labeling: Model: Activ5-M R 201-200563
- Manufacturer
- Activbody, Inc.
- Affected units
- 145
Distribution
Part of a larger recall action
This product is one of 2 recalled by Activbody, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Activbody, Inc.
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FDA (Devices) · 2021-12-22
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