The Recall Desk
HighFDA (Devices)·Z-0386-2022·Announced 2021-12-22

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.

What this means for you

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.
Hazard
  • inaccurate-measurement
  • treatment-planning-error

Distribution

Distributed in 43 states:

  • 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
  • SC
  • SD
  • TN
  • TX
  • UT
  • VA
  • VT
  • WA
  • WI
  • WV