FDA recall Z-0243-2023

Altimate Medical, Inc. · Class II · device

Product

EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.

Reason for recall

Some EasyStand Bantam Small and Extra Small standers with the non-supine option may have been manufactured with a component that affects the operation of the leg assembly bracket to maintain the standers non-supine position.

Distribution

Worldwide - US distribution in the states of CA, CT, FL, LA, MI, TN, TX and the country of Canada.

Key facts

Status
Terminated
Initiation date
2022-10-04
Report date
2022-11-23
Termination date
2023-08-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morton, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0243-2023