Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0243-2023 · Posted 2022-11-16

Recalling FirmAltimate Medical, Inc.
Recall StatusTerminated
Product CodeINO
Date Initiated2022-10-04
Date Terminated2023-08-31
Product Quantity14 devices

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.

Firm Action

Altimate Medical notified consignees via email on about 10/04/2022. The email contained a letter which instructed consignees to examine unit on hand to determine if it is affected, contact Customer Service if assistance is needed determining if unit is affected, cease distribution or use of affected device, replace bracket and confirm unit is corrected and functioning properly by returning the provided verification document.

Root Cause

Pending

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091242BANTAMAltimate Medical, Inc. · 2009-07-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑