Z-0243-2023Class II

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

Name: Z-0243-2023 EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in...
Creator: Altimate Medical, Inc.
Published: 2022-10-04
License: https://open.fda.gov/license/

Altimate Medical, Inc. / initiated 2022-10-04 / Terminated / root cause: manufacturing process

FDA source

Altimate Medical, Inc. began a recall of EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing on 2022-10-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0243-2023
Classification: Class II
Status: Terminated
Initiated: 2022-10-04
Posted: 2022-11-16
Terminated: 2023-08-31
Recalling firm: Altimate Medical, Inc.
Product: EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.
Product code: INO Chair, Positioning, Electric
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.
Root cause tag: manufacturing process
FDA root cause: Pending
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.
Quantity in commerce: 14 devices
Distribution: Worldwide - US distribution in the states of CA, CT, FL, LA, MI, TN, TX and the country of Canada.
Product codes and lots: a. UDI: (01)10858921006062(21)V2005693010, (01)10858921006062(21)V2005693012, (01)10858921006062(21)V2005693015, (01)10858921006062(21)V2005693017, (01)10858921006062(21)V2005694003, (01)10858921006062(21)V2005694009, (01)10858921006062(21)V2005694020, (01)10858921006062(21)V2005695010, (01)10858921006062(21)V2005695011, (01)10858921006062(21)V2005695018, (01)10858921006062(21)V2005695019, (01)10858921006062(21)V2005695020; b. UDI: (01)10858921006079(21)V1005700003, (01)10858921006079(21)V1005700009

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0243-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0243-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-23	2022-11-16

Product code INO

K091242Class IIBantamAltimate Medical, Inc. / cleared 2009-07-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)