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U.S. Department of Health and Human Services

Class 2 Device Recall EasyStand Bantam

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 Class 2 Device Recall EasyStand Bantamsee related information
Date Initiated by FirmOctober 04, 2022
Date PostedNovember 16, 2022
Recall Status1 Terminated 3 on August 31, 2023
Recall NumberZ-0243-2023
Recall Event ID 91002
510(K)NumberK091242 
Product Classification Chair, positioning, electric - Product Code INO
ProductEasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.
Code Information 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
FEI Number 2183634
Recalling Firm/
Manufacturer		 Altimate Medical, Inc.
262 W 1st St
Morton MN 56270-1179
For Additional Information Contact
507-697-6393
Manufacturer 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.
FDA Determined
Cause 2		Pending
ActionAltimate 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 Commerce14 devices
DistributionWorldwide - US distribution in the states of CA, CT, FL, LA, MI, TN, TX and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = INO
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