EasyStand Bantam standing devices may fail to maintain upright position
Altimate Medical is recalling EasyStand Bantam Small and Extra Small standers due to a component defect that may prevent the leg assembly bracket from maintaining the non-supine position. No injuries have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a risk-of-harm product (standing assistance device) where a mechanical defect could result in loss of support and potential falls. No injuries have been reported, placing this at High (score 3) per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Altimate Medical, Inc. is recalling certain EasyStand Bantam Small and Extra Small standing devices. The recall affects devices with the non-supine option.
Some of these devices may have been manufactured with a component that affects the leg assembly bracket's ability to maintain the non-supine position. This could result in the device failing to remain upright.
The recalled devices were distributed in California, Connecticut, Florida, Louisiana, Michigan, Tennessee, Texas, and Canada. Consumers who have affected devices should stop using them and contact Altimate Medical for a replacement or repair.
No injuries related to this issue have been reported.
The recalled product
- Product
- EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.
- Manufacturer
- Altimate Medical, Inc.
- Affected units
- 14
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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
Distribution
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