Arjo Sara Plus Patient Lifter Recalled for Exposed Metal Bracket Injury Risk
ArjoHuntleigh is recalling Sara Plus Mobile Patient Lifters because removing the knee pad assembly exposes a metal support bracket, posing an injury risk.
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: The recall involves a medical device with reported injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has been reported but the hazard is specific to a particular configuration (knee pad removal).
Plain-English summary
Arjo, Inc. dba ArjoHuntleigh is recalling the Sara Plus Mobile Patient Lifter, models HEP0001-US and HEP1001-US. The device is a standing and raising aid used for short transfers, such as raising a patient from a bed to a wheelchair or from a wheelchair to a toilet.
The recall is due to a limited number of customer reports concerning injuries related to an exposed metal support bracket. This hazard occurs when the proactive knee pad assembly is removed from the device.
Approximately 2,480 units are affected in the United States, with an additional 2,651 units distributed in other countries. The affected units are identified by specific serial numbers listed in the official recall notice. Consumers should check their device's serial number against the recall list and contact ArjoHuntleigh for instructions on how to proceed.
The recalled product
- Product
- Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US and HEP1001-US. The Sara Plus is a standing and raising aid for short transfers e.g. raising from bed and transfer to wheelchair…
- Manufacturer
- Arjo, Inc. dba ArjoHuntleigh
- Category
- Medical Device — Patient Lifter
- Hazard
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 (20)
- Models HEP0001-US
- serial numbers SPSN0808U285
- PN1010U507
- PN1102U092
- PN1102U110
- SPSN0905U022
- SPSN0907U048
- SPSN0909U091
- SPSN0605U388
- SPSN0810U506
- PN1102U093
- PN1102U101
- PN1102U112
- PN1104U199
- PN1104U201
- PN1104U203
- PN1104U214
- PN1104U215
- PN1104U216
- PN1104U217
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Arjo, Inc. dba ArjoHuntleigh under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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