Sara Plus Mobile Patient Lifter — Class II medical device recall Z-1949-2012
Terminated recall by Arjo, Inc. dba ArjoHuntleigh, reported 2012-07-18, distributed nationwide. ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed meta
| Recall number | Z-1949-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arjo, Inc. dba ArjoHuntleigh, Addison, IL, United States |
| Recall initiated | 2012-06-29 |
| Classified | 2012-07-06 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2018-03-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BM, CA, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HK, IE, IL, IS, IT, JP, KE, KR, LU, NL, NO, NZ, PL, PT, SA, SE, SG, SI, SK, TR |
| Serial numbers | P0106584, P0107317, P0107318, P0107319, P0107320, P0107321, P0107322, P0107323, P0107324, P0107325, P0107326, P0107327, P0107328, P0107329, P0107330, P0110043, P0110044, P0110045, P0110046, P0110047, P0110048, P0110049, P0110050, P0110051, P0110052 and 475 more |
| Model numbers | HEP0001-US, HEP1001-US |
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, or from wheelchair to toilet. Sara Plus is also suitable for walking training when the footboard and kneepad are removed.
Reason for recall
ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1949-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.