The Concerto Basic Shower Trolley is intended for assisted hygiene… — Class II medical device recall Z-1388-2016
Terminated recall by Arjo, Inc. dba ArjoHuntleigh, reported 2016-04-20, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism beco
| Recall number | Z-1388-2016 |
|---|---|
| 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 | 2015-12-21 |
| Classified | 2016-04-13 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2018-06-25 |
| Distributed | AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, HK, HU, IE, IS, IT, JP, LT, NG, NL, NO, NZ, PL, PT, SA, SE, SG, SI, TW, ZA |
| Quantity | 1,596 units |
Product
The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments such as senior/assisted living, group home, special care, nursing homes, hospitals and home care. The Concerto Basic Shower Trolley is intended for indoor use.
Reason for recall
Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose.
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-1388-2016. 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.