Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 20, 2016
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.
Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose.
Arjo, Inc. dba ArjoHuntleigh recalled The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showe… - a moderate-severity action.
The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showe… was recalled by Arjo, Inc. dba ArjoHuntleigh in April 20, 2016. Reason: Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism bec…. Check the official notice for the remedy. Verify recall #Z-1388-2016 with the FDA Devices before acting.
The recall
Arjo, Inc. dba ArjoHuntleigh issued this moderate-severity FDA Devices recall-Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism bec….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- April 20, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1388-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1388-2016) was formally reported on April 20, 2016, with the manufacturer initiating the action on December 21, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Arjo, Inc. dba ArjoHuntleigh is listed as the recalling firm, operating out of Addison, IL. Federal records list the affected scope as 1,596 units.
The documented reason for this recall is: Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose. Distribution data in the federal record shows the product reached: US Consignees; 222 units distributed in the following states: 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 and WV. ***Foreig…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,596 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1388-2016 |
| Date reported | April 20, 2016 |
| Date initiated | December 21, 2015 |
| Recalling firm | Arjo, Inc. dba ArjoHuntleigh |
| Firm location | Addison, IL |
| Affected scope | 1,596 units |
| Distribution | US Consignees; 222 units distributed in the following states: 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 and WV. ***Foreign Consignees; 1374 u… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1388-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Arjo, Inc. dba ArjoHuntleigh. Units affected: 1,596 units.
Why was this product recalled? ▼
Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 20, 2016. Severity: Moderate. Recall number: Z-1388-2016.
Where was the recalled product distributed? ▼
Distribution: US Consignees; 222 units distributed in the following states: 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 and WV. ***Foreign Consignees; 1374 units distributed in the following countries: Australia, Austria, Belgium, Bosnia & Hercegovina, Brazil, CANADA, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Iceland, Ireland, Italy, Japan, Lithuania, Luxemburg, Netherlands, New Zealand, Nigeria, Norway, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan and UK..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1388-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 20, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.