Recall Z-0315-2027 ยท FSA Lift, Patient, Non-Ac-Powered
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Carevo, Height-adjustable shower trolley, Model Number BAC1111-01
| Date | Oct 29, 2026 (initiated Sep 25, 2026) |
| Status | Open, Classified |
| Reason | The side support of the shower trolley may open unintentionally when the handles are not fully locked and additional force is applied during patient handling. If the side support is not fully locked and an additional force is applied by the caregiver on the handle (e.g., during turning or repositioning), the panel may open unintentionally, which can lead to a resident/patient fall and serious injury, such as head injury, fractures, or other trauma resulting from a patient fall. |
| Root cause | Under Investigation by firm |
| Action | A FIELD SAFETY NOTICE dated 9/23/26 was sent to customers for Carevo shower trolley - side support opening by accident from outside of the device. Please review the following warnings carefully: 1. When the side panels snap into place, a characteristic "click" sound can be heard. 2. Ensure both latches on each side support are in the locked position. Failure to comply may result in unintentional side support opening while handling a patient/resident, posing their fall risk. Refer to picture 2. 3. Avoid hitting or pushing the side support handle with your thigh or knee when handling the patie |
| Quantity | 8780 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.