Recall Z-0315-2027— ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Class II · Ongoing
Class II FDA medical device recall by ARJOHUNTLEIGH POLSKA Sp. z.o.o., initiated 2026-09-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Carevo, Height-adjustable shower trolley, Model Number BAC1111-01. 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..
- Recalling firm
- ARJOHUNTLEIGH POLSKA Sp. z.o.o.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-09-25
- Firm location
- Komorniki, Poland
Product description
Carevo, Height-adjustable shower trolley, Model Number BAC1111-01
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.