Class 2 Device Recall Carevo

• Date Initiated by Firm: September 25, 2026
• Date Posted: October 29, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0315-2027
• Recall Event ID: 99900
• Product Classification: Lift, patient, non-ac-powered - Product Code FSA
• Product: Carevo, Height-adjustable shower trolley, Model Number BAC1111-01
• Code Information: Serial Numbers: P0347696 P0347697 P0347698 P0348019 P0348020 P0351695 P0351696 P0351697 P0351698 P0351699 P0351700 P0351701 P0351702 P0351703 P0351704 P0359775 P0359776 P0359777 P0364832 P0366288 P0368638 P0370606 P0370607 P0370608 P0370609 P0370610 P0370611 P0370612 P0372027 P0374330 P0374331 P0375429 P0376903 P0377679 P0377744 P0377745 P0377746 P0377747 P0377748 P0378514 P0379987 P0381235 P0381836 P0382633 P0384118 P0384750 P0384751 P0387969 P0390734 P0391666 P0391667 P0391668 P0394335 P0394336 P0394337 P0394338 P0394339 P0394340 P0395345 P0395346 P0401336 P0405134 P0410338 P0410339 P0414745 P0414746 P0419047 P0419456 P0419457 P0422115 P0422116 P0422117 P0422118 P0422119 P0422120 P0422121 P0422122 P0422594 P0422595 P0422596 P0422597 P0422598 P0423117 P0423123 P0425107 P0425108 P0425109 P0425110 P0425111 P0425804 P0431051 P0431052 P0432060 P0432061 P0432062 P0432063 P0434092 P0434093 P0435933 P0436120 P0437597 P0452263 P0452264 P0452265 P0455326 P0455327 P0455328 P0455329 P0455696 P0455697 P0455698 P0455699 P0455700 P0455701 P0455702 P0455703 P0455704 P0455705 P0457753 P0457754 P0465381 P0465988 P0465989 P0465990 P0465991 P0465992 P0465993 P0470407 P0470408 P0471436 P0471437 P0481724 P0484917 P0484918 P0484919 P0484920 P0484921 P0485353 P0485354 P0485601 P0486393 P0486394 P0490287 P0490288 P0493996 P0493997 P0499754 P0499755 P0506485 P0506486 P0506487 P0506488 P0506522 P0506523 P0506524 P0506525 P0506720 P0506721 P0510073 P0513847 P0513848 P0514878 P0514879 P0514880 P0514881 P0514882 P0518862 P0518863 P0518864 P0522169 P0522170 P0523186 P0523255 P0526775 P0537038 P0538530 P0545938 P0545939 P0546360 P0546361 P0547885 P0547886 P0547887 P0547888 P0548293 P0549077 P0549298 P0554002 P0554006 P0557879 P0557881 P0558142 P0558149 P0558150 P0561460 P0561461 P0561462 P0563047 P0564486 P0564487 P0564488 P0567283 P0567284 P0568598 P0568599 P0568600 P0571553 P0571554 P0573535 P0573536 P0574068 P0574069 P0574070 P0574071 P0574373 P0574374 P0575340 P0575341 P0578497 P0581504 P0584754 P0585620 P0589457 P0589458 P0589459 P0589460 P0591198 P0591199 P0591200 P0591201 P0591675 P0591676 P0591677 P0593459 P0593460 P0593461 P0593675 P0596894 P0611489 P0611490 P0611491 P0613214 P0613215 P0613217 P0613218 P0619541 P0621146 P0622391 P0622957 P0622958 P0623009 P0623010 P0623011 P0623201 P0623202 P0623849 P0623850 P0627051 P0627052 P0627643 P0631898 P0631899 P0631900 P0631901 P0634421 P0634422 P0634423 P0636473 P0636474 P0636475 P0636476 P0636477 P0644179 P0644381 P0644382 P0646061 P0646062 P0646064 P0648700 P0648702 P0649054 P0649055 P0649056 P0649057 P0649065 P0650529 P0650530 P0650531 P0650532 P0650533 P0653810 P0653811 P0653812 P0653813 P0653814 P0653815 P0653816 P0653818 P0653819 P0653820 P0653821 P0653890 P0656079 P0656080 P0658383 P0658384 P0658385 P0658386 P0658387 P0658388 P0658389 P0661898 P0661899 P0661900 P0661901 P0661902 P0661903 P0661904 P0661905 P0662904 P0667417 P0669178 P0669179 P0670495 P0670496 P0672684 P0672686 P0678323 P0678324 P0678325 P0678326 P0678327 P0678328 P0678329 P0678330 P0680127 P0680128 P0680129 P0680130 P0681696 P0681697 P0686378 P0686379 P0686380 P0686381 P0687225 P0687226 P0687227 P0687228 P0687229 P0687230 P0687231 P0687232 P0687233 P0689827 P0689829 P0689830 P0689831 P0689832 P0690006 P0698683 P0703903 P0703905 P0703907 P0704130 P0704132 P0709303 P0709304 P0716385 P0716387 P0716388 P0716389 P0716390 P0721838 P0721839 P0721840 P0724942 P0724943 P0724944 P0724953 P0724954 P0725000 P0725001 P0725002 P0725301 P0727359 P0727360 P0727362 P0728880 P0729213 P0729216 P0729423 P0729424 P0729429 P0729430 P0730853 P0730854 P0733385 P0733386 P0733387 P0803357 P0803358 P0811127 P0811129 P0811130 P0824699 P0824700 P0827168 P0827169 P0827170 P0829378 P0829379 P0829380 P0829382 P0836780 P0839468 P0839592 P0841008 P0841016 P0841018 P0841313 P0841702 P0844209 P0846329 P0847494 P0847505 P0847507 P0848450 P0850712 P0850713 P0850719 P0850723 P0862434 P0863908 P0864752 P0866689 P0866690 P0866691 P0866692 P0869713 P0869714 P0870376 P0871976 P0871978 P0883016 P0883020 P0883622 P0886312 P0886314 P0889223 P0894812 P0894813 P0902737 P0907460 P0907461 P0907462 P0907463 P0907871 P0907878 P0907879 P0913721 P0913723 P0913724 P0913725 P0913726 P0913727 P0915775 P0915776 P0915787 P0917443 P0920111 P0920112 P0920113 P0920114 P0920115 P0920984 P0920985 P0920986 P0920987 P0921205 P0924852 P0924853 P0924854 P0927905 P0928089 P0928090 P0928091 P0928092 P0928093 P0928094 P0936716 P0936717 P0936720 P0936721 P0938653 P0938657 P0938660 P0939177
• FEI Number: 3007420694
• Recalling Firm/ Manufacturer: ARJOHUNTLEIGH POLSKA Sp. z.o.o.; Ul. Ks. Piotra Wawrzyniaka 2; Komorniki Poland
• Manufacturer 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.
• FDA Determined 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 patient. Failure to comply may result in unintentional side support opening while handling a patient, posing a fall risk. Refer to Pic.3. Unintentional opening of the side support is very unlikely if all instructions in the Instruction for Use (IFU) are followed. The locking mechanism may not return to its original position after accidental unlocking, but complete opening is unlikely if the person handling the patient is well trained and follows the IFU recommendations. Potential Risks: Failure to follow these instructions may result in patient fall, which can lead to a serious injury. Next Steps: 1. Review the enclosed Field Safety Notice and updated Instructions for Use (IFU) carefully. 2. Use the device as outlined in the IFU and perform the recommended checks. 3. Complete and return the Customer Response Form to your local Arjo representative, including details of any devices that have been sold or transferred to another facility. (Form attached to this notice) 4. Forward this alert and the updated IFU to all relevant personnel and any other organizations/persons who have received these devices. 5. Maintain awareness of this notice and the updated IFU at your site. If you have any questions or concerns regarding the safe operation of the side supports, please contact your Arjo representative. If you have any further questions or require assistance completing the Customer Respons
• Quantity in Commerce: 8780 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.