FDA Device recall Z-1400-2024
Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of p…
- FDA Device
- Class II
- ongoing
- Published 2024-04-10
On 2024-04-10 the FDA classified a Class II recall of Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of p… by Baxter Healthcare, citing inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter (ref number: FA-2022-026). You….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1400-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-05 |
| Published | 2024-04-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.
Reason
Inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter (ref number: FA-2022-026). Your devices have been identified as potentially impacted by these service inconsistencies and therefore, Baxter will need to reassess the impacted mattresses to confirm they have been corrected as identified by the service order, and to confirm the correct serial numbers have been identified.
Identifiers
| code_info | UDI/DI 00887761977884, Serial Numbers: W330BP6363, W333BP6439, W334BP6477, W334BP6535, W337BP6631, W341BP6675, X047BP7…UDI/DI 00887761977884, Serial Numbers: W330BP6363, W333BP6439, W334BP6477, W334BP6535, W337BP6631, W341BP6675, X047BP7353, X049BP7431, W330BP6365, W333BP6440, W334BP6478, W334BP6536, W337BP6632, W341BP6676, X047BP7354, X049BP7432, W330BP6366, W333BP6442, W334BP6480, W334BP6537, W337BP6633, W341BP6678, X047BP7355, X049BP7433, W330BP6367, W333BP6445, W334BP6481, W337BP6565, W337BP6634, W341BP6679, X047BP7356, X063BP7505, W330BP6368, W333BP6446, W334BP6485, W337BP6566, W337BP6635, W341BP6681, X047BP7357, X063BP7506, W330BP6382, W333BP6447, W334BP6486, W337BP6567, W337BP6636, W341BP6683, X047BP7358, X063BP7507, W330BP6383, W333BP6448, W334BP6487, W337BP6568, W337BP6637, W341BP6684, X047BP7359, X063BP7508, W330BP6385, W333BP6450, W334BP6489, W337BP6569, W337BP6638, W341BP6687, X047BP7360, X063BP7509, W330BP6387, W333BP6451, W334BP6492, W337BP6570, W337BP6641, X046BP7330, X047BP7361, X063BP7510, W330BP6397, W333BP6452, W334BP6493, W337BP6571, W337BP6642, X046BP7331, X047BP7362, X063BP7511, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1400-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.