Recall Z-0918-2026 ยท OSI Bariatric Bed
Stryker Medical Division of Stryker Corporation
Stryker MV3 bariatric bed, Part Number 5900000001
| Date | Dec 11, 2025 (initiated Oct 31, 2025) |
| Status | Open, Classified |
| Reason | Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | Stryker issued an URGENT: VOLUNTARY MEDICAL DEVICE SAFETY notice to its sales representatives on 11/13/2025 for hand delivery to its consignees on 11/14/2025. The notice explained the issue, potential hazard, and requested the following: "Actions needed: 1. Locate the MV3 and Arise 1000EX devices that have been shipped to your facility. Serial numbers are provided on the enclosed business reply form. 2. If an MV3 is being used together with an Arise 1000EX mattress, Stryker recommends the use to be discontinued upon receipt of this notification. 3. Complete the enclosed business repl |
| Quantity | 294 units |
| Distribution | US, nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.