Recall Z-0919-2026
Stryker Medical Division of Stryker Corporation · initiated October 31, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Stryker Arise 1000EX mattress, Part Number 2236000000
Codes / lots: GTIN 00857268006608, Serial Numbers: 1000502893, 1000281054, 1000281055, 1000281056, 1000213521, 1000213522, 1000213529, 1000213530, 1000213531, 1000213532, 1000213533, 1000214321, 1000214331, 1000377179, 1000377180, 1000377181, 1000382290, 1000382291, 1000382292, 1000382293, 20090709143150, 1000537621, 1000537622, 1000481695, 1000481811, 1000502644, 1000502645, 1000469456, 1000469457, 1000469821, 1000469822, 1000065720, 1000066888, 1000502643, 1000502895, 1000508702, 1000510080, 1000510081, 1000510082, 1000510098, 1000183920, 1000183921, 1000184053, 1000451149, 1000451347, 1000485570, 1000232648, 1000232649, 1000232650, 1000232651, 1000232652, 1000512470, 1000514147, 1000510095, 1000510096, 1000482548, CU400-1983BA355214, 1000452867, 1000452869, 1000475796, 1000475797, 1000475867, 1000475868, 1000485537, 1000485571, 1000485538, 1000471627, 1000471860, 3100000471, 3100000874, 1000486159, 1000495054, 1000495055, 1000484745, 1000484746, 1000484747, 1000456813, 1000467673, 1000483228, 1000483229, 1000483465, 1000483466, 1000483467, 1000483468, 1000468975, 1000468976, 1000483230, 1000514148, 1000514149, 1000455365, 1000455367, 1000456815, 1000053839, 1000181244, 1000482317…
Reason for recall
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.
FDA-determined cause: Release of Material/Component prior to receiving test results
Action taken
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 reply form to confirm receipt of this notification. 4. Return your completed business reply form to Stryker by fax +1 269 488 8691 or email productfieldaction@stryker.com. 5. For those requesting a replacement of a compatible mattress, Stryker will contact you upon receipt of your Business Reply Form for next steps. 6. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise us of their new location." For questions or concerns, contact Customer Service at +1 800 327 0770, Option 1 for Customer Support, Monday through Friday from 8:00 a.m. to 7:00 p.m. ET.
Details
- Recall number
- Z-0919-2026
- Initiated
- October 31, 2025
- Posted by FDA
- December 11, 2025
- Product code
- FNM – Mattress, Air Flotation, Alternating Pressure
- Quantity
- 297 units
- Distribution
- US, nationwide
- Recalling firm
- Stryker Medical Division of Stryker Corporation, Portage, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0918-2026 Class II | Stryker MV3 bariatric bed, Part Number 5900000001Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these… | 10/31/2025Open, Classified |