CLASS II ONGOING Device recall · Reported 17 Dec 2025 · FDA Enforcement Report
Stryker Arise 1000EX mattress recalled by Stryker Medical Division of
Stryker Medical Division of Stryker is recalling Stryker Arise 1000EX mattress, distributed nationwide in the US. The recall was initiated on 31 Oct 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0919-2026
- FDA event ID
- 97953
- Recalling firm
- Stryker Medical Division of Stryker, Portage, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Oct 2025
- FDA classified
- 11 Dec 2025
- Reported
- 17 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 31 Oct 2025 | Recall initiated by company | |
| 11 Dec 2025 | Classified by FDA | +41 days |
| 17 Dec 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Stryker Arise 1000EX mattress, Part Number 2236000000
Where it was distributed
US, nationwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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, 1000482318, 1000482319, 1000276077, 1000393550, 1000481813, 1000370748, 1000372689, 1000372690, 1000372691, 1000372692, 1000372693, 1000372694, 1000372695, CU400-1375, CU400-1447, 1000451346, 1000361096, 1000361097, 1000422407, 1000422427, 1000422428, 1000484748, 1000502891, 1000502892, 1000535388, 1000160222, 1000500377, 1000500378, 1000500654, 1000504503, 1000504504, 1000504505, 1000055394, 1000260702, 1000260703, 1000260704, 1000454956, 1000435830, 1000435831, 1000514150, 1000446907, 1000446908, 1000335539, 1000411780, 1000417224, 1000007185, 1000007187, 1000007188, 1000007189, 1000046411, 1000046735, 1000048762, 1000512471, 1000512474, 1000514151, 1000514152, 1000514153, 1000514154, 1000514155, 1000521760, MX110241, MX110245, 1000436370, 1000436372, 1000482545, 1000482546, 1000482547, 1000454955, 1000454957, 1000455328, 1000455329, 1000387606, 1000387836, 1000480162, 1000373921, 1000373922, 1000373923, 1000373924, 1000389360, 1000389361, 1000500655, 1000431889, 1000431891, 1000431892, 1000431893, 1000431894, 1000446831, 1000481812, 1000476944, 1000476945, 1000479698, 1000479699, 1000479700, 1000480160, 1000480161, 1000483231, 1000483994, 1000483995, 1000483996, 1000483997, 3100000278, 1000354259, 1000413269, 1000413270, 1000413271, 1000413272, 1000417222, 1000417223, 1000418007, 1000418008, 1000418009, 1000422044, 1000422045, 1000422046, 1000422047, 1000422098, 1000422099, 1000422100, 1000422101, 1000422102, 1000422103, 1000422104, 1000422105, 1000422106, 1000422107, 1000422108, 1000422109, 1000422404, 1000422405, 1000422406, 1000422429, 1000422430, 1000422431, 1000422432, 1000422433, 1000422434, 1000426512, 1000426513, 1000426514, 1000426515, 1000426516, 1000426517, 1000426518, 1000426519, 1000426795, 1000426796, 1000426797, 1000426798, 1000426799, 1000426800, 1000426801, 1000426802, 1000427341, 1000427342, 1000427343, 1000427344, 1000427345, 1000427346, 1000427347, 1000427348, 1000427349, 1000427350, 1000427351, 1000427352, 1000427353, 1000427354, 1000427355, 1000427356, 1000427634, 1000427635, 1000427636, 1000427637, 1000427638, 1000427639, 1000427640, 1000427641, 1000427701, 1000427702, 1000427703, 1000427704, 1000427705, 1000427706, 1000427707, 1000427708, 1000428096, 1000428097, 1000428098, 1000428099, 1000428100, 1000428101, 1000428102, 1000428103, 1000428297, 1000232647, 1000531402, 1000531401, 1000531403, 1000524879, 1000524877, 1000524878, 1000531400, 1000524880.
Where was it sold?
US, nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97953| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Stryker MV3 bariatric bed recalled by Stryker Medical Division of | Stryker Medical Division of Stryker | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Cub Pediatric Crib recalled by Stryker Medical Division of | Stryker Medical Division of Stryker | Other | Nationwide |
| Device | CLASS II | Stryker MV3 bariatric bed recalled by Stryker Medical Division of | Stryker Medical Division of Stryker | Other | Nationwide |
| Device | CLASS II | ProCuity bed series recalled by Stryker Medical Division of | Stryker Medical Division of Stryker | Other | Nationwide |
| Device | CLASS II | ProCuity bed series recalled by Stryker Medical Division of | Stryker Medical Division of Stryker | Other | Nationwide |
| Device | CLASS II | ProCuity bed series recalled by Stryker Medical Division of | Stryker Medical Division of Stryker | Other | Nationwide |
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