Stryker Arise 1000EX mattress, Part Number 2236000000
Summary
The FDA issued a Class II for Stryker Arise 1000EX mattress, Part Number 2236000000 by Stryker Medical Division of Stryker Corporation. 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.
Details
Source
Device Recall
External ID
Z-0919-2026
Action Date
2025-12-17
Status
Ongoing
Category
device
Product Description
Stryker Arise 1000EX mattress, Part Number 2236000000
Lot/Code Info: 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.
Quantity Affected: 297 units
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.
Distribution
US, nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-31
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 244 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Medical Division of Stryker Corporation has 38 FDA actions in our database, including 38 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Medical Division of Stryker Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Medical Division of Stryker Corporation have FDA actions?
Stryker Medical Division of Stryker Corporation has 38 FDA actions in our database, including 38 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0919-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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