Stryker Medical Division of Stryker Corporation: Stryker Arise 1000EX mattress, Part Number 2236000000

Recall number

Z-0919-2026

Recalling firm

Stryker Medical Division of Stryker Corporation

Product

Stryker Arise 1000EX mattress, Part Number 2236000000

Status

Open, Classified

Initiated

2025-10-31

Posted

2025-12-11

Terminated

not on file

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 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.

Quantity

297 units

Distribution

US, nationwide

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

FNM

Firm FEI

1831750

Firm city

Portage

Firm state

MI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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