Z-0919-2026Class II

Stryker Arise 1000EX mattress, Part Number 2236000000

Name: Z-0919-2026 Stryker Arise 1000EX mattress, Part Number 2236000000
Creator: Stryker Medical Division of Stryker Corporation
Published: 2025-10-31
License: https://open.fda.gov/license/

Stryker Medical / initiated 2025-10-31 / Open, Classified

FDA source

Stryker Medical Division of Stryker Corporation began a recall of Stryker Arise 1000EX mattress, Part Number 2236000000 on 2025-10-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0919-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-31
Posted: 2025-12-11
Recalling firm: Stryker Medical
Product: Stryker Arise 1000EX mattress, Part Number 2236000000
Product code: FNM Mattress, Air Flotation, Alternating Pressure
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 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 [email protected]. 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 in commerce: 297 units
Distribution: US, nationwide
Product codes and 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, 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0919-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0918-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-11
Z-0919-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-11

Product code FNM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)