Stryker Medical Division Of Stryker Corporation recalls Stryker Arise 1000EX mattress
- Alternating Pressure Air Flotation Mattress
- Release of Material/Component prior to receiving test results
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Stryker Arise 1000EX mattress, Part Number2236000000GTIN 00857268006608297 affected lots10005028931000281054100028105510002810561000213521100021352210002135291000213530
+289 more
1000213531100021353210002135331000214321100021433110003771791000377180100037718110003822901000382291100038229210003822932009070914315010005376211000537622100048169510004818111000502644100050264510004694561000469457100046982110004698221000065720100006688810005026431000502895100050870210005100801000510081100051008210005100981000183920100018392110001840531000451149100045134710004855701000232648100023264910002326501000232651100023265210005124701000514147100051009510005100961000482548CU400-1983BA355214100045286710004528691000475796100047579710004758671000475868100048553710004855711000485538100047162710004718603100000471310000087410004861591000495054100049505510004847451000484746100048474710004568131000467673100048322810004832291000483465100048346610004834671000483468100046897510004689761000483230100051414810005141491000455365100045536710004568151000053839100018124410004823171000482318100048231910002760771000393550100048181310003707481000372689100037269010003726911000372692100037269310003726941000372695CU400-1375CU400-1447100045134610003610961000361097100042240710004224271000422428100048474810005028911000502892100053538810001602221000500377100050037810005006541000504503100050450410005045051000055394100026070210002607031000260704100045495610004358301000435831100051415010004469071000446908100033553910004117801000417224100000718510000071871000007188100000718910000464111000046735100004876210005124711000512474100051415110005141521000514153100051415410005141551000521760MX110241MX11024510004363701000436372100048254510004825461000482547100045495510004549571000455328100045532910003876061000387836100048016210003739211000373922100037392310003739241000389360100038936110005006551000431889100043189110004318921000431893100043189410004468311000481812100047694410004769451000479698100047969910004797001000480160100048016110004832311000483994100048399510004839961000483997310000027810003542591000413269100041327010004132711000413272100041722210004172231000418007100041800810004180091000422044100042204510004220461000422047100042209810004220991000422100100042210110004221021000422103100042210410004221051000422106100042210710004221081000422109100042240410004224051000422406100042242910004224301000422431100042243210004224331000422434100042651210004265131000426514100042651510004265161000426517100042651810004265191000426795100042679610004267971000426798100042679910004268001000426801100042680210004273411000427342100042734310004273441000427345100042734610004273471000427348100042734910004273501000427351100042735210004273531000427354100042735510004273561000427634100042763510004276361000427637100042763810004276391000427640100042764110004277011000427702100042770310004277041000427705100042770610004277071000427708100042809610004280971000428098100042809910004281001000428101100042810210004281031000428297100023264710005314021000531401100053140310005248791000524877100052487810005314001000524880
What the firm is doing
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.
DistributionShow detailsHide
US, nationwide
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0919-2026
- FDA device classification · FNMOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5550The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Stryker Medical Division of Stryker CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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