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U.S. Department of Health and Human Services

Class 2 Device Recall MV3 Bariatric Bed

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 Class 2 Device Recall MV3 Bariatric Bedsee related information
Date Initiated by FirmOctober 31, 2025
Date PostedDecember 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0918-2026
Recall Event ID 97953
Product Classification Bariatric bed - Product Code OSI
ProductStryker MV3 bariatric bed, Part Number 5900000001
Code Information GTIN 07613327419221. Serial Numbers: 2025013200138, 2025013200139, 2022013200001, 2022013200002, 2022013200003, 2021013200096, 2021013200098, 2021013200099, 2021013200102, 2021013200114, 2023013200036, 2023013200037, 2023013200038, 2023013200039, 2023013200040, 2023013200041, 2023013200042, 2025013200200, 2025013200201, 2024013200239, 2024013200240, 2025013200041, 2025013200042, 2024013200264, 2024013200265, 2024013200266, 2024013200267, 2025013200043, 2025013200156, 2025013200157, 2025013200158, 2025013200159, 2020013200136, 2020013200137, 2021013200017, 2025013200172, 2024013200156, 2024013200157, 2020013200103, 2021013200079, 2021013200080, 2021013200087, 2021013200089, 2021013200091, 2021013200092, 2021013200093, 2021013200218, 2021013200219, 2021013200247, 2021013200249, 2025013200084, 2025013200087, 2025013200088, 2025013200089, 2025013200090, 2025013200091, 2025013200160, 2025013200161, 2025013200085, 2025013200086, 2022013200178, 2024013200286, 2024013200188, 2024013200189, 2024013200171, 2024013200172, 2024013200173, 2024013200174, 2024013200176, 2024013200177, 2024013200175, 2024013200178, 2024013200179, 2025013200081, 2025013200001, 2025013200002, 2025013200025, 2025013200026, 2025013200027, 2024013200237, 2024013200258, 2024013200246, 2024013200247, 2024013200248, 2024013200249, 2021013200141, 2021013200142, 2024013200290, 2025013200149, 2025013200150, 2024013200250, 2024013200251, 2024013200252, 2020013200114, 2020013200115, 2024013200255, 2024013200256, 2024013200257, 2021013200278, 2023013200078, 2024013200232, 2024013200233, 2023013200003, 2023013200004, 2023013200005, 2023013200006, 2023013200007, 2023013200008, 2023013200009, 2023013200010, 2024013200120, 2022013200145, 2022013200146, 2021013200351, 2021013200352, 2021013200353, 2025013200012, 2025013200013, 2025013200111, 2025013200202, 2020013200012, 2022013200166, 2022013200167, 2024013200015, 2024013200234, 2024013200235, 2024013200236, 2021013200279, 2021013200280, 2021013200281, 2021013200282, 2021013200283, 2021013200284, 2024013200187, 2024013200106, 2024013200107, 2023013200011, 2025013200155, 2024013200141, 2024013200142, 2022013200186, 2023013200169, 2023013200170, 2025013200115, 2025013200116, 2025013200117, 2025013200118, 2025013200119, 2025013200120, 2025013200121, 2025013200122, 2021013200038, 2021013200039, 2021013200040, 2024013200104, 2024013200105, 2024013200241, 2024013200242, 2024013200190, 2024013200191, 2024013200192, 2024013200193, 2022013200029, 2022013200030, 2024013200261, 2022013200112, 2022013200113, 2022013200114, 2022013200115, 2023013200102, 2023013200103, 2025013200124, 2021013200122, 2021013200133, 2021013200134, 2023013200147, 2023013200148, 2024013200125, 2024013200300, 2023013200092, 2023013200093, 2023013200094, 2023013200096, 2023013200097, 2023013200098, 2023013200101, 2025013200062, 2025013200063, 2025013200064, 2025013200065, 2025013200066, 2022013200107, 2022013200144, 2023013200119, 2023013200120, 2023013200121, 2023013200122, 2023013200123, 2023013200124, 2023013200125, 2023013200126, 2023013200127, 2023013200128, 2023013200129, 2023013200130, 2023013200131, 2023013200132, 2023013200133, 2023013200134, 2023013200135, 2023013200136, 2023013200137, 2023013200138, 2023013200149, 2023013200150, 2023013200151, 2023013200152, 2023013200153, 2023013200154, 2023013200155, 2023013200156, 2023013200157, 2023013200158, 2023013200159, 2023013200160, 2023013200161, 2023013200162, 2023013200163, 2023013200164, 2023013200165, 2023013200166, 2023013200167, 2023013200168, 2024013200005, 2024013200006, 2024013200007, 2024013200008, 2024013200009, 2024013200010, 2024013200011, 2024013200012, 2024013200013, 2024013200014, 2024013200016, 2024013200017, 2024013200018, 2024013200019, 2024013200020, 2024013200021, 2024013200022, 2024013200023, 2024013200024, 2024013200025, 2024013200056, 2024013200057, 2024013200058, 2024013200059, 2024013200060, 2024013200061, 2024013200062, 2024013200063, 2024013200064, 2024013200065, 2024013200072, 2024013200073, 2024013200074, 2024013200075, 2024013200076, 2024013200077, 2024013200078, 2024013200079, 2024013200080, 2024013200081, 2024013200082, 2024013200090, 2024013200091, 2024013200092, 2024013200093, 2024013200094, 2024013200095, 2024013200096, 2024013200097, 2024013200098, 2024013200099, 2021013200021, 2021013200245, 2025013200192, 2025013200193, 2025013200194, 2025013200196, 2025013200195, 2025013200197, 2025013200198, 2025013200199.
Recalling Firm/
Manufacturer		 Stryker Medical Division of Stryker Corporation
3800 E Centre Ave
Portage MI 49002-5826
For Additional Information ContactVictoria Haney
269-389-8606
Manufacturer 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 Determined
Cause 2		Release of Material/Component prior to receiving test results
ActionStryker 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 in Commerce294 units
DistributionUS, nationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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