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FDA Medical Device Recalls (openFDA)

Stryker Medical Division of Stryker Corporation: Stryker MV3 bariatric bed, Part Number 5900000001

Recall number
Z-0918-2026
Recalling firm
Stryker Medical Division of Stryker Corporation
Product
Stryker MV3 bariatric bed, Part Number 5900000001
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
294 units
Distribution
US, nationwide
Lot, serial or model codes
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.
510(k) numbers
not on file
PMA numbers
not on file
Product code
OSI
Firm FEI
1831750
Firm city
Portage
Firm state
MI
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

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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