FDA Medical Device Recalls (openFDA)
Stryker Medical Division of Stryker Corporation: ProCuity bed series, model number 3009, item number: 3009PX-LEX-450.
- Recall number
- Z-0430-2024
- Recalling firm
- Stryker Medical Division of Stryker Corporation
- Product
- ProCuity bed series, model number 3009, item number: 3009PX-LEX-450.
- Status
- Open, Classified
- Initiated
- 2023-08-30
- Posted
- 2023-12-01
- Terminated
- not on file
- Reason
- Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
- Root cause
- Process control
- Action
- A customer notification was sent October 20, 2023 via FedEx. Users are to (1) Locate affected units and identify the address where they can be serviced. (2) Return the business reply form by fax +1 269 488-8691 or email to productfieldaction@stryker.com. Upon receipt of the completed business reply form, Stryker will contact you to arrange a time to complete the required electrical tests. (3) Forward notification to any new user/location and advise Stryker of the new address or device status if disposed of or obsolete using the reply form. Address questions or concerns to Customer Service at +1 800 327-0770 Monday through Friday from 8:00 a.m. to 6:00 p.m. ET.
- Quantity
- not on file
- Distribution
- Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.
- Lot, serial or model codes
- UDI-DI (GTIN): 07613327541236. Serial numbers: 2207000806 , 2101001244 , 2206000635 , 2206000628 , 2206000626 , 2206000483 , 2206000479 , 2206000412 , 2206000405 , 2206000401 , 2206000177 , 2205000560 , 2107001062 , 2107001046 , 2205000843 , 2205000841 , 2205000840 , 2205000836 , 2205000832 , 2208000197 , 2208000174 , 2208000156 , 2211002859 , 2205000935 , 2207001318 , 2207001289 , 2207001178 , 2207001163 , 2207001155 , 2207001114 , 2211000184 , 2211000209 , 2207001100 , 2207001097 , 2207001095 , 2207001600 , 2207001071 , 2207001037 , 2207001028 , 2204000753 , 2204000750 , 2204000542 , 2204000195 , 2203002255 , 2203002137 , 2203002129 , 2203001533 , 2203001527 , 2203001424 , 2203001163 , 2203000232 , 2203000230 , 2203000208 , 2203000044 , 2203000036 , 2203000033 , 2107001094 , 2203000005 , 2202001013 , 2202000678 , 2202000506 , 2104002546 , 2104002532 , 2104002512 , 2104002501 , 2104001704 , 2105005200 , 2103001843 , 2103001783 , 2102000290 , 2210003278 , 2208000758 , 2109002018 , 2011000511 , 2011000497 , 2202000089 , 2211004212 , 2109002745
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FNL
- 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