Z-0433-2024Class II

ProCuity bed series, model number 3009, item number: 3009PX-ZM-600

Name: Z-0433-2024 ProCuity bed series, model number 3009, item number: 3009PX-ZM-600
Creator: Stryker Medical Division of Stryker Corporation
Published: 2023-08-30
License: https://open.fda.gov/license/

Stryker Medical / initiated 2023-08-30 / Open, Classified / root cause: manufacturing process

FDA source

Stryker Medical Division of Stryker Corporation began a recall of ProCuity bed series, model number 3009, item number: 3009PX-ZM-600 on 2023-08-30. FDA classified it as Class II and gives the reason as "Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0433-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-30
Posted: 2023-12-01
Recalling firm: Stryker Medical
Product: ProCuity bed series, model number 3009, item number: 3009PX-ZM-600.
Product code: FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Root cause tag: manufacturing process
FDA 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 [email protected]. 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.
Distribution: Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.
Product codes and lots: UDI-DI (GTIN): 07613327541311. Serial numbers: 2201000173, 2110001895, 2203001506, 2110000413, 2110000411, 2208002037, 2208002030, 2208002019& 2212000691

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0433-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0424-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0425-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0426-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0427-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0428-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0429-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0430-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0431-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0432-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0433-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0434-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0435-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0436-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01

Product code FNL

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)